About C4 Therapeutics:
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com.
Job Summary
C4 Therapeutics is seeking an experienced, self-motivated medical writing professional knowledgeable of the current MW landscape to lead the authoring, reviewing, QC and approval of clinical documents (e.g. protocols, IBs, CSRs) and regulatory documents (e.g briefing books) as well as supporting the creation of templates and SOPs that may be required to guide the life cycle management of medical and regulatory documents in a rapidly growing company. The Director, Medical Writing will serve as lead writer across programs/submissions that are part of the fast-paced clinical pipeline.
Your Role
- Lead activities including the authoring, review and approval of regulatory and clinical documents including but not limited to Clinical Study Protocol, Clinical Study Report, Investigator's Brochure, SOPs, briefing documents, Expedited Program applications and other clinical and regulatory documents. Participate in the creation of the strategy driving these deliverables
- Provide expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure sustainable and high-quality deliverables.
- Provide strategy and support in the best practices of medical writing for the development organization.
- Overall responsibility for planning, implementing, and adhering to medical writing timelines and budgets.
- Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in IND/NDA/MAA submission planning and documentation
- Act as Lead Medical Writer for complex studies/documents
- Strong team player and a change agent who further reinforces/enhances C4 Therapeutics’ values
- Excellent people management skills – with cross functional partners and broader organization and outside agencies
- Lead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, development of CCI, writing style guide, and support for document reviewing/authoring tools
- Experience and skill performing medical literature searches
- Developing and participating in department training and SOP development
- Performing reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed.
- Maintains cutting edge knowledge base of current developments in field and related technologies
- Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections
- Build an in-house capability, leveraging external resources as needed as the company's pipeline and business needs develop
- Ability to travel domestically
Your Background
- A self-driven, hands-on problem solver with at least 10 years’ experience in clinical medical writing in this industry (at least 8 years’ experience for Director)
- Ability to quickly onboard and take ownership of multiple trials concurrently.
- Comfortable working in a fast-paced environment and able to step into trials at any stage.
- Oncology experience required
- IND/NDA experience required
- Strong vendor and in-house team management experience required
- Advanced degree (MS, PharmD or Ph.D.) in a relevant scientific field.
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