Manager, Safety Analysis Scientist - 2406202360W

Description

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.

• 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 Associate Director (AD) SASs for novel projects without defined processes.

• Provide input and review of 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 Global Medical

Safety (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

Minimum Qualification

• 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 Pharmacovigilance (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 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

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.

Primary Location NA-US-Pennsylvania-Horsham

Organization Janssen Research & Development, LLC (6084)

Job Function Product Safety Risk Management

Req ID: 2406202360W