Account Management
4 weeks ago
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 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.
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