Medical Job as Clinical Report Writer at Zimmer Biomet in the US
If you are seeking a rewarding medical job in the United States, this opportunity with Zimmer Biomet could be the perfect next step. As a global leader in medical technology, Zimmer Biomet continues to shape innovation in orthopedics. This Clinical Report Writer II position offers professionals a chance to grow within leading Zimmer Biomet jobs while contributing to regulatory and clinical excellence in the medical device industry.
Job Details:
- Job Title: Clinical Report Writer II
- Location: Englewood, Colorado, United States
- Job Category: Quality & Regulatory
- Job ID: 9086
- Employment Type: Full-Time
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Salary Range: $82,000 – $116,000 USD annually
About the Company
Zimmer Biomet is a global medical technology leader for nearly 100 years, enhancing a patient’s mobility every 8 seconds through its products or technologies. Professionals exploring Zimmer Biomet careers join a company committed to innovation, patient mobility, and renewed life worldwide. Zimmer Biomet fosters an environment where every team member feels inspired, valued, and empowered – making it one of the most sought-after medical jobs in the United States.
Job Description
Paragon 28, a Zimmer Biomet Company focused on orthopedic medical devices for the foot and ankle, is hiring a Clinical Report Writer II. This medical job is responsible for the review and research of medical and scientific literature to create, edit, and coordinate the production of clinical documents, with a focus on Clinical Evaluation Reports (CERs).
The Clinical Report Writer II will also review, contribute toward, or author other clinical or technical documents supporting clinical, regulatory, and corporate needs. This opportunity stands out among Zimmer Biomet jobs for professionals with regulatory and medical writing expertise.
Qualifications
- Bachelor’s degree or equivalent in a medical discipline.
- Minimum 3 years of medical writing experience, including CEPs, CERs, Post-Market Plans/Reports, and SSCPs.
- Experience performing medical literature searches (PubMed, Google Scholar, etc.).
- Experience with CER writing per EU MDR 2017/745 and/or MEDDEV.
- Excellent written communication skills with strong attention to grammar, syntax, and accuracy.
- Scientific/research background preferred.
- Engineering or regulatory experience in the medical device industry preferred.
- Project management and organizational skills preferred.
- Experience in orthopedics/podiatry/spine preferred.
- Proficiency in Microsoft Office Suite and Smartsheet.
Key Responsibilities
- Authors Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs), including the clinical sections of any/all regulatory authority requests.
- Authors Post-Market Surveillance Plans, Post-Market Clinical Follow-Up Plans, Post-Market Surveillance Reports, Post-Market Clinical Follow-Up Reports, Periodic Safety Update Reports, and Summary of Safety and Clinical Performance reports.
- Collaborates with internal or external statisticians to establish appropriate post-market clinical follow-up sample sizes and data thresholds to meet safety and performance objectives.
- Determines safety and performance objectives for products and ensures that supporting data is sufficient per country requirements.
- Reviews Clinical Evaluation Assessment Reports (CEARs) from the notified body and provides approval or appropriate editing.
- Maintains/updates existing company CERs according to internal SOPs.
- Responsible for timing and communication of updates to meet quality system country-specific requirements.
- Contributes to internal team review for CERs and other documents.
- Contributes toward post-market clinical safety assessment and risk reviews.
- Collaborates with international regulatory, commercial, and global entry teams on appropriate prioritization of projects based on timelines and availability of data.
- Serve as the clinical representative on relevant project team meetings, when appropriate.
- Conduct literature searches on products/product families.
- Provide product guidance and expertise to help team members with this task as needed.
- Reviews Clinical Study Reports.
- Summarizes data held by the manufacturer and internal test reports to feed input into CERs.
- Critically appraise scientific literature and summarize relevant articles, products, and surgical procedures.
- Supports business development or investor relations activities, as required.
- Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
- Manages timelines and communication to ensure deliverables and milestones are met.
- Prepares for and participates in audits and conformity assessments as needed.
- Participates in the delivery of responses as needed for regulatory authorities.
- Interacts with internal and international teams (engineering/marketing/regulatory) to define the strategy for development of Clinical evidence to support global entry of new products into relevant markets.
- Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes, and the ability to keep abreast of current literature.
- Conducts proofreading, editing, and document formatting of various documents as needed.
- Systematically integrates feedback from audits/conformity assessments and leads document completion/approval activities.
- Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
- Communicates/collaborates with outside consultants in the development of clinical strategy/ CERs when necessary.
