Job Details
Position Summary:
The Established Brands medical scientist-contractor is responsible for the medical oversight of activities for brands in late stages of life cycle and those which have undergone Loss-of-Exclusivity
Key Responsibilities:
- Lead medical input for brand cross-functional teams for assigned products.
- Provide medical input to patient safety monitoring of the brand and available literature findings, propose labeling recommendations based on signal detection activities and pharmacovigilance findings.
- Provide Medical Assessments of Risk/Benefit of assigned products regarding new indications, safety or stability issues, medical necessity/sensitivity assessments or other actions that require reappraisal of the product Risk/Benefit.
- Provide medical input for regulatory requirements, including Response to Health Authorities queries and support for registration renewals and label periodic reviews.
- Provide medical support to the Company Core Data Sheet content review and development.
- Provide medical evaluation and appropriate communications to additional documents and activities such as: Dear Health Care Professional letters, Clinical Overview for Type II variation, Periodic Benefit-Risk Evaluation regulatory document submissions and coordinate expert reports.
- Compliance Support delivery of medical affairs compliance needs for the assigned portfolio as appropriate.
- Position Competencies:
- Demonstrate ability to apply Client operating philosophy, company shared values and operate within company policies and procedures and appropriate regulations.
- Strong ability to operate effectively within highly matrixed and collaborative environment:
- o Partner with local market organizations as appropriate for medical deliverables and portfolio functions.
- o Collaborate with key cross-functional partners, Global Regulatory, Global Labeling, Patient Safety, Quality & Compliance.
- Knowledgeable and skilled in medicine and pharmaceutical product preferably with experience in pharmaceutical industry and post-marketing safety.
- Ability to provide input to cross-disciplinary matrix teams, promote collegiality and teamwork among team members.
- Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues.
- Familiarity with regulatory guidelines.
- Excellent oral and written communication, interpersonal and time management skills.
- Demonstrate flexibility, open mindedness and adaptability in a rapidly changing environment.
Qualifications: - MD or Equivalent required
- Board certification and medical specialty are highly preferred
- 2-4+ years in clinical practice
- 1-2+ years of pharmaceutical industry experience required with 5+ years preferred
- 1-2+ years of clinical safety experience strongly preferred, with experience with pharmacovigilance-safety
- Experience in multi-brand experience would be an advantage.