J&J Family of Companies Senior Medical Writer in Warsaw, Indiana
The Senior Medical Writer provides input and reviews the strategic direction of the assigned medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), PMA FDA Reports, and State of the Art (SOA) Reviews for assigned therapeutic areas within Johnson & Johnson Global Medical Device (HMD) businesses within his/her scope of responsibility.
POSITION DUTIES & RESPONSIBILITIES:
Participates in the planning and execution of general medical writing activities and/or systematic literature reviews for assigned therapeutic area.
Participates 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 processes to provide scientific and medical strategic planning and execution for assigned medical writing activities.
Demonstrates a thorough 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.
Critically reviews and edits protocols and reports prepared by Medical Writers according to company procedures to help produce high-quality deliverables in accordance with the team project plan.
Provides strategies that feed into core process steps for the planning of reports including literature search, article screening, publication data extraction, and synthesis of the safety and performance outcomes.
Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
Provides consultation for the Medical Writer on project-specific questions.
Advises on project-specific software tool designs (e.g data management systems) to house clinical study data from literature.
Reviews and edits scientific writing in a form of feedback to the assigned Medical Writer.
Confirms the applicable protocol and report templates are used and in alignment with other planning documents and inputs (e.g. product labeling, risk management plans)
Presents the results of reviews at internal meetings for strategic planning purposes (as applicable).
Supports responses to queries from regulatory bodies (e.g. Notified Bodies).
BA, BS, or BSN with 5 years of related experience or a Master’s with 3 years relevant experience or a PhD with 2 years relevant experience is required
Rrelated industry is required
Knowledge of medical device regulatory requirements or Clinical Evaluation Report (CER) document creation is preferred
Clinical research, q uality regulatory compliance, and a dverse event reporting is preferred
S killed in narrative or systematic literature reviews (PRISMA, Cochrane) with demonstration in qualitative and quantitative synthesis in conjunction with scientific and medical writing is preferred
Do you have the ability to understand and interpret statistical results of clinical studies and understanding good data management practices is required
Experience or evidence of (e.g. publications) in scientific/medical writing ability is required
Experience using software systems to manage literature data is preferred
Ability to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence is required
Proficiency in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager) is required
Strong oral communication, presentation, project management and prioritization skills and excellent interpersonal relationships is required
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 based on disability.
Medical Device Business Services, Inc (6029)
J&J Family of Companies
- J&J Family of Companies Jobs