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:
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.
Additional Duties and Responsibilities
May coach and review the work of lower level professionals.
Education
Bachelor’s degree in Life Science, Biological Science, or related discipline required. Advanced degree preferred.
American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices
Regulatory Affairs Certification (RAC) preferred.
Experience
5 years relevant experience required in clinical medical writing within the life science industry.
EU MDR/MDD experience required.
Experience in high quality medical/technical writing required.
Clinical or statistical experience required.
Experience authoring Clinical Evaluation Reports.
Orthopedic medical device experience preferred.
Knowledge
Complete understanding and wide application of technical principles, theories and concepts in the field. General knowledge of other related disciplines.
Excellent understanding of scientific or clinical research and methods.
Advanced knowledge of US and international regulatory framework and regulatory requirements and guidance associated with clinical regulatory document preparation, submissions, and reporting.
Novice knowledge of human physiology/anatomy and associated medical terminology.
Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
Intermediate knowledge of current medical device regulations, standards, guidances and regulatory requirements for medical devices in region of specialization.
Intermediate knowledge of 21 CFR 820/ISO 13485, ISO 14971, ISO 14155, MDD, MDR, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
Intermediate knowledge of product life cycle, product development process, design control and change control.
Novice knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
Proficient with Endnote (or equivalent), MS Office (Word, Excel, Access, PowerPoint), scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems.
Discretion/Latitude
Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgement, overall adequacy, and accuracy.
Impact
Contributes to completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in allocation of additional resources.
Liaison
Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts on routine matters.
Problem Solving
Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organization objectives.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
