Clin Evaluation Medical Writer

Job Description

Job Summary:

• The Senior Clinical Evaluation Medical Writer is responsible for authoring, reviewing, and managing clinical evaluation documents and reports in compliance with regulatory requirements and industry standards.
• This role involves synthesizing clinical data, scientific literature, and regulatory guidelines to create clear, concise, and evidence-based documentation that supports the safety and performance of medical devices.
• The writer collaborates closely with cross-functional teams to ensure the timely delivery of high-quality clinical evaluation reports (CERs) and related documents.
• Strong analytical skills, attention to detail, and the ability to communicate complex medical and scientific information effectively are essential for success in this role.

Duties & Responsibilities:

• Review and summarize scientific literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
• Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
  Maintains database of peer-reviewed literature.
• Develop state of the art (SOTA) on product family for its intended purpose.
• Create & maintain plans and reports for regulatory authorities, including but not limited to Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up Plans.
• (Product-P), Post-Market Clinical Follow-up Reports (Product – R), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR).
• Reports instances of complaints/adverse events from literature.
• Create responses for audit/submission queries.

Required Skills:

• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
• Experience writing clinical evaluation documents.
• Medical Device experience.
• Strong project management skills.
• Strong communication skills.
• Ability to deliver and manage projects assigned and work with other stakeholders to achieve desired results.
• Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities May Include :

• Review and summarize scientific literature.
• Reports instances of complaints/adverse events from literature to GCH.
• Create responses for audit/submission queries.
• Maintains database of peer-reviewed literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
• Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
• Develop state of the art on product family for its intended purpose.
• Create & maintain plans and reports for regulatory authorities.
• Review/approve other documentation for device development.
• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

Specialist Career Stream:

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects – from design to implementation – while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Differentiating factor Autonomy:

• Seasoned individual contributor.
• Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:

• May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:

• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Makes improvements of processes, systems or products to enhance performance of the job area.
• Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:

• Communicates with senior internal and external customers and vendors.
• Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management:

• May provide guidance, coaching and training to other employees within job area.
• May manage projects, requiring delegation of work and review of others’ work product.

Required Knowledge & Experience:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.