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 a focus on mentorship and career development.
- Why this job: Make a real impact in the fight against cancer and improve patient outcomes.
- Qualifications: Bachelor's degree in healthcare or biomedical science with relevant experience.
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.
As guided by Our Credo, Johnson & Johnson 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 Johnson & Johnson, 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: 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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-080033. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
We are searching for the best talent for a Manager, Safety Analysis Scientist, located in High Wycombe, UK. This is a hybrid position that requires you to be on site three days a week.
Purpose: 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.
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-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.
- 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 / Requirements:
Education: Bachelor’s Degree Required: Healthcare-related or Biomedical Science (9+ years of industry experience or equivalent). Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).
Experience: Required: Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements. Medical writing or PV experience. 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.
Preferred: Clinical experience.
Required Skills:
Preferred Skills: Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing.
Manager, Safety Analysis Scientist in High Wycombe employer: 7360-Janssen-Cilag Limited Legal Entity
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a collaborative and inclusive work environment in High Wycombe, where innovation thrives. Our commitment to employee growth is evident through continuous learning opportunities and mentorship, empowering you to make a meaningful impact in healthcare. Join us to be part of a team that not only values your contributions but also champions diversity and personal development, all while working towards groundbreaking advancements in medicine.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Safety Analysis Scientist in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to people in your field, especially those at Johnson & Johnson. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by researching the company culture and values. Johnson & Johnson is all about health and innovation, so think about how your experiences align with their mission and be ready to share!
✨Tip Number 3
Practice your pitch! You want to clearly communicate your skills and how they relate to the role of Manager, Safety Analysis Scientist. Keep it concise and impactful—show them why you're the one they need!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're serious about joining the team at Johnson & Johnson.
We think you need these skills to ace Manager, Safety Analysis Scientist in High Wycombe
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Manager, Safety Analysis Scientist role. Highlight relevant experience in safety evaluations and medical writing, and don’t forget to showcase your leadership skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about innovative medicine and how your background aligns with the responsibilities of the role. Keep it concise but impactful.
Showcase Your Communication Skills:Since this role requires excellent verbal and written communication, make sure your application reflects that. Use clear language and structure your documents well to demonstrate your ability to present complex data effectively.
Apply Through Our Website:We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to the right team. Don’t miss out on this opportunity!
How to prepare for a job interview at 7360-Janssen-Cilag Limited Legal Entity
✨Know Your Stuff
Make sure you have a solid understanding of safety analysis and the specific responsibilities of the Manager, Safety Analysis Scientist role. Brush up on relevant medical concepts and safety activities in drug development. Being able to discuss these topics confidently will show that you're serious about the position.
✨Showcase Your Leadership Skills
Since this role involves mentoring and leading safety evaluations, be prepared to share examples of your leadership experience. Think of times when you've influenced decisions or guided a team through complex projects. This will demonstrate your ability to thrive in a matrix environment.
✨Prepare for Data Discussions
You’ll likely need to interpret and present complex data during the interview. Practice explaining safety data and benefit-risk assessments clearly and concisely. Use real-world examples to illustrate your analytical skills and how you’ve approached similar challenges in the past.
✨Engage with Questions
Interviews are a two-way street! Prepare thoughtful questions about the company’s approach to safety management and their innovative medicine initiatives. This not only shows your interest but also helps you gauge if the company aligns with your values and career goals.
