Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Manager Safety Analysis Scientist (SAS) work in Horsham, PA., Raritan, NJ., or Titusville, NJ., High Wycombe, UK.
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 Manager Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Manager SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development.
The Manager SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required.
The Manager SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.
The Manager SAS will have in-depth product knowledge, will serve as product point of contact, and will provide mentoring to, and oversight of deliverables prepared by, other team members as needed (for complex reports).
The Manager SAS will function independently, or with moderate guidance from the Therapeutic Area Lead (TAL), be able to link discussions to content, and deliver quality results with minimal guidance. The Manager SAS will build alliances and be able to influence other safety partners to shape decisions/outcomes. Other responsibilities include:
- Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
- Ensure high quality safety evaluations and reports with minimal-to-moderate comments from stakeholders and minimal-to-moderate revisions required.
- Provide support to AD SASs for novel projects without defined processes.
- Provide input and review to key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Lead proactive safety data reviews, if applicable and form a safety position across GMS which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Contribute to cross-functional training of relevant stakeholders.
- Mentor other SASs on activities within the role.
- Participate in department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies.
- Assist in the creation, review and implementation of controlled documents and other related tools.
- Support audits/inspections.
- The primary decision-making responsibility centers around applying leadership and a thorough understanding of safety data analysis and interpretation, international pharmacovigilance regulations, and company procedures.
- The Manager SAS will function independently and must be able to recognize potential safety issues and escalate as appropriate, think strategically with respect to data interpretation, and understand the nature of adverse drug reactions and complex associations. In addition, the Manager SAS will need to understand stakeholder/customer needs, be able to build alliances and influence other groups, have a high level of flexibility and attention to detail, be able to handle a large workload efficiently, and be able to complete safety evaluations and other related functions with a moderate degree of efficiency.
- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (9+ years industry experience or equivalent).
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).
- Medical writing or PV experience required.
- Clinical experience preferred.
- Requires working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Ability to understand and analyze complex medical-scientific data from a broad range of sources required
- Ability to interpret and present complex data to determine benefit-risk impact required
- Excellent English verbal and written communication skills required
- Ability to effectively interact with stakeholders, including business partners preferred
- Ability to work in a matrix environment, proven leadership skills preferred
- Ability to plan work to meet deadlines and effectively handle multiple priorities preferred
- Proficiency in Microsoft Word, Excel, and PowerPoint required
- Ability to influence, negotiate and communicate with both internal and external customers desirable.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)