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Training & Development Specialist
4 months 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 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.
Position Competencies:
Demonstrate ability to apply Client operating philosophy, company shared values and operate within company policies and procedures and appropriate regulations.
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.
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