Work Flexibility: Hybrid
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.
What you will do
As a Medical Writer, you will work closely with cross-functional teams (Regulatory, Quality, Marketing, Research & Development) to ensure successful preparation of high-quality submission-ready clinical documents such as clinical evaluation reports andpost market clinical follow-up documents.
Develop and completeclinical evaluation documents and post-market clinical follow-up documents for new medical devices to support global product registrations. Identify, appraise, and analyze clinical evidence from multiple sources such as current and past clinical trials, investigator-initiated studies, post market clinical follow up data, literature reviews, and meta-analyses. Maintain periodic updates.
Collaborate cross-functionally to provide input for design teamsclinical EU MDR requirements.
Conduct literature searches. Interpret and synthesize the information in clinical regulatory documents.
Develop and complete clinical documentation needed as part of product submissions, periodic updates, and reports.
Coordinate and managethe review process for all authored documents, and lead discussions on document revision.
Challenge conclusions when necessary. Independently resolve document content issues and questions from external and internal reviewers. Ensure timely approvals from all reviewers.
Serve as a subject matter expert within the department.
Recognize potential scheduling and resource conflicts for projects and provide recommendations to resolve.
Assist in the maintenance of the Stryker Instrumentslibrary for all relevant literature.
Assist in process improvements, where applicable.
What youneed
Bachelor’s Degree required,preferably in a scientific discipline
Master’s Degree in a scientific discipline required
A minimum of 4 years’ total experience inmedical writingrequired, at least 2 of these years writing EU MDR clinical documents required
A detailed understanding of MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations preferred
Must be able to think analytically, interpret data from scientific literature and clinical studies, and synthesize the results and in a clear, concise, and scientifically accurate manner.
Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (physicians, CROs, etc.) across multiple businesses.
Knowledge in clinical operations, risk management, regulatory submissions, and global guidelines preferred.
Ability to apply ISO, FDA, EU, and related guidelines toward writing strategy and documentation.
Excellent scientific and medical writing skills
Excellent interpersonal, written, and oral communication skills
Experience with DistillerSR software.