Zimmer Biomet · 18 hours ago
Clinical Report Writer II
Englewood, CO
Full-time
Onsite
Mid Level
$82K/yr - $116K/yr
3+ years expZimmer Biomet is a global medical technology leader focused on enhancing patient mobility. The Clinical Report Writer II is responsible for creating and editing clinical documents, particularly Clinical Evaluation Reports, while collaborating with various teams to ensure compliance with regulatory standards.
Health CareManufacturingMedical DeviceProduct Design
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 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
Qualification
Required
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
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
Preferred
Scientific/research background (i.e. understands research design, methodology, and statistics)
Engineering or regulatory experience in the medical device industry
Basic project/timeline management skills and organizational/prioritization skills
Experience in orthopedics/podiatry/spine
Benefits
Development opportunities
Robust employee resource groups (ERGs)
A flexible working environment
Location specific competitive total rewards
Wellness incentives
A culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Ivan Tornos
Chairman, President and CEO
D
David DeMartino
Senior Vice President, Investor Relations
Recent News
Inside INdiana Business
2026-01-24
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