Manager, Safety Analysis Scientist

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

About Oncology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-080033

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Manager, Safety Analysis Scientist, located in High Wycombe, UK. This is a hybrid position that requires you to be on site three days a week.

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:

Required:

• 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.