Medical Writer

Kelly FSP is proud to collaborate with a prestigious client in the medical device sector, and we are currently seeking a passionate Medical Writer who will be Authoring or supporting regulatory documents including Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Systematic Literature Reviews for both State of the Art and individual Subject Devices, as well as associated documentation as needed

Primary Responsibilities

• Author/support regulatory documents including Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Systematic Literature Reviews for both State of the Art and individual Subject Devices, as well as associated documentation as needed (such as Plans and Search Protocols).
• Comprehensively and accurately synthesize and analyze the clinical and non-clinical data from medical and scientific publications as well as technical documents reporting on a range of medical devices.
• Ensure documents are compliant with local procedures, regulatory requirements, and client guidelines.
• Demonstrate an understanding in assigned therapeutic areas.
• Possess knowledge of device technology, features, and specifications.
• Familiar with industry standards, clinical practice guidelines, safety reporting, and relevant MDR regulations/specifications.
• Understand the components of the state-of-the-art and how it integrates within the content of the CER.
• Determine data applicability in different sections of the document, including the concepts and data required for equivalence.
  
• Ensure that deliverables are linked to appropriate quality systems and regulatory documents such as Risk Management, Post-Market Surveillance (PMS), etc., to make information consistent and accessible where needed.
• Actively communicate with cross-functional business partners such as Medical Directors, Post-Market Surveillance, Design Quality Engineers, Product Development, Clinical Affairs, and Regulatory Affairs relating to identify the necessary clinical and technical information for assigned projects.
• Ensure template, internal and external guidelines are followed as appropriate.
• Perform gap analysis of the source documents provided, identify gaps, and inform about missing documents proactively.
• Understanding of basic statistics.
• Possess the ability to multi-task, using multiple software tools.
• Responsible for end-to-end ownership of the document.

Secondary Responsibilities

• Ability to work in a team atmosphere.
• Alert and escalate to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.

Minimum Qualifications

• BA, BS, or BSN is required; advanced degree is preferred. Minimum of 3 to 5 years of relevant experience in identified functional domain/business workstream.
• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation is preferred.
• Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred.
• Able to understand and interpret statistical results of clinical studies and understands good data management practices is preferred.
• Experience in medical writing or demonstration in scientific writing ability is required.
• Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence is required.
• Strong oral communication, presentation, project management and prioritization skills are required.
• Excellent interpersonal relationships are required.
• High proficiency in Microsoft Office Suite and reference management software are required.

You will join a team of dedicated professionals in a collaborative and innovative environment. Your expertise can make a difference in the lives of many. Join us in shaping the future of medical device development.