Director, Medical Writing bei Cardurion Pharmaceuticals, Inc.

Description

The Role:

 We are seeking a Director, Medical Writing to join our team. The Director will manage and oversee the medical writing function at Cardurion and be responsible for the efficient preparation of high quality, strategically aligned medical writing deliverables that support clinical and regulatory development activities across multiple clinical programs as well as provide oversight to outsourced medical writing activities. As an integral member of the Regulatory team, the Director actively contributes to strategic program planning and has complete oversight of medical writing deliverables. 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 all 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, and Investigator Brochures). 
• Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages and ensure accuracy, clarity, and consistency in messaging across documents. 
• Provide strategic input during document review cycles of documents 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 and stay updated on emerging regulatory guidelines and industry 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 work guidance to improve efficiency, quality, and compliance with Good Clinical Practice (GCP) and Good Documentation Practices (GDP). 
• Manage document templates for medical writing processes as needed 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 and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans. 
• 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. 

 Here’s 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, short-term and long-term disability
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks Paid Time Off annually 
• 11 company paid holidays and Year-End shut down 

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, or a combination of degrees and experience, in the pharmaceutical/biopharmaceutical industry or at 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., clinical protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs). 
• Exceptional written and verbal communication skills, with a strong understanding of clinical data and the ability to communicate complex scientific concepts clearly and effectively. 
• Proven organizational skills and the ability to manage multiple competing priorities. 
• Exceptional interpersonal and team skills to work collaboratively as part of a multidisciplinary team. 
• Expert in Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools. 
• Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. 

Pay Range

$198,900-$243,100