Manager, Safety Analysis Scientist
Johnson & Johnson
High Wycombe, United Kingdom
3d ago

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Safety Analysis Scientist (SAS).

This position can be located in Horsham, PA; Raritan, NJ; Titusville, NJ; or High Wycombe, United Kingdom, Beerse, Belgium OR Remote locations within North America and Europe may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Learn more at and follow us JanssenGlobal Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

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.

Principal responsibilities

  • 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.
  • Contribute to cross-functional training of relevant stakeholders.
  • Mentor other SASs on activities within the role.
  • Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
  • 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

    A minimum of a Bachelor’s degree is required, preferably in Biomedical Science or Healthcare related discipline. An Advanced degree (Master’s, PhD, etc) in Biomedical Science or Healthcare related discipline is preferred.

    A minimum of 9 or more years of related industry experience with a Bachelor’s degree or a minimum of 6 or more years of related industry experience with an advanced degree is required.

    Medical writing or Pharmacovigilance (PV) experience is required.

    Clinical experience preferred.

    Experience in the Immunology or Infectious Diseases is preferred

    Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required.

    Ability to understand and analyze complex medical-scientific data from a broad range of sources is required.

    Ability to interpret and present complex data to determine benefit-risk impact is required.

    Excellent English verbal and written communication skills is required.

    Ability to effectively interact with stakeholders, including business partners is required.

    Ability to work in a matrix environment, proven leadership skills is required.

    Ability to plan work to meet deadlines and effectively handle multiple priorities is required.

    Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint) is required.

    Ability to influence, negotiate and communicate with both internal and external customers is required.

    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.

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