Associate Director, Safety Analysis Scientist

Description

At [Employer hidden — sign up to reveal], 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. Learn more at jnj.com.

As guided by Our Credo, [Employer hidden — sign up to reveal] 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 [Employer hidden — sign up to reveal], we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Product Safety

Job Sub Function: Product Safety Risk Management

Job Category: Scientific/Technology

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

About Innovative Medicine & 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 for finding treatments and cures. 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 jnj.com/innovative-medicine.

Purpose

The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD 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 AD 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.

Responsibilities

• Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders, data retrieval, data analysis, report writing, and report revision.
• Ensure high quality safety evaluations and reports with minimal comments from stakeholders.
• 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 and form a safety position across Global Medical Safety (GMS).
• Provide support for Health Authority interactions regarding safety and risk management.
• Assume responsibility for novel projects, create value and innovate without defined processes.
• Lead cross-functional training of relevant stakeholders.
• Act as product or process Subject Matter Expert (SME) for audits/inspections.
• Participate in or lead department and/or cross-functional initiatives.
• Explore innovative ways of presenting data, preparing reports, and improving efficiencies.
• Assist Directors in the creation, review and implementation of controlled documents.
• Management of unscheduled reports within the Aggregate Report Calendar.
• Management activities within smaller Therapeutic Areas.
• Line-management of contractor positions within the team, as applicable.
• Act as backup to TAL as needed.
• Oversight of deliverables by other team members.

Qualifications

Education:

• Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).
• Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent).

Required Experience:

• Medical writing or Pharmacovigilance (PV) experience required.
• 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.
• Excellent English verbal and written communication skills.
• Ability to work in a matrix environment, proven leadership skills.
• Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).

Preferred:

• Clinical experience preferred.
• Oncology experience preferred.

Required Skills: Clinical Operations, Compliance Management, Compliance Risk, Data Reporting, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility, Technical Writing.

How to Apply

Apply via the [Employer hidden — sign up to reveal] careers portal using requisition number R-061721. For questions, contact [Employer hidden — sign up to reveal].