Clinical Evaluation Medical Writer- Remote

Job Description

Job Description

Title: Clin Evaluation Medical Writer
Location: Minnesota- 100% Remote
Duration: 12 Months+ Possible Extension
Shift: 1st Shift

1. Strong Clinical Evaluation experience, writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Follow Up Plan (PMCF P), Post Market Follow up Report (PMCF R), Summary of Safety Clinical Performance (SSCP), Periodic Safety Update Report (PSUR)

2. Strong project management skills

3. Strong proactive communication skills

Education Required:
Baccalaureate degree and minimum of 4 years relevant experience OR advanced degree with minimum of 2 years relevant experience

Job Description:

• 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.

Job 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 (PMCF-P), Post-Market Clinical Follow-up Reports (PMCF – 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.

Job Requirements:

• 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 the following and other duties may be assigned.

• 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.

• 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.

• 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.

• 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.

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

• 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 and 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.