1,782 Medical Information jobs in the United States

Assoc Director, Medical Information United States - California - Foster City Medical Affairs Regular Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Overview :

• Responds to unsolicited medical requests regarding Gilead products from HCPs, members of the public, and internal Gilead colleagues. Responses are provided in a timely manner using approved scientific response documents, up-to-date literature support, and other resources
• Uses scientific and MI expertise to drive strategic initiatives and empower Gilead partners, HCPs, and patients to enable timely, informed decisions and improved patient outcomes
• Performs appropriate medical review for promotional and/or medical materials
• Prepares global scientific resources in collaboration with local affiliate teams
• Identifies, reports and records adverse events and product complaints in a timely manner in accordance with SOP.
• Contributes to development of GMI strategy and represents GMI cross-functionally
• May lead department-wide and/or global projects, initiatives, and product launches

Responsibilities :

Routine responsibilities may include the following:

• Develop and maintain a deep knowledge of product, disease state and competitor landscape for assigned therapeutic area
• Respond to unsolicited requests for medical and scientific information regarding Gilead products and documents in the request handling system
• Research and collaborate with cross-functional colleagues to address complex requests.
• Create, update, and participate in review, quality check and approval of MI response documents
• Collaborate with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content
• Prepare and approve data on file to support response documents and complex requests
• Maintain document repository with routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Understand the needs and preferences of internal and external partners and customers
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• Participate and support MI booths at scientific congresses
• Serve as liaison for department specific training for new staff members, cross-functional colleagues and vendors, as required
• Contribute to departmental strategic initiatives by supporting key activities within the TA, including product launches, labeling updates, patient engagement etc.
• Execute and drive global MI initiatives and actions in a timely way to advance the provision of MI to improve patient care
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP
• Serve as department SME for one or more product(s) or TA
• Build and cultivate relationships with appropriate functions

Knowledge and Skills :

• Excellent written, verbal and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
• Ability to create and clearly communicate scientific data for different audiences,
• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment
• Ability to analyze and evaluate clinical, biomedical and scientific data
• Demonstrates Gileads core values and Leadership Commitments
• Has a strong attention to detail, excellent project management and problem-solving skills
• Previous experience with problem-solving and project management preferred

Basic Qualifications:

• Doctorate and 5+ years of relevant experience OR
• Masters and 8+ years of relevant experience OR
• Bachelors and 10+ years of relevant experience OR

Preferred Qualifications:

• Pharmacy, Nursing or Medical/ Life Sciences degree/advanced degree or equivalent
• Experience in MI preferred or comparable experience within a healthcare/clinical environment
• Experience in the pharmaceutical industry or a MI vendor
• Experience in conducting medical/promotional reviews

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Overview :

• Responds to unsolicited medical requests regarding Gilead products from HCPs, members of the public, and internal Gilead colleagues. Responses are provided in a timely manner using approved scientific response documents, up-to-date literature support, and other resources
• Uses scientific and MI expertise to drive strategic initiatives and empower Gilead partners, HCPs, and patients to enable timely, informed decisions and improved patient outcomes
• Performs appropriate medical review for promotional and/or medical materials
• Prepares global scientific resources in collaboration with local affiliate teams
• Identifies, reports and records adverse events and product complaints in a timely manner in accordance with SOP.
• Contributes to development of GMI strategy and represents GMI cross-functionally
• May lead department-wide and/or global projects, initiatives, and product launches

Responsibilities :

Routine responsibilities may include the following:

• Develop and maintain a deep knowledge of product, disease state and competitor landscape for assigned therapeutic area
• Respond to unsolicited requests for medical and scientific information regarding Gilead products and documents in the request handling system
• Research and collaborate with cross-functional colleagues to address complex requests.
• Create, update, and participate in review, quality check and approval of MI response documents
• Collaborate with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content
• Prepare and approve data on file to support response documents and complex requests
• Maintain document repository with routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Understand the needs and preferences of internal and external partners and customers
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• Participate and support MI booths at scientific congresses
• Serve as liaison for department specific training for new staff members, cross-functional colleagues and vendors, as required
• Contribute to departmental strategic initiatives by supporting key activities within the TA, including product launches, labeling updates, patient engagement etc.
• Execute and drive global MI initiatives and actions in a timely way to advance the provision of MI to improve patient care
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP
• Serve as department SME for one or more product(s) or TA
• Build and cultivate relationships with appropriate functions

Knowledge and Skills :

• Excellent written, verbal and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
• Ability to create and clearly communicate scientific data for different audiences,
• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment
• Ability to analyze and evaluate clinical, biomedical and scientific data
• Demonstrates Gileads core values and Leadership Commitments
• Has a strong attention to detail, excellent project management and problem-solving skills
• Previous experience with problem-solving and project management preferred

Basic Qualifications:

• Doctorate and 5+ years of relevant experience OR
• Masters and 8+ years of relevant experience OR
• Bachelors and 10+ years of relevant experience OR

Preferred Qualifications:

• Pharmacy, Nursing or Medical/ Life Sciences degree/advanced degree or equivalent
• Experience in MI preferred or comparable experience within a healthcare/clinical environment
• Experience in the pharmaceutical industry or a MI vendor
• Experience in conducting medical/promotional reviews

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045864

Full Time/Part Time Full-Time

Job Level Associate Director

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Associate Director Of Global Strategic Capabilities

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Overview

The Associate Director of Global Strategic Capabilities will be a key member of the Global Strategic Capabilities team that will lead the implementation and execution of key operational activities. The Associate Director is responsible for driving operational excellence and vendor oversight across regional and global initiatives. This role manages outsourced vendor relationships, ensures compliance with medical information procedures, and leads quality assurance efforts to uphold service standards. The Associate Director partners cross-functionally to support inspection readiness, streamline processes, and implement digital solutions. The role also plays a key part in developing metrics, enhancing system utilization, and identifying opportunities for efficiency and risk mitigation.

Job Responsibilities

• Manage the relationship between Gilead and outsourced medical information vendors, ensuring they have access to the appropriate information needed to provide excellent customer service (e.g. Gilead contacts, current product labeling, medical information content and other documents)
• Provide oversight of vendor performance through quality assurance programs, staff training, and process implementation to meet service standards.
• Develop and document operational processes while ensuring compliance of Medical Information procedures
• Work closely with medical information and vendors to ensure inspection readiness, including facilitating preparations for internal audits, responses to findings and implementation of process improvements.
• Identify opportunities for operational efficiencies and areas of risk, and develop solutions for improvement and risk reduction.
• Develop and implement a quality assurance plan for key Medical Information activities, including evaluation of product request reports, facilitating consistency of responses, and use of customer surveys
• Facilitate consistent use of Gilead medical information systems in alignment with global procedures and processes
• Develop and share metrics and KPI reports with stakeholders, supporting tracking of departmental deliverables and goals
• Lead or support digital projects in collaboration with cross-functional teams to enhance medical information deliverables.

Basic Qualifications

• PHD/PharmD and 5 years of relevant experience required OR
• Masters and 8 years of relevant experience required OR
• Bachelors and 10 years of relevant experience required

Preferred Qualifications

• Able to work under minimal direction
• Highly self-motivated and able to perform multiple tasks in a timely fashion.
• Excellent interpersonal, and verbal and written communication skills are required to effectively communicate, interact and work with cross functional teams.
• Demonstrated solid success in developing and maintaining good working relationships with internal colleagues and external contacts and influence cross-functionally at various levels.
• Ability to manage and lead multiple projects and change management initiatives in a fast-paced, cross-functional environment.
• Must have a customer focused mindset, strong attention to detail, excellent organization and problem-solving skills
• Strong knowledge of applicable country/regional legislation/regulations and legal requirements for the provision of medical information services, and for adverse event and product quality complaint reporting, in the pharmaceutical environment

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.

Associate Director - Medical Information Associate Director - Medical Information

1 day ago Be among the first 25 applicants

This range is provided by ECLARO. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$70.00/hr - $5.00/hr

Direct message the job poster from ECLARO

Job Title: Associate Director - Medical Information and Customer Engagement

Work Schedule: Weekdays, 8am-5pm

Position Summary

The Customer Engagement team aims to strategically design, develop, and evolve industry leading Customer Engagement and Medical Information call center capabilities while optimizing the customer experience. This role will be responsible for providing strategic and operational oversight for and execution of Medical Information Contact Center Strategy. Responsibilities include processes, standards, systems and services including managing the relationship with the Contact Center Partners covering US Medical Information, Global Escalations, WW SRD and Variant Content.

Key Responsibilities

1. Execute strategy for US customer engagement: Medical Information, Global Escalations, and Variant Content maintenance, and SRD management in alignment with WW Medical Excellence goals and objectives.

2. Actively engage with all key matrix functions at a Worldwide (WW)/Market level, e.g. WW Customer Engagement Center Leads, WW Medical/Med Comms, WW Field Medical & Medical Effectiveness Leads, Commercial Business Units, Safety, Quality and Business Solutions in order to:

- Provide an MI request service for managing complex questions in a timely and efficient manner

- Support the delivery of MI to HCPs and patients to meet Market and Regulatory needs

- Provide MI guidance and support for local or WW congress booths as required

3. Relationship lead with all key matrix functions at a US Commercial level in order to:

- Provide a customer information service for managing complex customer interactions in a timely and efficient manner

4. Execute Customer Engagement Center activities, such as:

- Oversight of Supplier Day to Day operations

- MI partner training

- Innovative approach towards service evolution while adhering to budgets and timelines

- Establishment, Maintenance and Adherence to processes and procedures ensuring operational effectiveness

- Delivery of performance reports and insights to stakeholders

- Inspection readiness and audit participation

- Telephony design

5. Monitor performance of MI partner against agreed procedures and quality metrics to ensure compliance. Identify continuous improvement opportunities and lead process improvement plans.

6. Oversight of team as it relates to:

i. Training Plans for existing and launch products and programs

ii. Quality oversight

iii. Content maintenance and creation to address needs

v. WW SRD & variant creation, maintenance & update

vi. Systems and solutions

Qualifications & Experience

5 years of experience in Medical Information, Contact Center, and Vendor Management.

Leadership skills

Excellence in communication; Ability to establish strong cross functional matrix relationships

Ability to critically analyze performance against quality measures, metrics, and process

Strong innovation, decision making and problem solving skills

Seniority level

• Seniority level Director

Employment type

• Employment type Contract

Job function

• Job function Business Development and Administrative
• Industries Biotechnology Research and Pharmaceutical Manufacturing

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Job Overview**
The Associate Director of Global Strategic Capabilities will be a key member of the Global Strategic Capabilities team that will lead the implementation and execution of key operational activities. The Associate Director is responsible for driving operational excellence and vendor oversight across regional and global initiatives. This role manages outsourced vendor relationships, ensures compliance with medical information procedures, and leads quality assurance efforts to uphold service standards. The Associate Director partners cross-functionally to support inspection readiness, streamline processes, and implement digital solutions. The role also plays a key part in developing metrics, enhancing system utilization, and identifying opportunities for efficiency and risk mitigation.
**Job Responsibilities** :
+ Manage the relationship between Gilead and outsourced medical information vendors, ensuring they have access to the appropriate information needed to provide excellent customer service (e.g. Gilead contacts, current product labeling, medical information content and other documents)
+ Provide oversight of vendor performance through quality assurance programs, staff training, and process implementation to meet service standards.
+ Develop and document operational processes while ensuring compliance of Medical Information procedures
+ Work closely with medical information and vendors to ensure inspection readiness, including facilitating preparations for internal audits, responses to findings and implementation of process improvements.
+ Identify opportunities for operational efficiencies and areas of risk, and develop solutions for
+ improvement and risk reduction
+ Develop and implement a quality assurance plan for key Medical Information activities, including evaluation of product request reports, facilitating consistency of responses, and use of customer surveys
+ Facilitate consistent use of Gilead medical information systems in alignment with
+ global procedures and processes
+ Develop and share metrics and KPI reports with stakeholders, supporting tracking of departmental deliverables and goals
+ Lead or support digital projects in collaboration with cross-functional teams to enhance medical information deliverables.
**Basic Qualifications:**
+ PHD/PharmD and 5 years of relevant experience required OR
+ Masters and 8 years of relevant experience required OR
+ Bachelors and 10 years of relevant experience required
**Preferred Qualifications:**
+ Able to work under minimal direction
+ Highly self-motivated and able to perform multiple tasks in a timely fashion.
+ Excellent interpersonal, and verbal and written communication skills are required to effectively communicate, interact and work with cross functional teams.
+ Demonstrated solid success in developing and maintaining good working relationships with internal colleagues and external contacts and influence cross-functionally at various levels.
+ Ability to manage and lead multiple projects and change management initiatives in a fast-paced, cross-functional environment.
+ Must have a customer focused mindset, strong attention to detail, excellent organization and problem-solving skills
+ Strong knowledge of applicable country/regional legislation/regulations and legal requirements for the provision of medical information services, and for adverse event and product quality complaint reporting, in the pharmaceutical environment
The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**OBJECTIVES** **:**
The Director, Medical Information & Review will work closely with the Sr Director, Medical Information & Review and assigned US Medical Team(s) to lead a high performing team responsible for medical information and medical review activities across a broad portfolio of products within a given therapeutic area. The Director will also support implementation of US Medical communication strategies and other scientific communication activities as identified.
**ACCOUNTABILITIES:**
+ Proactively manages medical information personnel and activities for assigned products in therapeutic area to include development of written and verbal responses, including clinical dossiers.
+ Responsible for ensuring team provides high-quality, balanced and timely medical information for multiple products upon the request of internal and external business partners, health care professionals (HCPs) and consumers. Serves as a technical and/or operational resource for direct reports.
+ Collaborates directly with medical strategy (Medical Director, Scientific Director) personnel in the development / execution of medical communications and research activities and leads operational and scientific projects aligned with company objectives and alliance partnerships for assigned therapeutic area.
+ Manage Medical Review personnel in the participation and contributions to cross-functional promotional review activities including: 1) providing strategic scientific consults on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinate the development and review and approval of clinical data on file to support promotional claims.
+ Leads the Medical Review process, procedures, and documentation of Non-Promotional Medical Review of Medical Materials in partnership with internal stakeholders. Medical Materials may include medical slides, medical training materials, medical education materials, white papers, publications, and other types of medical and scientific material.
+ Leads, manages, coaches and develops Medical Review personnel to support high performance, alignment with USM Medical Strategies, and support the delivery of high-quality product information, promotional product communications, and other medical and scientific communications. Assesses performance against identified Medical Review functional goals. Create, maintain and communicate metrics and key performance indicators to Leadership.
+ Maintains current and up to date knowledge on FDA Regulations and Guidance documents and enforcement action letters as applicable to promotional claims and shares implications with Medical Reviewers to enhance the team's knowledge, understanding, and awareness of best practices.
+ Supports the development of (Sr) Medical Information & Review Managers by supporting training activities to develop direct reports.
+ Assess new alliance partnerships for resource needs; develops appropriate joint Medical Review policies/processes; collaborates with Sr Director, Medical Information and Review and alliance partner in the development of policies/processes that reflect best practices and are in compliance with Takeda policies/processes.
+ Works closely with Scientific Communications Leadership Team to ensure standardization within the Medical Information and Review function of defined policies, SOPs, and best practices.
+ Ensures overall team is maintaining a comprehensive knowledge of therapeutic area, product(s), and health ecosystem developments by participating in relevant team and company meetings, attending scientific congresses, and a commitment to continued professional development.
**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:**
Required:
+ The qualified candidate will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry.
+ 3-5 years of managing people.
+ Excellent written and oral communication skills.
+ Significant understanding of issues in medical information and medical review.
Preferred:
+ Post-doctoral residency or fellowship, or sufficient applicable experience.
+ Significant experience and knowledge of clinical trial reports, data presentation, interpretation, and communications
**LICENSES/CERTIFICATIONS:**
+ None Required
**TRAVEL REQUIREMENTS:**
+ Willingness to travel to various meetings or client sites, including overnight trips. Some international or weekend travel may be required.
+ Requires approximately 5-20 % travel.
_The ideal candidate will be skilled not only in medical information and compliance but also in using AI tools to drive efficiency and innovation_
**MORE ABOUT US:**
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
#LI-Hybrid
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - MA - Hayden - 45-55
**U.S. Base Salary Range:**
$191,800.00 - $301,400.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - MA - Hayden - 45-55USA - MA - Lexington
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

**Work Schedule**
Flex Shifts 40 hrs/wk
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Within Medical Communications, we improve patient health by supplying medical information services to our customers, patients and healthcare providers. We engage with healthcare professionals, regulatory agencies and pharmaceutical customers to help them navigate regulatory and compliance requirements around the world. We manage medical information inquiries, document adverse events and product complaints, report product launches, prepare standard responses to inquiries and develop process improvements for customer implementation.
**Discover Impactful Work:**
Provides technical and medical information, and/or performs intake of adverse events/ product complaints with quality customer service. Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. The information provided will be given to a level in parallel with the individual's expertise, experience and training.
**A day in the Life:**
The working shift for this role is variable, rotating weekly between the hours of 8AM-8PM, 8 hours per day. Weekends, holidays, and on call shifts may be required. This is a hybrid position - 4 days per week working from home, 1 day per week from our Morrisville, NC or Wilmington, NC office.
- Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.
- Analyzes caller's questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.
- Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.
- Maintains thorough knowledge of project and corporate policies and procedures including client products, SOPs, protocols, GCPs, and applicable regulatory requirements.
- Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries. As needed, research medical literature and drafts responses for such inquiries.
**Keys to Success:**
Education
- Bachelor's degree in Nursing or equivalent and relevant formal academic / vocational qualification
- Active North Carolina RN license required or Nurse Licensure Compact (NLC) equivalency Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Experience
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
- Excellent verbal and written communication skills
- Excellent language skills (comprehension, speaking, reading and writing); Fluency skills in a second language may be required
- Proficient computer and keyboarding skills
- Good interpersonal skills
- Ability to work independently as well as part of a team.
- Ability to interpret client provided complex medical and technical information
- Organizational and time management skills
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/DisabilityAccess**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We are so glad you are interested in joining Sutter Health!
**Organization:**
SHSO-Sutter Health System Office-Valley
**Position Overview:**
*These positions are eligible to work from home from within the Sutter Health Northern California footprint.
The purpose of this position is to maximize the health of patients we serve at Sutter Health by aligning with and supporting hospitals, medical groups, divisions, and other clinical entities through the adoption, use, and optimization of digital technologies.
Will support enterprise strategic objectives, including quality, safety, growth, data and analytics, and innovation, through the use of digital technologies. Specifically, this role will oversee electronic health record (EHR) governance, prioritization, usability, and the clinical component of implementation, adoption, and optimization of informatics systems, including the electronic health records across all acute hospital settings. Responsible for transparency and end user satisfaction with Sutter EHR and related technologies, fostering a collaborative environment, empowering and encouraging digital interactions between physicians, nurses, staff, patients, and families while delivering intuitive and seamless access to quality healthcare.
Will partner across Sutter Health hospitals to create strategic medical informatics processes and priorities and build and deliver effective solutions that enhance patient care through the innovative use of technology, to drive the expansion and evolution of Sutter Health's acute digital footprint to achieve a digital competitive advantage.
**Job Description** :
**EDUCATION:**
+ Doctorate Degree: M.D. or D.O.
**CERTIFICATION & LICENSURE:**
+ Board certification in a medical specialty
**TYPICAL EXPERIENCE:**
+ 8 years recent relevant experience
**SKILLS AND KNOWLEDGE** **:**
+ Excellent understanding of and proven experience in utilizing EHR technology to positively transform hospital clinical practice by improving the quality of patient care, reducing costs and driving user satisfaction across the care continuum.
+ Working knowledge of the clinical information systems implementation process, use and support methodologies, regulatory requirements, strategic and tactical planning, project leadership/management and group dynamics.
+ Solid expertise in organizational change management concepts and strategies, including proactively using that body of knowledge to constructively transform the clinician and patient experience across the continuum of care.
+ Excellent understanding of evolving HIE/interoperability methods as well as related federal and state privacy and security regulations.
+ Demonstrated knowledge regarding potential impact of Stark, privacy and security laws and regulations on implementation and ongoing use of health IT systems.
+ Comprehensive knowledge of medical staff organization and department structures, physician/medical group practices, and clinical quality management practices.
+ Familiarity with the governance and economics of local Independent Physician Associations (IPAs) and medical foundations as well as a strong understanding of (legal) network clinical integration required.
+ Knowledgeable of healthcare trends (including healthcare reform), competitive intelligence, data analytics, big data and emerging technologies with the ability to integrate the information into actionable strategic and long-range informatics plans.
+ Strong working knowledge of the Epic healthcare software.
+ Understanding of and experience with Lean or other process improvement philosophies and methodologies desired.
+ Proven ability to evaluate an organization's IT systems; to design and implement electronic medical record (EMR)/EHR software and applications; to convert and analyze medical and health data; to ensure quality of care across multiple information systems; and to leverage medical and health data to improve services and daily operations.
+ Demonstrated ability to bridge the gap between patients, healthcare practitioners, enterprise leadership, and computer/data processing specialists, while maintaining and securing all patient records.
+ Proven ability to energize, mobilize, influence, and build accountability with a broad range of stakeholders through effective communication of vision, and the fostering of productive and supportive working relationships with internal and external constituencies.
+ Superior negotiating and problem solving skills with the proven ability to identify, research and analyze issues to offer effective solutions.
+ Excellent written and verbal communication skills, including the ability to translate complex technology and business concepts into lay terms and to articulately paint a vision of the desired end state.
+ Advanced level of computer competency in Microsoft Office Suite, including EMR/EHR/computerized physician order entry (CPOE) applications, health information exchanges (HIEs), as well as other relevant software for research and analysis.
**Job Shift:**
Days
**Schedule:**
Full Time
**Days of the Week:**
Monday - Friday
**Weekend Requirements:**
As Needed
**Benefits:**
Yes
**Unions:**
No
**Position Status:**
Exempt
**Weekly Hours:**
32
**Employee Status:**
Regular
Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans.
Pay Range is $166.58 to $266.52 / hour
_The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package._ __

Job Title: Senior Associate/Manager, Medical Information - Contractor
Location: Florham Park, New Jersey
Type: Contract
Compensation: $48 - $70 hourly (Depends on Experience and Education)
Contractor Work Model: Hybrid
Senior Associate/Manager, Medical Information - Contractor
Location: NJ-Florham Park: Hybrid (10days a month in the office)
Contract: 12mns
Overview
The Senior Associate/Manager, Medical Information (contractor) will be responsible for timely dissemination of current, accurate, and balanced medical information to healthcare professionals and customers through various communication channels. This role is responsible for developing and updating scientific medical information content and will support the lead medical reviewer in promotional and medical review teams. The Sr. Associate/Manager, Medical Information (contractor) also requires proficiency with drug information databases and systems, as well as an understanding of Medical Information processes and procedures.
Responsibilities
+ Ensures timely, accurate, balanced, and up-to-date scientific responses to medical inquiries from health care professionals and customers through various communication channels. Responsible for phone coverage as needed.
+ Create and update Medical Information (MI) scientific content, including Scientific Response Documents (SRDs) and FAQs.
+ Support the development and update of approved product AMCP Dossiers.
+ Shares customer inquiry trends through the creation of reports and presentations and disseminates to key internal stakeholders.
+ Participate in review of promotional, sales training, corporate communications, and scientific materials for medical accuracy in Promotional and Medical Review Committees.
+ Staffs Medical Information Booths at live scientific and medical meetings, as needed.
+ Participates in Medical Information, product, and disease state training to sales representatives, Medical Information Call Center and other vendors, as needed.
+ Recognize, capture, and report adverse events and product quality complaints.
+ Adhere to all applicable SOPs, policies, processes, and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information, and report AEs and PQCs.
Minimum Job Requirements
+ Advanced scientific degree (such as PharmD, PhD, MD, RN or equivalent) is preferred.
+ Minimum three (3) years in the pharmaceutical or healthcare-related industry. Medical Information experience preferred.
+ Strong scientific background with a deep understanding of medical and clinical concepts.
+ Strong medical writing experience.
+ Experience in therapeutic areas related to company's products preferred.
+ Understanding of legal and regulatory requirements related to the pharmaceutical industry and dissemination of medical information.
+ Capable of recognizing, capturing, and reporting adverse events and product quality complaints in compliance with regulatory standards.
Preferred Skills & Experience
+ Excellent technical writing and verbal communication skills, organizational skills, and attention to detail.
+ Demonstrated computer experience with MS Word, Excel, Access, and Outlook.
+ Ability to effectively prioritize, multi-task, and work independently to meet established deadlines.
+ Excellent project management skills
+ Analytical, solutions-oriented, and strategic-thinking skills
+ Highly self-motivated and able to manage multiple tasks in a timely fashion
+ Proven track record in working in a dynamic, cross-functional environment
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
#M-
#LI-
#DI-
Ref: #568-Clinical
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Tittle: Medical Information Replacement, Credit and Reimbursement Specialist
Location: Titusville, NJ, 08560
Duration: 09 Months
Pay Range: $(62.00 - 64.24)/hr on W2

Job Description:

• The client is looking for a skilled replacement, credit, and reimbursement Specialist to join their team in Titusville, NJ.
• The ideal candidate will be responsible for developing and implementing efficient processes for managing credits and reimbursements in compliance with regulatory requirements and government-funded programs, crucial for upcoming product launches.

Responsibilities:

• Develop and implement efficient processes for managing credits and reimbursements, ensuring alignment with applicable regulatory and government-funded program requirements.
• Collaborate with cross-functional teams to ensure that the credit and reimbursement strategies support our upcoming product launches.
• Analyze and understand wholesaler acquisition costs (WAC) to ensure our pricing strategies are competitive and compliant with government policies.
• Work closely with government agencies to facilitate the clearance of credits and reimbursement claims, maintaining effective communication and relationships.
• Stay updated on changes in regulations and government policies that impact reimbursement processes and communicate these to relevant stakeholders.
• Support the development of training materials and educate internal teams on best practices related to credits and reimbursements.
• Contribute to strategic planning for product launches with a focus on reimbursement and pricing strategies.

Qualifications:

• Bachelor's degree in healthcare, finance, business administration, or a related field.
• Proven experience working in credit and reimbursement roles, particularly with government agencies.
• Expertise in wholesaler acquisition costs (WAC) and its implications for product pricing and reimbursement strategies.
• Prior experience supporting a product launch, particularly in a regulated environment, is highly desirable.
• Ability to work independently, is detailed oriented, and must have excellent oral/written communication skills.
• Strong analytical skills with the ability to interpret complex regulations and policies.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment
• Experience and demonstrate proven technical and computer skills, including standard MS Office Software.
• Project Management experience preferred.
• Highly skilled in customer service.
• Ability to understand root cause of issues and effectively resolve customer inquiries which may involve extensive analysis and research.
• Demonstrated analytical, problem-solver with solid organizational, and interpersonal skills.
• Excellent time management, planning and organizational skills.
• Meet challenging goals and timelines; quickly changes plans when data or actions require it.
• Able to work in a fast-paced
• Experience in establishing new work instructions (WI) and/or standard operating procedures (SOP)
• Familiarity with government-funded programs and their reimbursement processes.
• Experience in developing and implementing innovative solutions to streamline reimbursement processes.
• Knowledge of pharmaceutical and healthcare industry trends and challenges.
• Secondary Responsibilities:
• Technology and Capabilities Support for GxP systems
• System Training Administrator
• UAT and Off-Script testing for GxP systems
• Project Coordination and Logistical Support o Documentation Review (SOPs, Training, etc.)
• Training and Processes Support
• Support training and compliance programs and process meetings/updates.
• Perform training content reviews, training updates and suggest opportunities for training improvements/content.
• Sharing knowledge and guidance regarding training and compliance trends.
• Settlements
• Process customer requests for product replacements, credits and refunds, including contacting customers (HealthCare Professionals or Consumers) via multiple channels (Genesys).
• Documenting in CRM system (i.e. Client.com).
• Administrative Support:
• Process hardcopy mail.
• Administrative duties as needed.
• Preferred Requirements:
• Knowledge and support of client IT tools including, but not limited to:
• Client.com/iConnect/Genesys Cloud
• Knowledge of Contact Center processes and policies o Knowledge of Medical Information processes and policies
• Knowledge of Pharmaceutical Industry standards and compliance qualifications
• Structured environment with a team approach.