Senior Medical Writer, Redaction
Syneos Health
Staff Medical Writer
Stryker
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $87,600 - $186,700 per year
Job Level
Lead
About the role
- work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing)
- ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, Summary of Safety and Clinical Performance and Clinical Study documents
- Compile clinical evidence from multiple sources such as current and past clinical trials, post-market clinical follow up data and literature review updates, ad-hoc analysis, meta-analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates
- Responsible for the development and completion of Clinical Evaluation Reports (CERs) for new medical devices to support product registrations internationally
- maintain periodic updates, perform gap analysis, and revise existing CERs
- Collaborate cross-functionally to provide input for design teams for Clinical EU MDR documentation
- Work in a cross-functional team to support clinical study protocols and reports, data summaries from raw data and document strategies
- Prepare literature searches for drafting document content
- Interprets literature information and synthesizes the information in clinical regulatory documents
- coordinate and manage the review process, and lead discussions on document revision
- Challenge conclusions when necessary
- Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers
- Assist in the development of internal procedures, templates and style guides
- Serve as a subject matter expert within department
- Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve
- Assist in the maintenance of the Stryker Endoscopy library for all relevant literature
- Assist in the process improvements for the medical writing team.
Requirements
- Required Bachelor’s Degree, preferably in a Scientific Discipline
- 4+ years of combined experience in healthcare or medical devices
- 2+ years of previous medical writing experience in a healthcare product or medical device industry
- Strong scientific and medical writing skills
- Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document
- Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
- Preferred Master of Science Degree or Ph.D./ Pharm. D./M.D.
- Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations
- Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines
- Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation.
Benefits
- salary plus bonus eligible + benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical writingclinical evaluation reportsdata synthesisliterature reviewgap analysisdocument revisionanalytical thinkingmedical writingregulatory submissionsISO guidelines
Soft skills
cross-functional collaborationcommunicationproblem-solvingproject managementinterpersonal skillssubject matter expertisecritical thinkingtime managementleadershipadaptability
Certifications
Bachelor’s DegreeMaster of Science DegreePh.D.Pharm. D.M.D.
