Principal Regulatory Writer

Job Overview:

Regulatory Writers prepare high-quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of documents across different service lines.   The PRW will be the project leader and authoring contributor for all types of client engagements while mentoring others in the knowledge of authoring regulatory documents.

At least 7 years’ experience actively writing regulatory documents.

• Worked as the lead writer on >5 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications, PSUR or DSUR, PBRER, RMP, or PIP.
• Experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC]).
• Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
• Ability and willingness to take on any project for which a Lead Writer is needed.
• Competency in the use of document management systems and associated tools.

In addition to having the above writing experience, applicants must have:

• Masters/Bachelors degree in science/pharmacy (PhD not necessary).
• Fluent written and spoken English skills.
• An appreciation for a well written document and an eye for details.
• Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
• Flexibility and the ability to stay focused under tight timelines.