Randstad Medical Writer - REMOTE in Waltham, Massachusetts
Medical Writer - REMOTE
salary:$48 - $60 per hour
date posted:Wednesday, January 13, 2021
industry:Health Care and Social Assistance
Medical Writer - REMOTE
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
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
Minimum 2 years of experience
- 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.
- Randstad Jobs