Account Management - Medical Monitor

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 :