Clinical Regulatory Writer

Overview:

Looking for a strong Clinical Regulatory Writer with direct pharmaceutical industry experience, specifically someone who has authored regulatory documents throughout the drug development lifecycle.

Must-Have Experience

Hands-on authoring experience with clinical regulatory documents, such as:

-Clinical Study Protocols (CSPs)

-Investigator Brochures (IBs)

-Briefing Documents

-Clinical Study Reports (CSRs)

-Clinical Overviews

-Clinical Summaries (efficacy/safety)

-Health Authority responses, RFIs, and Q&A documents

-Experience supporting regulatory submissions and interacting with health authority documentation.

Ideal Candidate Profile

-5–15 years of relevant experience

-Can come from pharma or CRO environments.

-Title is less important than actual experience; Regulatory Writers or Medical Writers with the right background are acceptable.

-Minimum Master's degree in a life sciences-related field; PhD preferred but not required.

Requirements:

-Candidates who have personally authored regulatory documents, not just reviewed or QC'd them.

-Experience participating in end-to-end document development and strategic discussions.

-Ability to serve as a submission lead, collaborating with and reviewing the work of other writers.

-Strong understanding of regulatory writing strategy, not just execution.

-Someone who can contribute quickly in a fast-paced environment with minimal ramp-up.

Nice-to-Haves

-CRO experience is relevant, provided the candidate had meaningful ownership of documents.

-Medical device writers may be considered if they have exposure to drug-development documentation.

-Preclinical writers can be considered if they have worked on documents such as protocols and investigator brochures and have some exposure to clinical study reports.

Pay: $75 - $85/Hour