Summary
Leading expert individual contributor who is viewed as a valuable resource by peers in a scientific/technology field. Consults on critical methods and research to achieve operational, functional, and/or business targets with measurable impact on department results. Masters knowledge and skills of engineering methods, and serves as a valuable resource to peers. Manages major complex projects of strategic importance, involving cross-functional teams.
Description
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. Learn more at https://www.jnj.com
Job Function:
Product SafetyJob Sub Function:
Product Safety Risk ManagementJob Category:
Scientific/TechnologyAll Job Posting Locations:
GB006 High WycombeJob Description:
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. Learn more at https://www.jnj.com/innovative-medicine
About 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 to 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. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for an Associate Director (AD) Safety Analysis Scientist (SAS) - Oncology to be located within commutable distance of High Wycombe, United Kingdom (hybrid). Remote work options may be considered on a case-by-case basis and if approved by the Company. The AD SAS provides scientific expertise and leads the safety assessment of assigned products and, 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.
In summary, the AD SAS will support product Safety Management Teams (SMTs) and collaborate closely with cross-functional safety partners to determine a product’s safety strategy, conduct safety analyses, and lead safety data review meetings while interpreting safety information to make informed recommendations. This role involves assisting the Medical Safety Office (MSO) with SMT-related activities and contributing to key safety and clinical documents, leveraging in-depth product knowledge as the main point of contact. The AD SAS will provide training and oversight for team deliverables, particularly complex reports, while functioning independently with minimal guidance from the Director and Therapeutic Area Lead (TAL). Strong relationship-building skills are fundamental in influencing safety partners effectively and shaping decisions that drive positive outcomes.
Are you ready to make a significant impact on safety management and innovation - then read further!
You will be responsible for:
- Take charge of strategy discussions, collaborating with the Therapeutic Area Safety Head (TASH), Medical Safety Office (MSO), and other key stakeholders. Handle data retrieval, analysis, report writing, and revisions to ensure comprehensive evaluations and guarantee high-quality reports with minimal comments and revisions from stakeholders.
- Provide valuable insights and reviews for key regulatory and clinical documents, supporting interactions with health authorities on safety and risk management through clear written and verbal communication.
- Show your leadership skills within the Safety Management Team (SMT) while supporting the MSO. Lead cross-functional training initiatives to improve stakeholder knowledge and skills.
- Lead proactive reviews of safety data to formulate a safety position utilisable for aggregate safety reports. Take on novel projects to build value and drive innovation, exploring creative ways to present data and prepare reports while improving efficiencies within your programmes.
- Act as a Subject Matter Expert (SME) during audits and inspections, while handling unscheduled reports within the Aggregate Report Calendar and overseeing deliverables prepared by team members, particularly complex reports.
- Participate in or spearhead departmental and cross-functional initiatives that promote teamwork and efficiency, encouraging management of activities within smaller Therapeutic Areas as applicable, along with overseeing contractor positions within your team when needed.
- Serve as backup to the TAL during their absence.
Qualifications / Requirements:
- A Degree in a Healthcare-related or Biomedical Science area with 11+ years industry experience is required, OR an advanced relevant degree (or higher) with 8+ years proven industry experience.
- Medical writing or PV experience.
- 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 analyse complex medical-scientific data from a broad range of disciplines is required.
- Ability to interpret and present complex data to determine benefit-risk impact is required.
- Ability to independently influence, negotiate and connect with both internal and external customers.
- To effectively interact with collaborators, team members and business partners. Excellent English verbal and written communication.
- Ability to work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
Preferred:
- Clinical experience
- Early development submission experience
Benefits
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits We are J&J Innovative Medicine!
All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.
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