Scientist - Medical Writer or Systematic Reviewer
The Role:
CLIN-r+ now has an exciting opportunity for a contractor Medical Writer to join our team. Are you a wizard at medical writing and systematic reviews?
Is your superpower formulating research questions, developing search strings and summarising research findings? Do you desire to work from home and setting your own hours?
Then we want to speak to you.
The role is fully remote so the ideal candidate must have mastered remote
working and have a home office set up that can deal with reviewing multiple documents.
The role initially requires a minimum of 10 hours a week availability and as the contractor masters our workflow more hours can be allocated.
This role will be in Clinical Affairs team primarily to support interesting MedTech, Invitro Diagnostic and Health Economic projects. You’ll work with subject matter experts and consultants with documentation,
but will also be an important part of the wider team.
Please state your availability on your application
Essential Skills & Experience:
- 2+ years of experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation
- 3 - 5 year’s industry experience in medical writing in the healthcare industry or academia or in related areas i.e. quality, regulatory, clinical research, or product support
- Experience with FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred
- Skilled in reference management software and word processing tools.
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
- Background or experience in MedTech, Clinical Affairs or Regulatory Affairs would be beneficiaд
Key Responsibilities:
- Performing literature reviews for specific medical devices, invitro diagnostics or health economic challenges
- Strong medical and technical writing skills
- Preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents.
- Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with clients.
- Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4).
- Knowledge of clinical research and regulatory requirements.
No agency applications please.
