Regulatory Advertising and Promotion Policy, Manager
- Undergraduate degree in a biological, legal or health care scientific discipline
- 3-5 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
- 1-2 years in the review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents.
- Be able to demonstrate strategic and analytical thinking
- Demonstrated success in constructive contributions to multidiscipline matrix teams.
- Demonstrated ability to facilitate appropriate team decisions.
- Advanced degree in biological or health care scientific discipline
- 5 -10 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
- 3-5 years in the review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents
- Demonstrable history of successful interactions with FDA reviewers at OPDP.
- Understanding of product development process, including clinical trial design, and labeling development process
- Proven ability to multi task and excel in cross functional settings and to manage multiple projects in a fast paced environment
This role is equivalent to an Associate Director.
- Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance
- 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
- 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, preparation of complete, accurate, high quality submissions for advisory comments, and discussion with OPDP staff on requested changes.
- Appropriate, proactive communications with OPDP reviewers that help ensure expedient and efficient review of regulatory submissions
- Leadership on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
- Ensure all submissions to OPDP are complete, accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
- Monitor OPDP activities and actions, assesses impact and communicates information to stakeholders.
- Advise on the development of US labeling to ensure support for anticipated promotional messages and claims.
- Influential member of multiple cross-functional US Pharma and R&D teams with junior and some senior membership
- 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
- Provides operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion for the US market (for minor company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy
- Effective communications with reviewers within OPDP that expedite resolution of issues relating to assigned products
- Understanding of labeling for assigned GSK and competitor products
- Ensure that changes in US prescribing information are reflected in current promotion and advertising
- Participate in company working groups on advertising and promotion standards and guidelines
- Maintain a quality system to support advertising and promotion regulatory requirements
Deadline for Applications: 28th September 2017
You may apply for this position online by selecting the Apply now button.
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