Senior Medical Writer (Remote) Job at Arthrex in Town of Florida

Senior Medical Writer (Remote) – Arthrex

Requisition ID: 64744

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Medical Writer who is responsible for managing specific aspects of the Arthrex Regulatory Affairs Medical Writing program with an emphasis on supporting regulatory approval, clearance, and licensure for medical devices in the most efficient and compliant manner. This position will play a critical role in regulatory approval efforts for international markets and will specialize in writing, editing, and reviewing clinical regulatory documents as well as supporting general medical writing activities, including systematic literature reviews, Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post‑Market Clinical Follow‑Up plans, Summary of Safety and Clinical Performance reports, Post‑market Surveillance plans, and Periodic Safety Update reports in accordance with global regulatory requirements.

Essential Duties and Responsibilities

• Perform systematic literature searches and reviews for clinical regulatory document creation, interpreting and synthesizing literature information for use in these documents.
• Compile clinical evidence from multiple sources such as current and past clinical trials, post‑market clinical follow‑up data, literature review updates, ad‑hoc analysis, meta‑analyses, or other sources of safety and performance data to meet essential requirements for CE Mark application, Declaration of Conformity, and EU market clearance.
• Write, edit, and proofread Clinical Evaluation Plans, Clinical Evaluation Reports, Post‑Market Clinical Follow‑Up plans and reports, Summary of Safety and Clinical Performance reports, Post‑market Surveillance plans and reports, and Periodic Safety Update reports in accordance with regulatory requirements; maintain periodic updates and revise documents as necessary.
• Work in a cross‑functional team to establish clinical study protocols, data summaries, and document strategies; review protocols to ensure data collection is sufficient for regulatory submissions.
• Ensure successful preparation of high‑quality submission‑ready clinical documentation, acting as primary liaison with the Project Manager and other teams to gather required information.
• Evaluate the risk of proposed regulatory strategies and offer solutions based on available clinical data.
• Provide technical review of data or reports incorporated into regulatory submissions to ensure scientific rigor and clarity.
• Review or edit clinical regulatory documentation for completeness, consistency, and conformity to regulations, guidelines, and internal policies to ensure accuracy and traceability.
• Recommend procedural changes in response to regulatory changes and published guidance.
• Assist in writing or updating standard operating procedures, work instructions, or policies.
• Participate in internal or external audits as required.
• Develop or conduct employee training.

Education and Experience

• Bachelor’s degree in Life Science, Biological Science, or related discipline required.
• Advanced degree preferred.
• American Medical Writing Association (AMWA) certification or similar preferred, with a specialty in Editing/Writing or Medical Devices.
• Regulatory Affairs Certification (RAC) preferred.
• Five years of relevant experience required in clinical medical writing within the life science industry.
• Experience with EU MDR/MDD required.
• Clinical or statistical experience required.
• Experience authoring Clinical Evaluation Reports required.

Reasoning Ability

Ability to identify and define problems, collect data, analyze facts, draw valid conclusions, and communicate findings verbally and in writing to a variety of audiences. Ability to interpret technical instructions, formulate logical conclusions, and adapt to new information for decision‑making.

Abilities Requirements

Comprehend engineering, physiology, and medical device use principles; manage master documents with confidentiality; research, read, analyze, and interpret clinical literature and regulatory documents; summarize scientific data; organize complex information; make decisions based on risk/benefit assessments; plan and manage projects; work effectively in cross‑functional teams; adapt to changing priorities; build relationships; thrive in a fast‑paced environment.

Machine, Tools, and/or Equipment Skills

Proficiency with personal computers and software, particularly SAP, Microsoft Office Suite (Excel, Word, PowerPoint), and Adobe Acrobat.

Language and Communication Skills

Excellent written and oral communication skills; ability to convey ideas clearly and record data per procedures.

Mathematical Skills

Ability to apply mathematical principles as required for job performance.

Benefits

• Medical, Dental, and Vision Insurance
• Company‑Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans: Accident, Cancer, Hospital, Critical Illness
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Marketing, Public Relations, and Writing/Editing

Industry

Medical Equipment Manufacturing