About the role:
Understand various roles, processes and industry standards involved in the US Medical Affairs, US Commercial Regulatory and Global Regulatory Labeling areas at Ipsen Biopharmaceuticals, Inc.
Assist in the creation of medical information response documents
Be an active contributor to the team to develop/launch medical strategies within the Medical Affairs Teams
Contribute to the review of promotional and medical materials
Work closely with Medical Affairs team to develop training and scientific education for internal and external stakeholders
Collaborate with cross-functional teams (regulatory, marketing, sales, legal, clinical development) to provide and communicate the most up to date scientific information as a subject matter expert
Learn how to develop strategic scientific communication plans in a cross-functional manner
Partner with Medical Directors /Health Economics Directors to develop scientific materials that align with the scientific communication materials that align with the scientific communication plan (e.g. manuscripts, abstracts, posters, slide decks).
Learn the basic tenants of US promotional labeling regulations and apply to the regulatory review of marketing materials
Support continuous improvement of US promotional review process through evaluation and revising Work Instruction and Standard Operating Procedure documents
Interpret and summarize for US affiliate colleagues new FDA Guidance Documents identifying impact to the company
Liaise with commercial stakeholders and compliance functional partners to help identify areas of vulnerability and offer mitigation strategies
Conduct competitor regulatory intelligence analysis, liaise with functional partners and present opportunities for objection handling, competitor complaint and/or revising promotional claims
Evaluate and revise promotional regulatory internal training documents · Work cross functionally to establish and maintain core company data sheet for IPSEN products
Manage required labelling updates, proofreading, and version control
Manage quality control over core company data sheet labelling process
Maintain tools that support coordination with other functions (e.g., Product distribution lists)
Communicate and disseminate newly approved core company data sheet to internal stakeholders
Maintain and catalogue all labelling materials in accordance with company policies, procedures, and technologies.
Gain experience and skills to be a successful member of a Medical or Regulatory Affairs department in the biotech industry.
Ipsen Contact Email: PharmDFellowship.USA@ipsen.com