Senior Medical Writer

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🕒 March 3

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Artex Risk Solutions

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1997

💸 Finance

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.

📋 Description

• Perform systematic literature searches and reviews for clinical regulatory document creation. • Interpret and synthesize literature information for use in clinical regulatory documents. • Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling change. • Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with regulatory requirements. • Maintain periodic updates, perform gap analysis, and revise existing documents as necessary. • Work in a cross-functional team to establish clinical study protocols and reports, data summaries from raw data and document strategies. • Review clinical protocols to ensure collection of data is sufficient for regulatory submissions. • Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation. • Communicate, as the primary liaison, with the Project Manager and other cross-functional teams, as applicable, to provide input and gather required information for assigned projects. • Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable. • 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 to ensure all data and information is truthful, accurate, and verifiable against source documentation to confirm compliance and traceability. • Recommend changes to company procedures in response to changes in regulations, published guidance, and/or standards. • Assist in writing or updating standard operating procedures, work instructions, or policies. • Participate in internal or external audits, as required. • May develop or conduct employee training.

🎯 Requirements

• Bachelor’s degree in Life Science, Biological Science, or related discipline required. • 5 years relevant experience required in clinical medical writing within the life science industry. • EU MDR/MDD experience required.

🏖️ 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)