This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking an Associate Director, Regulatory CMC Writer who will work collaboratively with the CMC Regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs. You will draft, review, and finalize CMC content and CMC modules for INDs, CTAs, BLAs and other filings. This company offers innovative science, a patient-focused company culture, and the ability to work remotely. With their first rolling BLA in progress, now is an exciting time to join this innovative organization!
Responsibilities:
- Author CMC sections for filing and maintenance of INDs, CTAs, IMPDs, BLAs, MAAs, ROW submissions, and CMC source documents for T Cell based immunotherapy programs.
- Collaborate with Regulatory CMC Product Lead to execute CMC Submission and Authoring strategy for assigned projects.
- Proactively plan and manage writing activities across assigned projects as appropriate, ensuring adherence to the technical writing strategy and alignment with regulatory/Health Authority requirements.
- Ensure communications are complete, well organized, and scientifically accurate, and that messaging is consistent throughout all technical documentation including Briefing Documents, Quality Amendments, Module 2 and Module 3 updates, Annual Reports, etc.
- Contribute to therapeutic project teams as the technical writing expert for CMC regulatory submission documents.
- Work closely with stakeholders to support corporate and departmental objectives.
- Adhere to writing practices/systems/tools to support CMC documentation to meet company goals and objectives.
- Assure that standardized practices are implemented and maintained across regulatory documents.
- Ensure writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulation.
- Create and maintain core dossier and CMC Authoring templates.
- Collaborate with Regulatory Operations to insure timely and accurate submissions
- Critically review the source documents for consistency, completeness, and quality.
Qualifications:
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Six or more years of pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and Regulatory CMC writing for biologics.
- Regulatory CMC writing experience with cell therapy programs, proteins, and monoclonal antibodies preferred.
- Demonstrated expertise in writing/developing CMC content in Briefing Documents, Quality Amendments, Module 2 and Module 3 updates and CMC source documents in support of US and global regulatory submissions Understanding of biological lifecycle drug development
- Experience with ICH, CTD and electronic submission guidelines for regulatory reports.
- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies (e.g. Veeva Vault)
- Proven track record with project management and experience with GDP, GCP, and GMP. Ability to handle multiple projects simultaneously.
- Excellent written and verbal skills. Excellent attention to accuracy and detail.
- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Strong organizational and planning skills along with outstanding written and verbal communication skills.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
The budgeted salary range for this position is $190,000 to $210,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.