GSK

Manager, Regulatory Advertising and Promotion Policy

Employer
GSK
Location
Research Triangle Park, North Carolina; Waltham, Massachusetts; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Posted
January 06 2021
Ref
275509
Organization Type
Pharma
Job Type
Manager
Are you interested in using your specialized knowledge of FDA regulations to provide sound regulatory advice on the advertising and promotion of prescription drug products and biologics in an effort to competitively position products for GSK? If so, the Associate Director/Manager role in Regulatory Advertising & Promotion Policy may be ideal for you.

As a Regulatory Advertising & Promotion Policy Associate Director/Manager, you will:

Serve as internal expert on FDA regulations governing the promotion of assigned products:
  • Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance
  • Provide leadership on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
  • Monitor OPDP activities and actions, assesses impact and communicates information to stakeholders
  • Analyze whether non-clinical promotional claims are supported
  • Ensure application of key learnings across assigned brands
  • Recommend appropriate actions for proposed advertising and promotion with established precedent
  • Influence and participate on multiple cross-functional US Pharma and R&D teams with junior and some senior membership
  • Advise on the development of US labeling to ensure support for anticipated promotional messages and claims
  • Understand labeling for assigned GSK and competitor products
  • Ensuring that changes in US prescribing information are reflected in current promotion and advertising


Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers for assigned products:
  • Establish and nurture a productive, transparent relationship with OPDP to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions.
  • Manage interaction with OPDP including response to regulatory inquiries or enforcement actions and discussion with OPDP staff on requested changes
  • Develop appropriate and proactive communications with OPDP reviewers that help ensure expedient and efficient review of regulatory submissions
  • Ensure all advisory submissions to OPDP are complete, accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review


This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
  • Provide Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the review and development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy
  • Serve as internal expert on FDA regulations governing the promotion of assigned products
  • Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers for assigned products
  • Manage interaction with OPDP, including response to regulatory inquiries, preparation of complete, accurate, high quality submissions for advisory comments, and as needed discussion with OPDP staff
  • Participate in company working groups on advertising and promotion standards and guidelines
  • Ensure that changes in US prescribing information are reflected in current promotion and advertising
  • Understanding of labeling for assigned GSK and competitor products
  • Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance
  • Demonstrate leadership as the Regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
  • Monitor OPDP research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders
  • Influential member of multiple cross-functional US Pharma and R&D teams


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Undergraduate degree in a biological or healthcare scientific discipline
  • Experience in pharmaceutical/biologics regulatory, or scientific disciplines
  • Experience in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
  • Demonstrated ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment.


Preferred Qualifications:

If you have the following characteristics it would be a plus:
  • Advanced degree in biological or healthcare scientific discipline
  • Demonstrated history of successful interactions with FDA reviewers at OPDP
  • Understanding of product development process, including clinical trial design, and labeling development process


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*LI-GSK

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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