Senior Medical Writer (Remote)

Requisition ID: 65196 Title:Senior Medical Writer (Remote) 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.

Education and Expereince:

• 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.

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 delive Apply tot his job Apply To this Job