Clinical Report Writer II

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

Paragon 28, a Zimmer Biomet Company focused on orthopedic medical devices for the foot and ankle, is hiring a Clinical Report Writer II. The Clinical Report Writer II is responsible for the review and research of medical and scientific literature in order to create, edit, and coordinate production of clinical documents, with a focus on Clinical Evaluation Reports (CERs). In addition, the Clinical Report Writer II will review, contribute toward, or author other clinical or technical documents that support clinical, regulatory, and corporate needs of the company.

How You'll Create Impact

Essential Responsibilities and Duties

• 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 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 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, 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.

Your Background

Qualifications

• Minimum of bachelor's degree or equivalent in engineering, scientific or medical discipline.
• Minimum of 3 years of medical writing experience including CEPs, CERs, all Post-Market Plans / Reports and SSCPs.
• Experience and skill performing medical literature searches (PubMed, Google Scholar, etc.)
• Experience with CER writing per EU MDR 2017/745 and / or MEDDEV.
• Excellent written communications skills - strong attention to detail related to consistency, grammar, syntax, and accuracy.
• Scientific/research background (i.e. understands research design, methodology, and statistics) preferred
• Engineering or regulatory experience in the medical device industry preferred.
• Basic project/timeline management skills and organizational/prioritization skills preferred.
• Experience in orthopedics/podiatry/spine preferred
• Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
• Self-starter attitude - ability to learn quickly and self-educate on different medical device products and procedures. Experience with progressing multiple projects concurrently.
• Expertise in Microsoft Office Suite. Experience in Smartsheet.

Travel Expectations

Compensation Data

Salary Range: $82,000 - $116,000 USD annually

EOE