Senior Medical Writer, Regulatory Affairs - CER Medical Writing

Arthrex, Inc. is a global medical device company and a leader in orthopedic new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Regulatory Affairs department is actively searching for a Senior Writer for our Medical Writing function. The successful candidate will work alongside a department of expert regulatory and orthopedic healthcare professionals, world class medical education, and product development.

This position is on-site and based out of the Arthrex Corporate Headquarters in Naples, Florida.  Join our talented Regulatory Affairs team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.  Competitive compensation and a generous relocation package offered! 

Objective:

The Regulatory Affairs Senior Medical Writer will support MDR device registration efforts in the European Union (EU) by writing Clinical Evaluation Plans, Clinical Evaluation Reports, Post-market Clinical Follow-up Plans, Post-market Clinical Follow-up Reports, and Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents. 

Essential Duties and Responsibilities:

• Research and 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.
• Conduct technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, and Summary of Safety and Clinical Performance (SSCP) in accordance with regulatory requirements.
• Review/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.
• Maintain periodic updates, perform gap analysis, and revise existing documents as necessary.
• Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation.
• Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable.
• Work in a cross-functional team to review clinical protocols to ensure collection of data is sufficient for regulatory submissions.
• 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.

Education and Experience:

• Bachelor’s Degree required; scientific or clinical discipline preferred.
• A Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) 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.

• 5 years of experience in scientific/medical writing for medical devices is required
• Experience writing clinical evaluation documentation, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports is required
• Experience conducting literature searches and literature reviews is required.

Knowledge, Skills and Abilities:

• 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 EU regulatory framework and regulatory requirements and guidance associated with clinical regulatory document preparation, submissions, and reporting. (e.g. EU Medical Devices Regulation, MEDDEV 2.7.1, Rev. 4 - Clinical Evaluations, and MEDDEV 2.12-2, PMCF)
• Novice knowledge of human physiology/anatomy and associated medical terminology.
• Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
• Novice knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
• Advanced written, verbal and listening skills (internal/external and up/across/down) as well as strong attention to detail related to consistency, grammar, syntax, and accuracy.
• 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.
• Demonstrated ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrixed teams, including effectively leading discussions and presenting to internal business and regulatory stakeholders
• Ability to identify roles/individuals to involve for decision making within clinical evaluation assessment and report development.
• Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision.
• Ability to identify and mitigate risks and utilize judgment to make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to 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 and adapt to change as needed.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally.
• Proficient with Endnote (or equivalent), MS Office (Word, Excel, Access, PowerPoint), scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems.

Arthrex 2023 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 or protected veteran status.