Sr. Medical Writer, Regulatory Affairs (REMOTE OR ONSITE)

Main Objective:

Responsible for managing specific aspects of the Arthrex Regulatory Affairs Medical Writing program with an emphasis on supporting regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts for international markets.  This role will specialize in writing, editing, and reviewing clinical regulatory documents as well as support and execute general medical writing activities. These activities include performing systematic literature reviews, as well as writing 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) reports,  Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales. The Medical Writer will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure successful preparation of high-quality submission-ready clinical documents that lead to and maintain regulatory approval/clearance/licensure for Arthrex’s medical devices. 

Essential Duties and Responsibilities:

1. Perform systematic literature searches and reviews for clinical regulatory document creation. Interpret and synthesize literature information for use in clinical regulatory documents.
2. 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.
3. 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.
4. 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.
5. 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.
6. Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable.
7. Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
8. 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.
9. Recommend changes to company procedures in response to changes in regulations, published guidance, and/or standards.
10. Assist in writing or updating standard operating procedures, work instructions, or policies.
11. Participate in internal or external audits, as required.
12. May develop or conduct employee training.