Regulatory Writer, Regulatory Affairs and Quality Assurance - Core Logic, Inc.

Position Description

Description:

The Regulatory Writer will assist in the production of regulatory (i.e., non-clinical, CMC, clinical) documentation required by regulatory agencies for IND/CTA and NDA/MAA submissions. Regulatory documentation responsibilities begin with establishment of the appropriate document format, or template, and content guidelines to support worldwide regulatory submissions. Documentation templates range from Briefing Packages, Investigator Brochures, Investigational Medicinal Product Dossier, Protocols, Clinical Study Reports and Summary (ISS, ISE) reports, as well as EU Expert Reports. The Regulatory Writer will be responsible for the establishment and writing/updating of other regulatory support documents, including the Target Product Profile, Core Data Sheet and labeling (package insert). The Regulatory Writer will also participate in submission specific sub-teams focused on regulatory submissions (i.e., IND/CTA; NDA/MAA; Health Authority Response, etc).

The Regulatory Writer will work cross functionally to establish efficient processes that ensure high quality documents and compliance with strict regulatory and company guidelines. To accomplish this, the Regulatory Writer will collaborate with other Medical Writers to ensure that the regulatory documentation format used is correct and the content is consistent with agreed upon “messaging.”

Qualifications:

Candidates must have a Ph.D. in a science-related field and at least 5 years of drug development/regulatory experience in project management/submissions. A clear understanding of submission content and format required by US and non-US regulatory agencies is required. Demonstrated experience in the development of documents in eCTD format that meet submission requirements for regulatory applications is a must. Candidates must be proficient in Microsoft Office and a document management system, preferably Master Control, as well as a standard industry publishing tool such as ISIWriter. Outstanding communication, both oral and written, and human relations skills are also required.

Compensation:
100K -120K
Please send a writing sample along with resume
Prefer someone local


Please note: Position is specific to Regulatory Writers not Medical Writers.

How to Apply

Application Instructions / Send a Resume