Website Johnson & Johnson
This Jobsfunter Listing is about Johnson Johnson in High Wycombe, England, United Kingdom 2022
About the job
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. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Janssen Research & Development, L.L.C., is recruiting for a Manager Safety Analysis Scientist (SAS), based at Raritan NJ, Horsham PA, Titusville NJ, United Kingdom, Netherland, Belgium and Switzerland. Candidates seeking a remote role, working within the US East Coast time zone, may also be considered for the role.
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 content 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.
- Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other collaborators as necessary, data retrieval, data analysis, report writing, and report revision.
- Ensure high quality safety evaluations and reports with minimal-to-moderate comments from collaborators 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 used 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 team members.
- Mentor other SASs on activities within the role.
- Participate in department and/or cross-functional initiatives and explore innovative ways of conveying data, preparing reports, and improving efficiencies.
- Assist in the creation, review and implementation of controlled documents and other related tools.
- Support audits/inspections.
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.
- Solid understanding 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 peers, including business partners
- Ability to work in a cross-functional team environment, proven leadership skills
- Ability to plan work and effectively balance multiple priorities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to influence, negotiate and communicate with both internal and external customers.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
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.
United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Netherlands
Janssen Research & Development, LLC (6084)
Company: Johnson & Johnson
Vacancy Type: Full-time
Job Location: High Wycombe, England, United Kingdom
Application Deadline: N/A