ProClinical is seeking a Director, Advertising and Promotion RA, for a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. This individual independently represents the Regulatory compliance voice on the Copy Review Board and acts as an internal expert to advise on the FDA and global health authority requirements for pre-and post-approval promotional materials, disease state education, field training materials, and external communications materials, working closely with all stakeholders to reach consensus on approved messages and materials.
- Provides regulatory direction in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications for use in the US and global markets
- Maintains a thorough understanding of OPDP and global health authority requirements as well as a keen awareness of enforcement trends and is confident in their analysis and application to compliance assessments
- Prepares presentations and trains other departments and outside speakers
- Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in medical and marketing communications and activities
- Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during promotional and scientific medical reviews
- Serves as the primary point of contact with the FDA Office of Prescription Drug Promotion on all matters including subpart H clearance as applicable
- Member on project teams and regulatory sub-teams, as appropriate
- Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of promotional materials for marketed products.
Skills and Requirements:
- Ph.D. or Pharm. D preferred.
- BS or MS in scientific discipline or equivalent required.
- Advanced degree and/or RAC certification preferred
- 10+ years of regulatory affairs experience with drugs and/or biologics
- At least 8 years' experience in pre-and post-market promotional development and review
- Extensive knowledge of global regulations, guidance documents, and initiatives related to post-marketing product maintenance and compliance
- Excellent interpersonal skills and written and oral communications skills
- Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
- Must be able to innovate, analyse, and solve problems with minimal supervisory input
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mike Froggatt on +1 646 768 9727 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.