Vice President, CMC Regulatory Affairs
Iovance Biotherapeutics, Inc.
Associate Principal / Principal Medical Writer
Trilogy
full-time
Posted on:
Location: North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $159,000 per year
Job Level
JuniorMid-Level
About the role
- Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications)
- Collaborate with members of client authoring teams and be supported by other writers as appropriate
- Ensure documents are produced according to agreed timelines and adhere to relevant SOPs
- Monitor and manage project budgets and meet client requirements
- Provide document-specific advice to clients
- Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility
- Project manage the timelines and review cycles of your documents
- Work in the client’s regulatory document management systems
- Serve as an integral member of clinical development teams supporting writing and coordination across therapeutic areas
Requirements
- At least 5 years of experience of actively writing regulatory documents
- Experience as a lead writer on CTD documents is required
- Must have worked as the lead writer on Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications
- Experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight
- Must be able to manage multiple projects simultaneously
- In-depth working knowledge of relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance
- Experience in multiple therapeutic areas
- Advanced understanding of and ability to apply statistical, regulatory, and medical communication concepts to independently write complex regulatory documents
- Competency in the use of document management systems and review tools
- Minimum of a Bachelor’s degree in science/pharmacy (Ph.D. not necessary)
- Fluent written and spoken English skills
- Appreciation for a well-written document and an eye for detail
- Excellent, proven interpersonal skills and ability to proactively participate on a diverse team
- Flexibility and the ability to stay focused under tight timelines
- Applicants must live in the US and be authorized to work for any employer in the US (unable to sponsor or take over sponsorship)
