Principal Medical Writer

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 Principal Specialist, Medical Writing who is 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 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. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position is eligible for remote work.

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.

Knowledge and Skills:

• 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 medical terminology.
• Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
• Advanced knowledge of current medical device regulations, standards, guidances and regulatory requirements for medical devices in region of specialization.
• Advanced knowledge of 21 CFR 820/ISO 13485, ISO 14971, ISO 14155, MDD, MDR, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
• Advanced knowledge of product life-cycle, product development process, design control and change control.
• Intermediate knowledge of clinical trial strategy and study design, and sponsor reporting requirements.

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 other is preferred, with a specialty in Editing/Writing or Medical Devices Regulatory Affairs Certification (RAC) preferred.
• 10+ 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.

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn, understanding the implications of new information for both current and future problem-solving and decision-making.

Abilities Requirements:

Ability to comprehend principles of engineering, physiology and medical device use. Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret clinical and regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast paced environment.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Excellent written and oral communication skills required.

Arthrex 2024 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 or protected veteran status.