At a Glance
- Tasks: Lead safety evaluations and collaborate on innovative healthcare solutions.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities to lead and innovate.
- Why this job: Make a real impact in the fight against cancer and improve patient outcomes.
- Qualifications: Experience in medical writing or pharmacovigilance and strong analytical skills.
The predicted salary is between 60000 - 80000 £ per year.
At Johnson & Johnson, 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.
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.
About Oncology: Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities for 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.
This is a hybrid position that requires you to be on site three days a week.
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.
The AD SAS will assist the Medical Safety Officer (MSO) with activities related to the SMT and with contributions to key safety and clinical documents. The AD SAS will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports). The AD SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD SAS will quickly build alliances and be able to independently influence other safety partners to shape strong 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 comments from stakeholders and minimal revisions required.
- 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.
- Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from Directors (i.e., SAS TAL) for complex projects.
- 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 within the programs they own.
- Assist Directors in the creation, review and implementation of controlled documents and other related tools.
- Management of unscheduled reports within the Aggregate Report Calendar.
- Management activities within smaller Therapeutic Areas, as applicable.
- Line‑management of contractor positions within the team, as applicable.
- Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
- Oversight of deliverables by other team members (e.g., complex reports), as needed.
Qualifications / Requirements
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).
Experience
Required
- 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 from a broad range of disciplines.
- 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 independently influence, negotiate and communicate with both internal and external customers.
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.
Associate Director, Safety Analysis Scientist employer: Dormont Manufacturing Co
At Johnson & Johnson, we are committed to fostering a dynamic work environment that prioritises innovation and collaboration, particularly in our High Wycombe location. As an Associate Director, Safety Analysis Scientist, you will not only contribute to groundbreaking healthcare solutions but also benefit from a culture that encourages professional growth, offers hybrid working arrangements, and provides access to cutting-edge resources. Join us to be part of a team that values your expertise and is dedicated to making a meaningful impact on global health.
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We think this is how you could land Associate Director, Safety Analysis Scientist
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We think you need these skills to ace Associate Director, Safety Analysis Scientist
Some tips for your application 🫡
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How to prepare for a job interview at Dormont Manufacturing Co
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Dormont Manufacturing Co that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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