Senior Medical Writer

Job not on LinkedIn

August 20

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

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Artex Risk Solutions

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Finance • Insurance • Risk Management

Artex Risk Solutions is a leader in alternative risk management, providing innovative solutions for both large and small organizations. They specialize in creative risk management strategies that help clients optimize their cost of risk, leveraging expertise in capital solutions, specialty risk transfer, and carrier outsourcing services. With a global presence and a commitment to challenging traditional approaches, Artex aims to empower businesses to make informed risk management decisions and enhance their operational efficiency.

501 - 1000 employees

Founded 1997

💸 Finance

📋 Description

• Manage regulatory medical writing for international markets; write, edit, and review CEPs, CERs, PMCF plans, SSCPs, PMS plans, PMSRs, and PSURs in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales. • Collaborate with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure submission-ready clinical documentation; liaise with Project Manager and other cross-functional teams as applicable to provide input and gather required information. • Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation; review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures. • Maintain periodic updates, perform gap analysis, and revise existing documents as necessary; participate in audits; may develop or conduct employee training.

🎯 Requirements

• Bachelor's degree in Life Science, Biological Science, or related discipline required. • Advanced degree preferred, AMWA certification or RAC preferred. • 5 years relevant experience required in clinical medical writing within the life science industry. • EU MDR/MDD experience required. • Clinical or statistical experience required. • Experience authoring Clinical Evaluation Reports.

🏖️ 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 • Free Onsite Medical Clinics • Free Onsite Lunch • 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.