Senior Medical Writer (Remote)

About the role

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 Senior Medical Writer 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 position will play a critical role in regulatory approval efforts for international markets.

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.
• Aid 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.

Requirements

• Bachelor’s degree in Life Science, Biological Science, or related discipline required.
• 5 years relevant experience required in clinical medical writing within the life science industry.
• EU MDR/MDD experience required.

Qualifications

• 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 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.

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).
• Excellent written and oral communication skills required.

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)