2,923 Medical Writers jobs in the United States

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.
About the role:
The Principal Medical Writer is responsible for providing writing support and advanced scientific writing expertise to the teams, ensuring successful preparation of high-quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups to ensure accurate and timely completion/delivery of information and review of assigned writing projects. Serves as the scientific writing expert for the department.
Responsibilities
+ Serves as medical writing lead on more complex writing assignments. Works closely with in-function and cross-functional team(s) on document strategies. Implements all activities related to the preparation of writing projects.
+ Serves as a subject matter expert within department for assigned therapeutic/product areas.
+ Converts relevant data and information into a form that meets writing project requirements. Explains data in manner consistent with the target audience(s) and requirements for the project. Coordinates the review, approval, and other appropriate functions involved in the production of writing. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
+ Responsible for effective communication among project team members and contributors to assigned project. Communicates deliverables needed, writing process, and timelines. Holds team members and contributors accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
+ Understands, assimilates, and interprets sources of info with appropriate guidance/direction from project teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
+ Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project.
+ Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing projects.
+ Works with journal/congress throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary.
+ Maintains expert knowledge of US and international regulations, requirements and guidance associated with preparation of writing projects. Advises teams regarding compliance with guidelines or regulations. Learns and applies knowledge of therapeutic area and product to scientific publishing projects.
+ Serves as a department representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments. Coaches, mentors, and assists more junior medical writers. Provides guidance to non-AbbVie medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.
Qualifications
+ Bachelor of Science required, with significant relevant writing experience, or Bachelor's degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
+ American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
+ 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D.
+ 2 years relevant industry experience preferred.
+ 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
+ High-level content writing experience and experience with all types of writing projects. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
+ Expert knowledge of US and international regulations, requirements and guidance associated with preparation of assigned writing project sand ability to advise teams regarding compliance with regulations. Expert knowledge and experience working with templates and relevant systems
+ Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
+ Extensive experience in working with collaborative, cross-functional teams, including project management experience. Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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.

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 the 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.
• May have additional major responsibility with supervision.
• Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
• Larger organizational responsibility (e.g., 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 $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:

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

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:

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:

Job Summary

Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!

This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our PACE® Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.

WE OFFER THE FOLLOWING

• Competitive travel bonus;
• Equity/Stock Option Program;
• Training completion and retention bonus
• Annual merit increases;
• 401K matching;
• The opportunity to work from home;
• Flexible work hours across days within a week;
• Retain airline reward miles and hotel reward points;
• Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
• In-house travel agents, reimbursement for airline club, and TSA pre-check;
• Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
• CRA training program (PACE®);
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
• In-house administrative support for all levels of CRAs; and
• Opportunities to work with international team of CRAs.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per
• SOPs, GCP, and applicable regulatory requirements;
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Must have a minimum of a Bachelor's degree in a health or science related field;
• Experience as a Clinical Research Coordinator (minimum 1 year);
• Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
• Must maintain a valid driver's license and the ability to drive to monitoring sites;
• Proficient knowledge of Microsoft® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.

#LI-Remote

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Cincinnati Campus Overview
• Flexible work environment
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

Awards

• Named a Top Workplace in 2024 by The Cincinnati Enquirer
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities

Job Summary:

Manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance.

Essential Functions:

* Demonstrates current knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.
* Ensures study documents are maintained in compliance with applicable regulations, guidelines and policies (ie- FDA, OHRP, IRB)
* Complies with licensure, contractual, protocol and policy requirements
* Directs intradepartmental and external resource activities relating to assigned studies
* Assists in the review and development of proposed study budgets
* Ensures compliance with all study billing process requirements
* Collaborates with the Principal Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting
* Completes and submits reports and regulatory documents to study sponsor, Institutional Review Board, or appropriate agency within established time frames
* Provides study specific and individualized education to patients, families, colleagues and community using various teaching strategies.
* Insures all departments participating in a study are in-serviced and maintains documentation of training
* Acts as a liaison between patient, investigator, sponsor and cooperative centers

Qualifications

Minimum:

Education and Experience:

* Bachelor's degree or equivalent combination of education and experience
* Master's degree preferred
* One year of clinical RN experience
* One year of RN experience within clinical research preferred

Overview

Hello humankindness

Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's.

U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.

Look for us on Facebook and follow us on Twitter.

For the health of our community . we are proud to be a tobacco-free campus.

Responsibilities

The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients.

Our day-to-day interactions with patients, caregivers and each other are grounded in transparency: our conversations are always two-way, and our labs are open to ensure efficient collaboration. Everyone at the Ivy Brain Tumor Center is passionate about identifying and accelerating treatments that will make a meaningful difference in patients' lives. Here, innovation never stops - because for us, this work is personal.

Visit us at Ivybraintumorcenter.org, and follow us on Facebook, Twitter, Instagram, LinkedIn and YouTube

Job Summary:

The Ivy Research Nurse Clinician plays an integral role for leading the coordination and management of the assigned protocols. Job duties will include screening potential patients for eligibility, providing study specific education to patients, families, and colleagues, conducting informed consent discussions and visits, and acting as a liaison with internal and external stakeholders involved in the clinical trial activities. Demonstrating knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH/GCP guidelines is required. This position interacts with a variety of people, both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high-volume clinical trial setting is required.

Manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance.

Principal Duties and Responsibilities:

* Participate in study development including protocol review, informed consent review and create study tools for the conduct of a clinical trial.
* Provide nursing expertise to the research team during study development and implementation.
* Facilitate education of the interdisciplinary team on study requirements.
* Identify and assist with procuring equipment and supplies for the trial requirements.
* Facilitate the initial and ongoing informed consent/assent process with research participants.
* Ensure the trial is conducted according to the protocol, ICH/GCP and FDA guidelines.
* Administer study treatment interventions.
* Collect specimens (blood, urine, CSF, tumor samples) for clinical and research testing.
* Facilitate the processing and shipment of research specimens as defined in the study protocol or lab manual(s).
* Obtain medical histories and conduct safety assessments such as vital signs, EKGs and report potential adverse events.
* Record research data in approved source documents and into study-specific databases. Review and respond to data queries in a timely manner.
* Prepare for and participate in site monitoring visits and/or audits.
* Assist with process improvement projects.
* Assist in the development of Standard Operating Procedures and Work Instructions.
* Performs miscellaneous job-related duties as assigned.

Qualifications

One year of RN clinical experience or combination of education and experience required

BSN or equivalent combination of education and experience required

One year of experience within clinical research preferred

Master's degree preferred

Overview

Hello humankindness

Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's.

U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.

Look for us on Facebook and follow us on Twitter.

For the health of our community . we are proud to be a tobacco-free campus.

**Responsibilities**

The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients.

Our day-to-day interactions with patients, caregivers and each other are grounded in transparency: our conversations are always two-way, and our labs are open to ensure efficient collaboration. Everyone at the Ivy Brain Tumor Center is passionate about identifying and accelerating treatments that will make a meaningful difference in patients' lives. Here, innovation never stops - because for us, this work is personal.

Visit us at Ivybraintumorcenter.org , and follow us on Facebook ( , Twitter ( , Instagram ( , LinkedIn ( and YouTube ( Summary:

The Ivy Research Nurse Clinician plays an integral role for leading the coordination and management of the assigned protocols. Job duties will include screening potential patients for eligibility, providing study specific education to patients, families, and colleagues, conducting informed consent discussions and visits, and acting as a liaison with internal and external stakeholders involved in the clinical trial activities. Demonstrating knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH/GCP guidelines is required. This position interacts with a variety of people, both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high-volume clinical trial setting is required.

Manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance.

Principal Duties and Responsibilities:

+ Participate in study development including protocol review, informed consent review and create study tools for the conduct of a clinical trial.

+ Provide nursing expertise to the research team during study development and implementation.

+ Facilitate education of the interdisciplinary team on study requirements.

+ Identify and assist with procuring equipment and supplies for the trial requirements.

+ Facilitate the initial and ongoing informed consent/assent process with research participants.

+ Ensure the trial is conducted according to the protocol, ICH/GCP and FDA guidelines.

+ Administer study treatment interventions.

+ Collect specimens (blood, urine, CSF, tumor samples) for clinical and research testing.

+ Facilitate the processing and shipment of research specimens as defined in the study protocol or lab manual(s).

+ Obtain medical histories and conduct safety assessments such as vital signs, EKGs and report potential adverse events.

+ Record research data in approved source documents and into study-specific databases. Review and respond to data queries in a timely manner.

+ Prepare for and participate in site monitoring visits and/or audits.

+ Assist with process improvement projects.

+ Assist in the development of Standard Operating Procedures and Work Instructions.

+ Performs miscellaneous job-related duties as assigned.

**Qualifications**

One year of RN clinical experience or combination of education and experience required

BSN or equivalent combination of education and experience required

One year of experience within clinical research preferred

Master's degree preferred

**Overview**

Hello humankindness ( conveniently in the heart of Phoenix, Arizona, ( St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute ( , Norton Thoracic Institute ( , Cancer Center at St. Joseph's ( , Ivy Brain Tumor Center ( , and St. Joseph's Level I Trauma Center ( (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's.

_U.S News & World Report_ routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies ( .

Look for us on Facebook ( and follow us on Twitter ( .

_For the health of our community . we are proud_ _to be_ _a tobacco-free campus._

**Pay Range**

$32.38 - $48.17 /hour

We are an equal opportunity/affirmative action employer.

Piper Clinical Solutions is actively seeking clinical research nurses for a large research center in Philadelphia PA. This position is working Monday through Friday 9am to 5pm with flexibility to work from home 1-2 days per week.

Responsibilities for Clinical Research Nurse - RN:

* Oversee clinical trials for cancer research including recruiting patients, enrolling patients, consenting patients, administering drug product to patients, and managing care of the patient during the clinical research trial.
* Educate patients on clinical trial protocols, enrollment process, side effects, follow up visits, and at home care.
* Coordinate with principal investigator (MD, DO, NP, PA) to ensure quality of care and cost-effective care for the patients.
* Review medical charts, extract data, input data, and write up summaries in relation to the clinical trial.

Technical Requirements for Clinical Research Nurse - RN:

* Must be a certified RN with an active Pennsylvania state license.
* At least 3 years of hands on patient care experience including ICU, critical care, CCU, ED and/or med surg floor.
* Excellent written, verbal, communication, and organizational skills.
* Must have experience with EMR systems, word processing applications and excel spreadsheets.
* Hands on experience with evaluating medical records, charts and care plans.

Compensation & Benefits for Clinical Research Nurse - RN:

* Compensation: based on experience
* Full Benefits: Medical, Dental, Vision, 401k, etc