MANAGER, SAFETY ANALYSIS SCIENTIST

Johnson & Johnson Innovative Medicine, is recruiting for a Manager, Safety Analysis Scientist to be located in High Wycombe, United Kingdom or Lagoas Park Office, Portugal.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
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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 the need arises.
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 Director, SAS 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.
Principal responsibilities Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other team members as necessary, data retrieval, data analysis, report writing, and report revision.
Ensure high quality safety evaluations and reports with minimal-to-moderate comments from team members 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.
.
preparing and presenting data, compiling meeting minutes, updating signal tracking information).
Lead proactive safety data reviews.
Qualifications Education & Experience Requirements 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.
Required Skills.
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.
Ability to interpret and present complex data to determine benefit-risk impact.
Excellent English verbal and written communication skills.
Ability to effectively interact with team members, including business partners.
Ability to work in a cross-functional team environment, proven leadership skills.
Ability to plan work to meet timelines and effectively balance multiple priorities.
Proficiency in Microsoft applications (e.
.
Word, Excel, and PowerPoint).
Ability to influence, negotiate and connect with both internal and external customers.
We are pleased to announce that from mid-, our offices in Wokingham and High Wycombe will move into a modern, state-of-the-art Johnson & Johnson office in central Maidenhead, conveniently situated next to the train station.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
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.