CER Medical Writer
1 week ago
Regulatory Submission Writer
- Ivd or medical device or pharma experience
- Proofreading on the submission
- author the submission is plus
- Working with cross-functional team
- Regulatory submission
- Product labelling
- Looking for regulatory background
- Ivdr submission, Pma, 510k submission
- Regulatory submission writing
Role Requirements and Expectations:
- The company is seeking candidates for a position in regulatory submission writing, distinct from general medical or technical writing roles.
- The main requirement is experience in regulatory submissions, specifically related to IVDR in the EU or FDA submissions in the US, such as PMA, BLA, or 510 submissions.
- Candidates with experience limited to promotional, web-based content, e-learning materials, or job aids are not suitable for this role.
- A background in editing or proofing regulatory submissions is acceptable, though the ability to write these documents is preferred.
Educational and Experience Preferences:
- While a degree in life sciences is not required, relevant experience in regulatory writing is critical.
- Applicants from diverse educational backgrounds, including journalism or English, are welcome, as long as they can effectively communicate complex information to the FDA.
- The position demands a minimum of five years of industry experience in regulatory writing. This role is not intended for individuals with only academic exposure to regulatory affairs.
Operational Details:
- The role is within the transfusion medicine organization, which deals with blood screening products. While specific product experience in blood screening isn't necessary due to its niche market, a background in in vitro diagnostics, medical devices, or pharmaceuticals is advantageous.
- This is an on-site role based in Lake County, Chicago, with no option for hybrid or remote work. Although the job description mentions the possibility of up to 5% international travel, it is unlikely for contractors.
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