Staff Medical Writer (Remote)
Staff Medical Writer (Remote)
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$ 87600 - 186700
1 Vacancy
Job Description
Staff Medical Writer (Remote)
We are currently seeking aStaff Medical Writerto join ourSports Medicine Business Unit part of theStryker Endoscopy Division. In this role you will collaborate closely with cross-functional teams including Regulatory Clinical Quality and Marketing to ensure the successful preparation of high-quality submission-ready clinical documents. These include Clinical Evaluation Reports Post-Market Clinical Follow-up documents Summaries of Safety and Clinical Performance and Clinical Study documentation.
Work Flexibility: Remote - can be based remotely anywhere within the United States.
What you will do
- Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally maintain periodic updates perform gap analysis and revise existing CERs.
- Complies 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.
- Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents.
- Addresses notified body feedback on EU clinical documents and leads them to resolution for continued EU market access of the products.
- Collaborates cross-functionally to provide input for design teams for Clinical EU MDR documentation.
- Assists with Clinical Evaluation Strategy for EU Market access.
- For all documents coordinates and manages the review process and leads discussions on document revision.
- Challenges conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.
What you need
Basic Qualifications
- Bachelors degree (BA or BS) in a technical and/or scientific discipline required.
- 4 years of Industry experience in medical technology or pharmaceuticals along with 2 years of experience in Scientific or Medical Writing relevant academic or clinical research experience (PhD Post-doc)
Preferred Qualifications
- Masters or Ph.D. or other higher degree in health-related field (RN BSN BPharm/MD/MPH) is highly preferred
- Understanding and experience in the use of scientific journals publication guidelines databases search strategies literature management software
- Knowledge and experience with MEDDEV 2.7/1 Rev. 4 EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.
- Scientific and medical writing skills.
- Knowledge of clinical operations risk management regulatory submissions and US and international guidelines.
- Ability to apply ISO FDA and related guidelines toward writing strategy and documentation.
$87600.00 - $186700.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Required Experience:
Staff IC
Employment Type
Full-Time
