Director Medical Safety Officer Oncology J&J
Overview
Lead medical safety for innovative medicine products in Titusville NJ Raritan NJ Horsham PA. Drive proactive risk management and benefit/risk assessments. Shape global safety strategy and drive cross-functional collaboration.
What You'll Do11
- 1Strategically lead Safety Management Teams for assigned products
- 2Conduct safety surveillance and manage risk profiles including RMP and REMS
- 3Provide medical expertise as GMS representative on Compound Development and Clinical Teams
- 4Influence clinical protocols to mitigate patient impact through active participation
- 5Contribute to key regulatory documents such as Risk Management Plans and Clinical Study Reports
- 6Communicate safety findings to GMS Leadership Team, CMO, and Medical Safety Council
- 7Develop and implement new SOPs and guidelines for safety assessment processes
- 8Lead due diligence teams evaluating licensing and acquisition opportunities
- 9Provide medical oversight to contractors and non-physician staff preparing safety evaluations
- 10Collaborate across GMS teams to harmonize safety data collection and assessment practices
- 11Plan work to meet deadlines while handling multiple priorities
Requirements10
- 1Physician with 2-5 years pharmacovigilance experience or equivalent relevant background
- 2Board certification preferred with demonstrated clinical medicine expertise
- 3Medical specialization preferred and at least 1 year clinical practice experience
- 4Expertise in drug development clinical trial methodology and global safety regulations
- 5Ability to influence stakeholders and present findings in written and oral formats
- 6Proficiency in Good Clinical Practices and Pharmacovigilance regulatory requirements
- 7Strategic thinking with global mindset and ability to see business implications
- 8Experience with Health Authority presentations and regulatory filing contributions
- 9Strong communication skills for internal and external stakeholder engagement
- 10Fluency in English and proficiency with Word and PowerPoint
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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