Associate Manager, Regulatory Affairs, Advertising & Promotion

Gilead Sciences, Inc. Foster City , CA 94404

Posted 2 months ago

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Associate Manager, Regulatory Affairs, Advertising and Promotion

Specific Responsibilities and Skills for Position:

The Associate Manager in Regulatory Affairs, Advertising and Promotions is responsible for providing strategic support and operational leadership in the area of advertising and promotion primarily pertaining to US marketing activities and products. This role will support the HIV therapeutic area, and may additionally support other therapeutic areas (Liver Disease, Oncology, Inflammation, and/or Cardio-Pulmonary) as needed based on the individual candidate and related business priorities.

The Associate Manager will report to senior personnel in Regulatory Affairs, Advertising and Promotion, and will review promotional materials to assess for compliance with the applicable regulations and guidance documents. This position must be capable of representing the commercial regulatory perspective at and chairing or assisting with chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct. The Associate Manager will additionally oversee the submission of branded materials for assigned products to FDA on or before the date of first use.

Essential Duties and Job Functions:

This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance. Primary responsibilities include the review and approval of promotional materials for Gilead marketed products and certain non-promotional materials.

Additionally, responsibilities may include communicating the commercial regulatory perspective and rationale at regulatory project team meetings, brand team meetings and, as needed, providing training to cross-functional members of the PRC. The Associate Manager will also be responsible for reviewing enforcement letters, keeping current with industry changes and FDA Guidances relating to advertising and promotion, and continuing efforts to evaluate processes within Regulatory Affairs relating to the promotion of Gilead products in the United States.

The Associate Manager will maintain up to date knowledge of regulatory requirements and communicate changes in regulatory information to project teams in a timely manner. The Associate Manager may initiate and/or contribute to local process improvements for activities that relate to promotion of Gilead products. Under the supervision of senior Regulatory Affairs personnel, the Associate Manager independently plans, schedules and arranges own activities.


Knowledge, Experience and

Skills:

Typically requires a BA degree and 1-2 years of experience in Regulatory promotional material review for prescription drug and/or biologic products. An advanced degree is desirable but not required.

Excellent verbal and written communication skills and interpersonal skills are required. Must have a working knowledge of regulatory requirements associated with advertising and promotion of prescription drug and/or biologic products. Must be capable of managing negotiations with cross-functional team members.

Must be able to independently manage and prioritize work with no immediate direction from senior Regulatory Affairs personnel. The position will be recognized as a knowledgeable resource for regulatory advice on promotional initiatives in other departments.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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 log onto your Internal Career Site to apply for this job.



See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Regulatory Affairs Advertising & Promotion

Gilead Sciences, Inc.

Posted 1 week ago

VIEW JOBS 12/2/2018 12:00:00 AM 2019-03-02T00:00 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Specific Responsibilities and Skills for Position: The Manager in Regulatory Affairs, Advertising and Promotions is responsible for providing strategic support and operational leadership in the area of advertising and promotion primarily pertaining to US marketing activities and products. This role will support the HIV therapeutic area, and may additionally support other therapeutic areas (Liver Disease, Oncology, Inflammation, and/or Cardio-Pulmonary) as needed based on the individual candidate and related business priorities. The Manager will report to senior personnel in Regulatory Affairs, Advertising and Promotion, and will review promotional materials to assess for compliance with the applicable regulations and guidance documents. This position must be capable of representing the commercial regulatory perspective at and chairing or assisting with chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct. The Manager will additionally oversee the submission of branded materials for assigned products to FDA on or before the date of first use. Essential Duties and Job Functions: This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance. Primary responsibilities include the review and approval of promotional materials for Gilead marketed products and certain non-promotional materials. Additionally, responsibilities may include communicating the commercial regulatory perspective and rationale at regulatory project team meetings, brand team meetings and, as needed, providing training to cross-functional members of the PRC. The Manager will also be responsible for reviewing enforcement letters, keeping current with industry changes and FDA Guidances relating to advertising and promotion, and continuing efforts to evaluate processes within Regulatory Affairs relating to the promotion of Gilead products in the United States. The Manager will maintain up to date knowledge of regulatory requirements and communicate changes in regulatory information to project teams in a timely manner. The Manager may initiate and/or contribute to local process improvements for activities that relate to promotion of Gilead products. Under the supervision of senior Regulatory Affairs personnel, the Manager independently plans, schedules and arranges own activities. Knowledge, Experience and Skills: Typically requires a BA degree and 1-2 years of experience in Regulatory promotional material review for prescription drug and/or biologic products. An advanced degree is desirable but not required. Excellent verbal and written communication skills and interpersonal skills are required. Must have a working knowledge of regulatory requirements associated with advertising and promotion of prescription drug and/or biologic products. Must be capable of managing negotiations with cross-functional team members. Must be able to independently manage and prioritize work with no immediate direction from senior Regulatory Affairs personnel. The position will be recognized as a knowledgeable resource for regulatory advice on promotional initiatives in other departments. For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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 log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. Foster City CA

Associate Manager, Regulatory Affairs, Advertising & Promotion

Gilead Sciences, Inc.