Medical Monitor

Position: Medical Monitor 58174-1Location: Lawrence Township NJ 08648Duration: 6 months (possibility of extension for the right candidate depending on performance)Pay rate: $75/ hour on W2 50% on-site. 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.

Position Summary:• The Established Brands medical scientist-contractor is responsible for the medical oversight of activities for brands in the late stages of the life cycle and those that 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, and 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's operating philosophy, and company shared values and operate within company policies and procedures and appropriate regulations.• Strong ability to operate effectively within highly matrixed and collaborative environments:• 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 products preferably with experience in the pharmaceutical industry and post-marketing safety.• Ability to provide input to cross-disciplinary matrix teams, and 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.