Massachusetts Healthcare Jobs

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.