Regulatory Writer I
O
OraOphthalmic Clinical Research
Remote - USFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- 1 year of medical, regulatory, or clinical writing experience or equivalent training and work experience
- Required Skills
- Project Management
Requirements
- Master’s degree in applied or life science or communications.
- Minimum 1 year of medical, regulatory, or clinical writing experience or equivalent training.
- Ability to write, edit, and facilitate completion of clinical regulatory document types, including eCTD documents.
- Ability to analytically evaluate and interpret clinical and scientific data.
- Strong attention to detail with well-developed organization and research skills.
- Excellent communication, interpersonal, negotiation, and project management skills.
- Ability to set detailed timelines and ensure efficient, timely completion of projects.
- Demonstrated ability to multitask and achieve deadlines under time constraints.
- Strong proficiency working both in a team environment and independently.
Responsibilities
- Author and compile FDA and Ex-US regulatory applications and submissions including INDs, CTAs, protocols, and NDAs/MAAs.
- Research scientific and regulatory information for submission documents.
- Review protocol development and interpret clinical trial data for CSRs in collaboration with data management and clinical teams.
- Develop project timelines, plan regulatory milestones, and track commitments.
- Lead multiple concurrent projects with support from the Principal or Regulatory Manager.
- Format and edit regulatory documentation for inclusion in global submissions.
- Support the preparation and publication of submission documents in coordination with Regulatory Operations.
- Perform administrative duties such as maintaining trackers and filing documentation.
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