Global Medical Safety Physician, Oncology (Director) Job in New Jersey US
J&J Pharmaceutical R&D Inc., a member of the J&J family of companies, is actively recruiting for a Global Medical Safety (GMS) Physician, Oncology (Director).
The Global Medical Safety (GMS) Physician, Director will report to and assist the Therapeutic Area (TA) Head in the safety assessment of assigned drugs that are marketed and/or in clinical development.
This role in the Global Medical Safety organization will assist the Oncology TA Safety Head, physicians, and scientists support small and large molecule oncology products that are in development and/or marketed, including VELCADE.
The GMS Physician will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities, Prescribers and/or Patients.
In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of J&J pharmaceutical products.
Chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities, as well as other activities related to managing the safety profile of assigned products.
Participate in regulatory authority interactions regarding safety and risk management, both written and verbal.
Provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents (CSRs, protocols, PSURs etc.) are of high medical and scientific quality.
Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Participate on due diligence teams to evaluate L&A opportunities.
QualificationsBoard Certification, (or relevant national qualifications ex-US) in a relevant medical discipline is preferred.
At least 5 years of drug safety related experience from within the Pharmaceutical, Biotech or relevant industry including Health Authorities.
.
Knowledge of global safety regulations, principles of drug development and safety assessment of drugs both on the market and in development is preferred.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is preferred.
Clinical trials experience is preferred.
Ability to influence, negotiate and communicate with both internal and external customers is key. Ability to plan work to meet deadlines and effectively handle multiple priorities is required.
Excellent verbal and written communication skills, including formal presentation skills are required.
Must be fluent in written and spoken English.
Written skills as evidenced by publication and journal articles are preferred.
Working knowledge of the use of Microsoft suite of software products including Excel, and Word is required.
Proficiency in PowerPoint is required.
Travel of up to 10% is required.
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