Medical Doctor - Princeton, United States - Net2Source Inc.

Description

Job Title: Medical Monitor

Location: Princeton Pike, NJ

Duration: 6+ months (Contract)

Pay Rate: $73-83/hr on W2

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 BMS 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.

Thanks

Sajid Sarkar

Pharma Recruiter

Ext.329

270 Davidson Ave Suite 704