Manager, Safety Analysis Scientist Full-time

Manager, Safety Analysis Scientist

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Location: High Wycombe, Buckinghamshire, United Kingdom

Job Function: Product Safety

Job Sub Function: Product Safety Risk Management

Job Category: Scientific/Technology

Purpose:

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 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.

You will be responsible for:

• 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.

Qualifications / Requirements:

Education:

• Bachelor's Degree Required: Healthcare-related or Biomedical Science (9+ years of industry experience or equivalent).
• Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).

Experience:

• Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
• Medical writing or PV experience.
• 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 stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively handle multiple priorities.
• Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint).
• Ability to influence, negotiate, and communicate with both internal and external customers.

Preferred:

• Clinical experience.

Required Skills: Preferred Skills:

Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing