Manager, Medical Writing at Johnson & Johnson
Manager Medical Writing – Global Surgery and CSS
- United States
The Manager, Medical Writing provides leadership, motivation and strategic direction for the general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSUR) for assigned therapeutic area within J&J Global R&D Medical Device sector. You will assist in the development of credible deliverable through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices. You will also work closely with other Medical Affairs and Operations Team members including Medical Directors, Technical Specialists and Project Managers as applicable. You will also be responsible for the following:
- Managing and participating in the core process steps including search, screen, data extraction, analysis, and synthesis of data
- Utilizing software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS) and provides scientific and operational direction to the end users of these tools for assigned projects
- Developing and monitoring metrics for systematic literature reviews within assigned therapeutic area providing visibility of issues and enable corrective and preventive action to be taken as necessary
- Participating in discussions and actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process to provide scientific and medical strategic planning and execution for assigned medical writing activities and systematic literature reviews
- Demonstrating an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study design, ensures compliance with medical device regulations globally, and escalates any new or emerging risks
- Providing input on clinical data from the medical and scientific literature to ensure results are presented in clear, concise, and scientifically accurate manner requiring the ability understand and interpret statistical results of clinical studies.
- Gather information (timelines, projects, documents) to forecast and budget resources needs for deliverables
- A minimum of a Bachelor’s degree with 8 years’ relevant experience OR a Master’s with 5 years relevant experience OR a PhD with 3 years relevant experience is required.
- Experience in related industry is also required.
- Knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
- Skilled in narrative or systematic literature reviews (PRISMA, Cochrane) with demonstration in qualitative and quantitative synthesis in conjunction with scientific and medical writing is preferred
- Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred
- Ability to understand and interpret statistical results of clinical studies and understanding good data management practices is required.
- Experience in medical writing or demonstration in scientific writing ability
- Experience using software systems to manage literature data (i.e Distiller) is preferred
- Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence is required.
- Strong oral communication, presentation, project management and prioritization skills and excellent interpersonal relationships is also required.
- Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager) is also required.
This position is REMOTE.
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
- United States
- Medical Device Business Services, Inc (6029)
- Job Function
- Requisition ID
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