Director, CMC Authorship

Arvinas is a clinical-stage biotechnology company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being co-developed and commercialized by Arvinas and Pfizer as a potential treatment for patients with breast cancer.

#TeamArvinas is made up of more than 400 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say. For more information, please visit www.arvinas.com.

Position Summary

Arvinas is seeking an experienced individual to fill a unique position which straddles authorship of CMC-related documentation and assists in the development of CMC-strategy with respect to generating information for use in regulatory filings.  The incumbent will author, edit, and review regulatory submission sections (for IND, CTA, NDA and associated regulatory filings) to support the timely filing of both investigational and marketing applications for small molecules.  In addition, the role will help craft CMC operational strategy to gather data required to support technically complete and robust filings.  Responsibilities also include coordinating the assembly of prompt and accurate technical responses to inquiries from the FDA and other regulatory agencies on the CMC sections of regulatory documents. These tasks will be performed in close collaboration with subject matter experts, CMC Regulatory Affairs, and Quality Assurance to ensure technical precision, adherence to the regulatory strategy and requirements, as well as consistency in content within and across submissions.  The incumbent will ensure all activities are conducted with the appropriate scientific rigor and data integrity.  This is an ideal position for an individual wishing to transition from a technical lab/plant-based position into regulatory writing and sciences.

This position reports to the Sr. Vice President, Technical Operations and will be located at our headquarters in New Haven, CT or may be performed from a remote location within the U.S

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Authors scientific content for CTD Modules 2 and 3 aligned with regulatory strategy for clinical and commercial regulatory submissions
• Authors responses to health authority questions within the required timelines
• Authors precursor documents such as the Process Chemistry and Formulation Development summaries to be used as the basis for regulatory filings
• Reviews and adjudicates comments, facilitates comment resolution, revises draft sections
• Ensures content clarity/ consistency in messaging across regulation submission
• Collaborates with CMC Regulatory Affairs to ensure strategy and requirements are met
• Maintains CMC regulatory submission timelines to support project team strategies and deliverables
• Works with cross-functional teams and SMEs to ensure production of technically correct and high-quality written documents
• Drives CMC Strategy based on regulatory requirements for CTD submissions
• Interacts with appropriate departments to establish priorities and deadlines for technical documentation
• Coordinates document quality control activities with SMEs and Quality Assurance
• Coordinates the efforts of contracted writing resources to meet project deliverables and timelines
• Establishes and maintains the CMC CTD style guide
• Mentors and trains employees on the technical writing processes.

Qualifications

• 10 + years relevant experience in CMC small molecule operational roles and 5 + years of experience in authoring Modules 2 and 3.
• Must possess scientific understanding of pharmaceutical development as well as knowledge of global regulatory guidelines (ICH, Global) as eCTD requirements.
• Excellent writing skills coupled with ability to edit complex material to ensure accuracy and clarity, with conciseness.
• Demonstrated success in working in multidisciplinary teams and simultaneously working on multiple projects.
• Demonstrated ability to lead and coordinate authoring activities.
• Demonstrated ability to critically evaluate data from various CMC disciplines.
• Outstanding verbal and written communication skills, attention to detail, strong planning, collaboration, negotiating, people management skills with focus on timely delivery.
• Expert proficiency in commonly used applications like Word/Excel is required. Experience with authoring/review systems such as Please Review and Veeva RIM is desirable.
• Ability to forge cross-functional working relationships with internal and external project partners.
• Ability to be proactive in identifying issues and hurdles that may hinder the timely completion of a submission and provide appropriate solutions.

Education

• MS/Ph.D. in Organic Chemistry, Pharmaceutical Chemistry, or related technical field.

#LI-Remote

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an Equal Opportunity Employer