HireDiversity

Titusville, NJ, US

Global Medical Safety Physician, Established Products, Director-4778120501

Description

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Global Medical Safety Physician, Established Products, Director. This position can be based in Horsham, PA or Titusville, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Global Medical Safety (GMS) Physician, Director, will report to and assist the Therapeutic Area (TA) Safety Head, Established Products (EP) in the safety assessment of the full portfolio of established products.

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 Johnson & Johnson pharmaceutical products.

This physician will assist the existing physicians already assigned to EPs in carrying out the following: data review and analysis, ADR determination, CCDS updates, and ad hoc responses to Health Authority queries. Responsibilities also include reviewing and providing input on key regulatory or clinical documents (CSRs, protocols, PSURs etc.) as appropriate to ensure these key safety documents are of high medical and scientific quality. This physician will also provide safety support to new products transitioning into the EP franchise. Responsibilities will also include participation on process improvement work streams to bring efficiency and ensure compliance.

Qualifications


An MD (or equivalent medical degree) is required, as is Board Certification (or relevant national qualifications ex-US) in a relevant medical discipline. At least 5 years of post-residency/fellowship experience is required; either in clinical practice, academia, clinical research, or drug safety from the Pharmaceutical, Biotech or relevant industry experience is required. At least 1 year of postmarketing safety or related industry experience is also required, including experience preparing PSURs.

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, as is the ability to work effectively as a member of a multidisciplinary team. 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. Candidates 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.

This position may require travel of up to 10% in support of business needs.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)