1,439 Regulatory Writing jobs in the United States

Manager, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 7 days ago

Job Viewed

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Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.
The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). **While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.**
The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company
**Are you ready to join our team? Then please read further!**
**You will be responsible for:**
+ Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
+ Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
+ Lead and actively participate in setting functional tactics/strategy as needed.
+ Oversee the work of external contractors
+ Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
+ Guiding or training cross-functional team members on processes and best practices.
+ Potentially leading project-level/submission/indication writing teams.
+ If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
+ Actively participating in medical writing and cross-functional meetings.
+ Proactively provide recommendations for departmental process improvements.
+ Maintaining knowledge of industry, company, and regulatory guidelines.
+ Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
+ Interacting with senior cross-functional colleagues to strengthen coordination between departments.
+ Representing Medical Writing department in industry standards working groups if and as needed.
+ Complete all time reporting, training, and metrics database updates as required in relevant company systems.
+ If a people manager:
+ Manage a team of internal medical writers (direct reports).
+ Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
+ Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates.
+ Accountable for the quality of deliverables and for compliance of direct reports.
+ Participate in resource management and hiring decisions.
**Education and Experience Requirements:**
+ University/college degree required. Masters or PhD preferred.
+ At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
+ If a people manager, preferably up to 2 years of people management experience.
**Other Requirements:**
+ Experience of multiple therapeutic areas preferred.
+ Attention to detail.
+ Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
+ Expert project/time management skills.
+ Strong project/process leadership skills.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
+ Able to resolve complex problems independently.
+ Demonstrate learning agility.
+ Able to build and maintain solid and positive relationships with cross‐functional team members.
+ Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Netherlands, Belgium- Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $115,000 to $97,000 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**The anticipated base pay range for this position is :**
115,000 - 197,800 (USD)
Additional Description for Pay Transparency:
View Now

Manager, X-TA Regulatory Medical Writing

19436 Gwynedd, Pennsylvania Johnson and Johnson

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.

The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company

Are you ready to join our team? Then please read further!

You will be responsible for:
  • Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
  • Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
  • Lead and actively participate in setting functional tactics/strategy as needed.
  • Oversee the work of external contractors
  • Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
  • Guiding or training cross-functional team members on processes and best practices.
  • Potentially leading project-level/submission/indication writing teams.
  • If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
  • Actively participating in medical writing and cross-functional meetings.
  • Proactively provide recommendations for departmental process improvements.
  • Maintaining knowledge of industry, company, and regulatory guidelines.
  • Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
  • Interacting with senior cross-functional colleagues to strengthen coordination between departments.
  • Representing Medical Writing department in industry standards working groups if and as needed.
  • Complete all time reporting, training, and metrics database updates as required in relevant company systems.
  • If a people manager:
    • Manage a team of internal medical writers (direct reports).
    • Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
    • Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
    • Ensures direct report’s adherence to established policies, procedural documents, and templates.
    • Accountable for the quality of deliverables and for compliance of direct reports.
    • Participate in resource management and hiring decisions.
Education and Experience Requirements:
  • University/college degree required. Masters or PhD preferred.
  • At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
  • If a people manager, preferably up to 2 years of people management experience.

Other Requirements:

  • Experience of multiple therapeutic areas preferred.
  • Attention to detail.
  • Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
  • Expert project/time management skills.
  • Strong project/process leadership skills.
  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
  • Able to resolve complex problems independently.
  • Demonstrate learning agility.
  • Able to build and maintain solid and positive relationships with cross‐functional team members.
  • Solid knowledge and application of regulatory guidance documents such as ICH requirements.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-

Netherlands, Belgium- Requisition Number: R-

United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $115,000 to $97,000 (USD).

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

- Vacation - up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

- Holiday pay, including Floating Holidays - up to 13 days per calendar year

- Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-Hybrid

#LI-Remote

The anticipated base pay range for this position is :

$115,0 0 - 197,800 (USD)

Additional Description for Pay Transparency:

Apply Now

Associate Director, Regulatory Medical Writing - Oncology

19436 Gwynedd, Pennsylvania Johnson and Johnson

Posted 22 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-

Canada - Requisition Number: R-  

Netherlands, Germany, Spain, France - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.

Purpose:

  • Able to function as a lead writer on any compound independently.

  • Leads in setting functional tactics/strategy.

  • Leads project-level strategy (eg, submission team, global program team, clinical team).

  • May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority.

  • Able to write and coordinate complex documents within and across TAs independently.

  • Contributes to and champions internal standards, regulatory, and publishing guidelines.

  • Contributes to and champions the improvement of internal systems, tools, and processes.

  • Able to lead process working groups.

  • Able to oversee the work of external contractors.

  • May have additional major responsibility with supervision:

    • Cross-functional, cross-TA, or cross-J&J initiative/collaboration.

    • Larger organizational responsibility (eg, manage a subset of TA).

  • If a people manager:

    • Manages a team of internal medical writers (direct reports).

    • Accountable for the quality of deliverables and compliance of direct reports.

    • Actively participates in resource management and hiring decisions.

You will be responsible for:

  • Able to lead compound/submission/indication/disease area writing teams independently.

  • Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.

  • Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.

  • Establishes and drives document timelines and strategies independently.

  • Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.

  • Proactively identifies and champions departmental process improvements.

  • May develop and present best practices or innovations to internal or external audiences.

  • May lead cross-functional, cross-TA, or cross-J&J process improvement initiatives.

  • Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).

  • Maintains and disseminates knowledge of industry, company, and regulatory guidelines.

  • Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required in relevant company systems.

  • Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.

  • If applicable, has lead MW responsibilities for providing guidance on deliverables, content, etc.

  • Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.

  • May represent MW in industry standards working groups.

  • As a MW lead, is the primary point of contact for MW activities for the cross-functional team (eg, clinical).

  • If a people manager:

    • Supervises/manages and is accountable for direct reports.

    • Sets objectives and agrees on goals for direct reports. Provides performance oversight, including feedback on performance and development.

    • Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.

    • Ensures direct report’s adherence to established policies, procedural documents, and templates.

  • Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Qualifications / Requirements:

  • A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

  • At least 10 years of relevant pharmaceutical/scientific experience is required.

  • At least 8 years of relevant clinical/regulatory medical writing experience is required.

  • Experience in project management and process improvement is required.

  • If a people manager: at least 2 years of people management experience is required.

  • Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

  • Resolves complex problems independently.

  • Advanced knowledge and application of regulatory guidance documents such as ICH requirements

  • Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups.

  • Proactively identifies potential risks and develops strategies to mitigate.

  • Identifies and resolves problems related to development and implementation of new service offerings/deliverables.

  • Ability to serve as the liaison between team members and senior leadership within a TA.

  • Excellent oral and written communication skills.

  • Attention to detail.

  • Expert time management for self, direct reports (if applicable), and teams.

  • Ability to build and maintain solid and productive relationships with cross-functional team members.

  • Expert project management skills, expert project/process leadership.

  • Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).

  • Ability to delegate responsibility to junior writers.

  • Ability to lead by example, stay focused and positive, and act with integrity.

  • Ability to internalize and teach CREDO behaviors.

  • Ability to act as change agent and adapt to rapidly changing organizational & business challenges.

  • If a people manager: Strong people management skills.

The anticipated base pay range for this position is to .

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

The anticipated base pay range for this position is to .

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.

Apply Now

Associate Director, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 6 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for an **Associate Director, Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area.
This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Are you ready to join our team? Then please read further!
**You will be responsible for:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
+ Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ If a people manager, at least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-
United States (East Coast)- Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD)
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**The anticipated base pay range for this position is :**
137,000-235,750 USD
Additional Description for Pay Transparency:
View Now

Associate Director, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania Johnson and Johnson

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for an Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area.

This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Are you ready to join our team? Then please read further!

You will be responsible for:

  • Leading compound/submission/indication/disease area writing teams independently.
  • May have additional major responsibility with supervision.
  • Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
  • Larger organizational responsibility (eg, manage a subset of TA).
  • Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
  • Leading program-level/submission writing teams independently.
  • Directly leading or setting objectives for others on team projects and tasks.
  • Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
  • Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
  • Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
  • Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
  • If a lead writer for a program:
    • Primary point of contact and champion for Medical Writing activities for the clinical team.
    • Responsible for planning and leading the writing group for assigned program.
    • Able to function as a lead writer on any compound independently.
    • Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
    • Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
    • Able to oversee the work of external contractors.
  • As a people manager:
    • Manage direct reports in Medical Writing.
    • Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
    • Ensures direct report’s adherence to established policies, procedural documents, and templates
    • Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
Qualifications /Requirements:
  • University/college degree in a scientific discipline is required. Masters or PhD preferred.
  • At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
  • If a people manager, at least 2 years of people management experience.
  • Multiple therapeutic area experience preferred.
  • Strong attention to detail.
  • Strong oral and written communication skills. Fluent written and spoken English.
  • Expert project management skills, expert project/process improvement leadership.
  • Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
  • Ability to delegate responsibility to junior writers.
  • Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-

Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-

United States (East Coast)- Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $137,000 to $235,750 (USD)

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

- Vacation - up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

- Holiday pay, including Floating Holidays - up to 13 days per calendar year

- Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-Hybrid

#LI-Remote

The anticipated base pay range for this position is :

137,000-235,750 USD

Additional Description for Pay Transparency:

Apply Now

Senior Manager/Associate Director, Regulatory Medical Writing, Immunology

19477 Spring House, Pennsylvania Johnson and Johnson

Posted 10 days ago

Job Viewed

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Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Senior Manager/Associate Director , Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. 

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.  

You will be responsible for: 

  • Leading compound/submission/indication/disease area writing teams independently. 
  • Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
  • Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
  • Establishing and driving document timelines and strategies independently.
  • Guiding or training cross-functional team members on processes and best practices.
  • Proactively identifying and championing departmental process improvements.
  • May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
  • Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
  • Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
  • Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

  • Supervising/managing and being accountable for direct reports.
  • Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development. 
  • Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. 
  • Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
  • Ensuring direct report’s adherence to established policies, procedural documents, and templates. 
  • Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. 

Qualifications /Requirements: 

  • A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. 
  • At least 10 years of relevant pharmaceutical/scientific experience.
  • At least 8 years of relevant clinical/regulatory medical writing experience.
  • At least 2 years of direct people management experience. 
  • Experience in project management and process improvement.
  • Advanced knowledge and application of regulatory guidance such as ICH requirements
  • Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
  • Resolves complex problems independently.
  • Proactively identifies potential risks and develops strategies to mitigate.
  • Ability to serve as the liaison between team members and senior leadership within a therapy area.
  • Ability to build and maintain solid and positive relationships with cross-functional team members.
  • Excellent oral and written communication skills.
  • Attention to detail.
  • Expert time management for self and team.
  • Expert project management skills, expert project/process leadership.
  • Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
  • Ability to delegate responsibility to junior writers.
  • Ability to lead by example, stay focused and positive, and act with integrity.
  • Ability to internalize and teach CREDO behaviours.
  • Ability to act as change agent and adapt to rapidly changing organizational & business challenges.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): 

  • United Kingdom - Requisition Number: R-
  • Belgium, Netherlands - Requisition Number: R-
  • Switzerland - Requisition Number: R- 
  • United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 

For United States applicants: 

The anticipated base pay range for this position is $137,000 to $235,750 (USD).  

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.  

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, denta l, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.  

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).  

Employees are eligible for the following time off benefits: 

- Vacation - up to 120 hours per calendar year  

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year 

- Holiday pay, including Floating Holidays - up to 13 days per calendar year  

- Work, Personal and Family Time - up to 40 hours per calendar year  

For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  

#LI-Hybrid 

#LI-Remote 

The anticipated base pay range for this position is :

137,000 - 235,700 USD

Additional Description for Pay Transparency:

Apply Now

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

08560 Titusville, New Jersey J&J Family of Companies

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring** **House/Raritan/Titusville** **(East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
+ Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ At least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $35,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**The anticipated base pay range for this position is :**
137,000 to 235,750 (USD)
Additional Description for Pay Transparency:
View Now
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About the latest Regulatory writing Jobs in United States !

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

08560 Titusville, New Jersey Johnson and Johnson

Posted 8 days ago

Job Viewed

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Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at  

We are searching for the best talent for a Senior Manager/Associate Director , Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area. 

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland) or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.  

Are you ready to join our team? Then please read further!  

You will be responsible for: 
  • Leading compound/submission/indication/disease area writing teams independently. 

  • May have additional major responsibility with supervision. 

  • Cross-functional, cross-TA, or cross-J&J initiative/collaboration. 

  • Larger organizational responsibility (eg, manage a subset of TA). 

  • Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking. 

  • Leading program-level/submission writing teams independently. 

  • Directly leading or setting objectives for others on team projects and tasks. 

  • Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers. 

  • Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. 

  • Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups. 

  • Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. 

  • If a lead writer for a program: 

  • Primary point of contact and champion for Medical Writing activities for the clinical team. 

  • Responsible for planning and leading the writing group for assigned program. 

  • Able to function as a lead writer on any compound independently. 

  • Leading discussions in Medical Writing and cross‐functional meetings as appropriate. 

  • Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. 

  • Able to oversee the work of external contractors. 

  • As a people manager: 

  • Manage direct reports in Medical Writing. 

  • Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. 

  • Ensures direct report’s adherence to established policies, procedural documents, and templates 

  • Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions. 

Qualifications /Requirements: 

  • University/college degree in a scientific discipline is required. Masters or PhD preferred. 

  • At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! 

  • At least 2 years of people management experience. 

  • Multiple therapeutic area experience preferred. 

  • Strong attention to detail. 

  • Strong oral and written communication skills. Fluent written and spoken English. 

  • Expert project management skills, expert project/process improvement leadership. 

  • Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. 

  • Ability to delegate responsibility to junior writers. 

  • Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers. 

  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently. 

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): 

    • United Kingdom - Requisition Number: R-  
    • Belgium, Netherlands - Requisition Number: R-
    • Switzerland - Requisition Number: R-  
    • United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 

For United States applicants: 

The anticipated base pay range for this position is $137,000 to $35,750 (USD).  

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.  

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.  

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).  

Employees are eligible for the following time off benefits: 

- Vacation - up to 120 hours per calendar year  

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year 

- Holiday pay, including Floating Holidays - up to 13 days per calendar year  

- Work, Personal and Family Time - up to 40 hours per calendar year  

For additional general information on company benefits, please go to:

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  

#LI-Hybrid 

#LI-Remote 

The anticipated base pay range for this position is :

$137,000 to $235,750 (USD)< >Additional Description for Pay Transparency:

Apply Now

Clinical Documentation Manager

HealthSearch Group

Posted today

Job Viewed

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Job Description

Job Title: Manager, Clinical Documentation Integrity (CDI) & DRG Denials


Are you passionate about driving excellence in clinical documentation and leading high-performing teams? We are seeking a Manager of Clinical Documentation Integrity (CDI) & DRG Denials to lead our CDI department and oversee the DRG denials appeals process within a growing, award-winning health system serving a diverse community in the beautiful Hudson Valley.

This is an opportunity to join a patient-centered, forward-thinking organization where collaboration, innovation, and quality care are at the core of everything we do.


Key Responsibilities

  • Lead the day-to-day operations of the CDI department and DRG denials process.
  • Develop, implement, and evaluate policies and procedures related to clinical documentation improvement across multiple hospital sites.
  • Ensure medical record reviews are conducted to assess appropriateness and medical necessity for admission and continued stay.
  • Facilitate improvement in the quality, completeness, and accuracy of medical record documentation.
  • Collaborate closely with outcomes managers and coding denial coordinators to review and write compelling appeals for third-party denials.


Qualifications

Education:

  • Bachelor’s Degree in Nursing (required).

Experience:

  • Minimum 5 years of progressive experience in an acute care hospital (100+ beds).
  • Minimum 5 years of experience in the CDI industry.
  • Strong knowledge of ICD-10 diagnosis coding, CPT coding guidelines, DRG-based reimbursement, and DRG/coding appeal process.
  • Exceptional communication skills with physicians and clinical staff.

Licenses/Certifications:

  • Current NY State RN license (required).
  • Certified Clinical Documentation Specialist (CCDS) credential (required).
View Now

Clinical Documentation Specialist

60007 Elk Grove Village, Illinois Ascension Health

Posted 1 day ago

Job Viewed

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Job Description

**Details**
+ **Department:** Population Health Quality Department
+ **Schedule:** Full-time Hybrid - 1-2 days of onsite work required
+ **Hospital:** Ascension Alexian Brothers
+ **Location:** Elk Grove Village, IL
+ **Salary:** $79,059.75 - $110,204.85 per year
Must live in Illinois due to weekly travel requirement
**Benefits**
Paid time off (PTO)
Various health insurance options & wellness plans
Retirement benefits including employer match plans
Long-term & short-term disability
Employee assistance programs (EAP)
Parental leave & adoption assistance
Tuition reimbursement
Ways to give back to your community
_Benefit options and eligibility vary by position. Compensation varies based on factors including, but not limited to, experience, skills, education, performance, location and salary range at the time of the offer._
**Responsibilities**
Facilitate improvement in overall quality, completeness and accuracy of medical record documentation.
+ Complete admission reviews and assign a working Diagnosis Related Group.
+ Ensure the working DRG and other information are entered in the Clinical Documentation Improvement database.
+ Initiate and maintain extensive interactions with physicians and mid-level providers to address the need for more detailed information in the medical record.
+ Collaborate with healthcare professionals to ensure the severity of illness and level of services provided are accurately reflected in the medical record and to resolve physician queries and documentation issues prior to patient's discharge.
+ Maintain accurate records of review activities, ensuring reports and outcomes of CDI efforts are valid.
**Requirements**
Licensure / Certification / Registration:
+ One or more of the following required:- Certified Coding Specialist (CCS) credentialed from the American Health Information ManagementAssociation (AHIMA) obtained prior to hire date or job transfer date.- Certified Professional Coder (CPC) credentialed from the American Academy of Professional Coders(AAPC) obtained prior to hire date or job transfer date.- Clinical Documentation Prof. credentialed from the Association of Clinical Documentation ImprovementSpecialists obtained prior to hire date or job transfer date.- Registered Nurse credentialed from the Illinois Department of Financial and Professional Regulationobtained prior to hire date or job transfer date.- Reg Health Info Admnstr credentialed from the American Health Information Management Association(AHIMA) obtained prior to hire date or job transfer date.- Reg Health Info Tech credentialed from the American Health Information Management Association(AHIMA) obtained prior to hire date or job transfer date.
+ Preferred Credential(s):- Approved Local Exception
Education:
+ High School diploma equivalency with 2 years of cumulative experience OR Associate'sdegree/Bachelor's degree OR 4 years of applicable cumulative job specific experience required.
**Additional Preferences**
**Minimum Requirements:**
+ **Medical Assistants with ICD-10 coding experience strongly recommended to apply**
+ **Required Certifications/Licensure:** Candidates must have the following certification thru AAPC (credentialing board): **Certified Risk Adjustment Coder (CRC) - STRONGLY PREFERRED**
+ **Hybrid position** - Flexible with local IL traveling, required (Northwest and Chicago Metro facilities) - **must reside in Illinois due to travel requirement**
+ **Minimum Education:** High School Diploma or Equivalent
+ **Minimum Years of Experience:**
+ **Current Students in the CRC program please apply!**
+ 1 year **RISK CODING** experience, preferred (NEW GRADUATES WELCOME)
+ Experience in HCC or chronic condition coding
+ Experience in medical practice outpatient setting
**Why Join Our Team**
Ascension Illinois delivers compassionate, personalized care throughout Chicago and its surrounding suburbs. As one of the largest health systems in Illinois with 15 hospitals and more than 230 sites of care, you will find an environment that allows you to thrive and create a career path you love. Join a diverse team of more than 17,000 associates and more than 600 providers who are dedicated to providing compassionate, personalized care to all.
Ascension is a leading non-profit, faith-based national health system made up of over 134,000 associates and 2,600 sites of care, including more than 140 hospitals and 40 senior living communities in 19 states.
Our Mission, Vision and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make a positive impact in their community. Ascension careers are more than jobs; they are opportunities to enhance your life and the lives of the people around you.
**Equal Employment Opportunity Employer**
Ascension provides Equal Employment Opportunities (EEO) to all associates and applicants for employment without regard to race, color, religion, sex/gender, sexual orientation, gender identity or expression, pregnancy, childbirth, and related medical conditions, lactation, breastfeeding, national origin, citizenship, age, disability, genetic information, veteran status, marital status, all as defined by applicable law, and any other legally protected status or characteristic in accordance with applicable federal, state and local laws.
For further information, view the EEO Know Your Rights (English) ( poster or EEO Know Your Rights (Spanish) ( poster.
As a military friendly organization, Ascension promotes career flexibility and offers many benefits to help support the well-being of our military families, spouses, veterans and reservists. Our associates are empowered to apply their military experience and unique perspective to their civilian career with Ascension.
Pay Non-Discrimination Notice ( note that Ascension will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Ascension will not solicit money or banking information from applicants.
**E-Verify Statement**
This employer participates in the Electronic Employment Verification Program. Please click the E-Verify link below for more information.
E-Verify (
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