Director, Medical Writing

Summary

The Director, Medical Writing, within the Regulatory Affairs and Quality organization, will author high-quality, strategically aligned clinical regulatory documents supporting the regulatory requirements of clinical development programs, ensuring completeness, accuracy, and compliance.

Responsibilities

• Serves as medical writing lead on clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, and IND and NDA modules
• Collect and interpret data, analyze published literature, define problems, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions
• Represent Medical Writing in assigned project meetings and provide guidance to cross‑functional project teams as appropriate
• Serve as Medical Writing contact for external parties (for example, CROs) involved in the conduct of global clinical trials 
• Manages multiple and overlapping document timelines in a dynamic environment
• Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed
• Communicate project updates and risks to senior regulatory management and stakeholders across the organization
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Contribute to responses to requests for information from health authorities

Experience and Qualifications

• PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline
• 10 or more years of experience in Medical Writing; experience in therapeutic areas of immunology and inflammation preferred
• Ability to prepare any type of clinical regulatory document (e.g., protocol, Clinical Study Reports (CSR), Investigator’s Brochure (IB), clinical sections of Investigational Medicinal Product Dossier and Common Technical Document (IMPD and CTD/eCTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.

Skills and Abilities

• Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards
• Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization
• Ability to effectively present information and respond to questions from all levels of the organization
• Sense of urgency, focus on accuracy and accountability
• Self-starter, highly motivated, assertive, driven, and hands-on leader
• Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment
• Operate collaboratively with colleagues across functional areas in a science-driven environment
• Ability to work well under pressure and meet time sensitive deadlines
• Ability to work across locations and time zones
• Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems 
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget 
• Travel up to 10%

The expected base pay range for this position is $175,000 - $220,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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