Senior Medical Writer

Redbock - an NES Fircroft company; United States; Remote; USD 56,000 - 83,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Sr. Medical Writer for a 12-month remote contract. The ideal candidate will possess deep knowledge of EU MDR and substantial experience in medical writing. Responsibilities include reviewing scientific literature and developing regulatory documentation. This role offers a competitive salary and the flexibility of remote work.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• Requires minimum of 4 years of relevant experience.
• Strong preference for candidates with 5+ years of experience.
• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

Responsibilities

• Review and summarize scientific literature.
• Conduct comprehensive literature searches.
• Develop and maintain plans for regulatory authorities.

Skills

Deep knowledge of EU MDR

Medical Writing

Process Improvement

Literature Review

Critical Analysis

Education

Bachelor’s Degree

Advanced degree preferred

Job description

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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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