Senior Medical Writer - Medical Affairs
Location: Remote
Duration: 12 Months
Pay rate: $52/hour
3 Must haves:
• Minimum of a Bachelor's Degree required. Advanced degree strongly preferred.
• Must have an RN, MD/DO, or PharmD or 3-5 years medical device experience writing EU MDD or EU MDR Clinical Evaluation Plans / Reports
• Minimum of 3-5 years scientific writing experience.
The Medical Affairs Senior Medical Writer will combine their knowledge of science with their understanding of research and writing to present information effectively and clearly. The Senior Medical Writer will focus on scientific medical writing to prepare documents for submission to regulatory bodies. The Senior Medical writer will interface with other functions as necessary to ensure accurate and timely completion and review of documents for clinical regulatory submissions. The Senior Medical Writer will be expected to conduct comprehensive literature searches, to read and understand relevant literature, and to synthesize and summarize the relevant literature regarding subject medical devices. The Senior Medical Writer will be a resource regarding medical knowledge.
Education and Experience:
Minimum of a Bachelor's Degree required. Advanced degree strongly preferred.
Medical background (e.g., RN, MD, PharmD) required
Minimum of 3-5 years scientific writing experience.
Certification through the American Medical Writing Association (AMWA) or other relevant association is preferred.
Skills:
- Ability to write with scientific accuracy and to compile, write, edit and format documents for submission to regulatory agencies. (Writing samples required)
- Experience in conducting literature searches required
- Ability to develop and conduct comprehensive literature searches i.e., interpret / summarize / synthesize relevant literature)
- Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.
- Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines
- Excellent written and verbal communication skills.
- Superior attention to detail.
- Proficiency in MS Office with expertise in Microsoft Word with a special focus on word processing, use of templates, and formatting. Working knowledge of Excel.
- Proficiency with a PC
- Excellent time management skills, and ability to meet deadlines
- Working knowledge of statistical concepts and techniques.
- Experience in working with collaborative, cross-functional teams.
- Ability to function well both individually and as part of a team.
- Experience in working with collaborative, cross-functional teams.
- Ability to function well both individually and as part of a team.
- Experience in working with collaborative, cross-functional teams.
- Ability to function well both individually and as part of a team.
- Experience in working with collaborative, cross functional teams
- Ability to function well both individually and as part of a team
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Last updated on Oct 7, 2020