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: • 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.