🚀 Director, Medical Writing

Director, Medical Writing – Cardurion Pharmaceuticals

We are seeking a Director, Medical Writing to lead the medical writing function at Cardurion and oversee the preparation of high-quality, strategically aligned medical writing deliverables that support clinical and regulatory development across multiple programs. The Director will provide oversight to outsourced medical writing activities and contribute to strategic program planning as a key member of the Regulatory team. This position reports to the Vice President, Regulatory Affairs.

Here’s What You’ll Do

• Develop and implement medical writing strategies and operational plans across clinical development programs.
• Provide medical writing leadership and support for regulatory submissions.
• Build effective partnerships with cross-functional teams (e.g., program leadership, regulatory affairs, clinical development, biometrics) and represent the medical writing function in cross-functional team meetings to ensure timely delivery of documents.
• Author or oversee the creation of high-quality clinical and regulatory documents (e.g., protocols, clinical study reports, briefing books, INDs/CTAs, NDAs, Investigator Brochures).
• Apply expert medical writing proficiency to lead planning and authoring of complex, strategic clinical and regulatory documents and submission packages, ensuring accuracy, clarity, and consistency in messaging.
• Provide strategic input during document review cycles and guide teams through resolution processes.
• Initiate and drive strategic medical writing initiatives with high technical acumen to ensure execution on company priorities.
• Ensure compliance with global regulatory requirements (e.g., ICH guidelines) and industry standards in all written materials; stay updated on emerging regulatory guidelines and best practices related to medical writing.
• Support clinical trial transparency efforts by managing disclosures on platforms like ClinicalTrials.gov and EudraCT.
• Establish and maintain medical writing processes, policies, standard operating procedures, training and guidance to improve efficiency, quality, and GDP/GCP compliance.
• Manage document templates for medical writing processes to ensure consistency across projects.
• Work collaboratively with subject matter experts to integrate scientific content into documents.
• Oversee contract medical writing resource allocation for internal teams and external vendors based on project needs.
• Develop short- and long-term objectives for the function aligned with overall company strategies.
• Plan and manage budget proposals and approved budgets in accordance with the company’s strategic and operating plans and finance policies.
• Some travel may be required.

What We’ll Bring To The Table

• Highly competitive benefits package including Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
• Fully funded HSA for high-deductible PPO Plan
• 401k (traditional and Roth offered) with 100% match on first 4% deferred; match is vested immediately
• A suite of Cardurion paid insurance coverage, including life insurance and disability (short-term and long-term)
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks Paid Time Off annually
• 11 company paid holidays and Year-End shutdown

Requirements

Here’s What You’ll Bring to the Table

• A Bachelor’s, Master’s, or PhD in a scientific, medical, or clinical discipline.
• 10+ years of industry regulatory writing and clinical medical writing experience.
• 5+ years of management experience in the pharmaceutical/biopharmaceutical industry or a clinical contract research organization (CRO).
• Strong understanding of global regulatory requirements (FDA, EMA, Health Canada, and ICH guidelines) for clinical trial documentation and transparency.
• Extensive experience writing regulatory submission documents across all phases of drug development (e.g., protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs).
• Exceptional written and verbal communication skills with ability to convey complex scientific concepts clearly.
• Proven organizational skills and ability to manage multiple priorities.
• Exceptional interpersonal and teamwork skills for multidisciplinary collaboration.
• Expert knowledge of Microsoft Word, Excel, PowerPoint, and related tools.
• Expert knowledge of document content preparation, style guides, medical dictionaries, regulatory guidance documents and templates.

Our mission: Translate world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.

Cardurion is an equal employment opportunity employer. We do not discriminate based on race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any other protected characteristic. Cardurion provides reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.