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Sr. Medical Writer (12 month contract // REMOTE, team based in CO):

Team is open to fully remote candidates but would give slight preference to a candidate that is available to come on site part time in MN or CO

HM's Top Needs:

• Deep knowledge of EU MDR and Medical Writing from CER, CEP, PMCF Plan & Report
• 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.

Years’ Experience Required:

• Requires a Bachelor’s Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 3+ years relevant experience.
• Strong preference for someone with 5+ years of experience.

Duties:

• Review and summarize scientific literature.
• Reports instances of complaints/adverse events from literature to GCH.
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Writing/Editing, Strategy/Planning, and Analyst

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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