Arvinas is a clinical-stage biopharmaceutical 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 two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 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 purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
Arvinas is seeking an experienced individual with CMC technical writing experience for authoring, editing, and reviewing regulatory submission sections (for IND, CTA, NDA and associated regulatory filings) to support the timely submission of both investigational and marketing applications for small molecules. 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 position reports to the 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.
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
- 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
- Authors precursor documents such as the Process Book or Formulation Binder to be used as the basis for regulatory filings
- 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.
- An MS/Ph.D in Organic Chemistry, Pharmaceutical Chemistry, or related technical field, with 5 + years relevant experience in CMC operational roles and 10 + 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 well 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 Vault 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.
- An MS/Ph.D in Organic Chemistry, Pharmaceutical Chemistry, or related technical field.