Job Details

PR: 53-57.50

HM’s Top Needs:

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

Years’ Experience Required: see below

Will the contractor be working 40 hours a week? If not, weekly estimate?

Work Location: Remote

                Do they need to be local to any MDT office and if so where? No

Does this person need to be on site? If so, full time or part time? No

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.