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Medical Monitor

5 months ago

Lawrence Township, United States Tech Tammina Full time
Job Title: Medical Monitor
Location: Lawrence Township, NJ
Duration: 1 Year

Job Description:
  • 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
  • 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.

Qualifications:
  • 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:
  • Partner with local market organizations as appropriate for medical deliverables and portfolio functions.
  • 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.
  • 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.