Medical Writer II - 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 Medical Writer II 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 Medical Writer II 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

• 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

• 2 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

• Frequent use and application of technical standards, principles, theories, concepts and techniques.
• Excellent understanding of scientific or clinical research and methods.
• Intermediate 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.
• Novice knowledge of orthopedic terminology, surgery principles, theories, and products.
• Novice knowledge of current medical device regulations, standards, guidances and regulatory requirements for medical devices in region of specialization.
• Novice knowledge of 21 CFR 820/ISO 13485, ISO 14971, ISO 14155, MDD, MDR, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
• Novice 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 solutions to a variety of technical problems of moderate scope and complexity.