Regulatory Writer Job at Virtual Vocations Inc, United States

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  • Virtual Vocations Inc
  • United States

Job Description

Working remotely, the full-time Regulatory Writer I will research, write, and edit materials for regulatory submissions to the FDA, collaborating with cross-functional teams to support clinical programs from pre-clinical to Phase 4 trials. Key responsibilities Author and compile FDA and Ex-US regulatory applications and submissions, including INDs, CTAs, and NDAs/MAAs Assist in researching scientific and regulatory information to write submission documents and interpret clinical trial data Contribute to project timelines and regulatory milestones while managing multiple concurrent projects Required qualifications Master's degree in applied or life science or communications 1 year of medical, regulatory, or clinical writing experience or equivalent training Ability to write and edit clinical regulatory documents, including eCTD documents Strong organizational and time management skills to handle multiple projects simultaneously Ability to work effectively in a team environment and independently

Job Tags

Full time, Remote work

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