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Randstad Medical Writer - REMOTE in Waltham, Massachusetts

Medical Writer - REMOTE

job details:

  • location:Waltham, MA

  • salary:$48 - $60 per hour

  • date posted:Wednesday, January 13, 2021

  • job type:Contract

  • industry:Health Care and Social Assistance

  • reference:815528

job description

Medical Writer - REMOTE

job summary:

Randstad is looking to hire a Medical Writer for a 100% remote 6 month contract (w/ a potential to extend or convert permanent) for a client in the Healthcare industry. If you are looking for a content development and management position in which you will be reviewing and researching medical and scientific literature, see the details below.

Ideal candidate MUST have 2+ years experience in medical writing, clinical evaulation, and/or medical discipline. MEDDEV 2.7.1 Rev3 or MEDDEV 2.7.1 Rev 4 clinical evaluations experience is a plus.

location: Waltham, Massachusetts

job type: Contract

salary: $48 - 60 per hour

work hours: 8am to 4pm

education: Bachelors

responsibilities:

  • Authors Clinical Evaluation Reports (CERs) and maintains/updates existing company CERs according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR.

  • Contributes toward post-market clinical safety and risk management programs as requested.

  • Critically appraises scientific literature and writes summaries for articles, products and clinical application of products

  • Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.

  • Manages timelines and communication to ensure deliverables and milestones are met.

  • Prepares for and participates in audits as needed.

  • Interacts with internal and international teams (engineering/marketing/regulatory) to define the plan and strategy for development of the Clinical Evaluation Reports for new products requiring CE Mark.

  • Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.

  • Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.

  • Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).

  • Other duties as assigned

qualifications:

  • Experience level:

  • Minimum 2 years of experience

  • Education: Bachelors

skills:

  • Technical Writing

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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