Associate Director – Medical Writing

Associate Director – Medical Writing

Requirements

• Ability to lead Medical Writing efforts across the organization and to develop and mentor others
• Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate, and easily understandable form
• Close attention to detail and a demonstrated concern for standards
• Strong project management and time management skills, along with initiative and ability to be productive with minimal supervision
• Ability to exercise discretion and show good judgment, demonstrate honesty and integrity, and foster and encourage trust-building behaviors
• Adaptable and flexible with excellent facilitation and team playing skills
• Knowledge of IND/NDA/BLA/MAA submission requirements and familiarity with the eCTD structure
• Excellent understanding of clinical development and industry regulatory requirements (ICH/FDA, GCP)
• Strong technological abilities, with proficiency in Microsoft Word, Excel, and PowerPoint. Strong command of routinely used business software/platforms (eg, Microsoft Office, Microsoft SharePoint, Adobe Acrobat, Veeva RIM, EndNote) is required
• Bachelor’s degree in a life sciences discipline; an advanced degree is preferred
• Minimum of 5 years as a medical writer in the pharmaceutical industry, including two years of management or de facto management level experience, or clear management potential

Responsibilities

• Lead the development of clinical/regulatory documents and other assigned tasks within established timelines with minimal supervision
• Maintain high document quality and appropriate standards for scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives (as required), are consistent with QED and industry standards, ICH/GCP guidance, and all applicable regulatory requirements
• Serve as a point of contact and initial oversight of vendors, escalating issues to management as necessary
• Represent Medical Writing on one or more programs
• Participate in the development and implementation of process improvements and/or standards within the Medical Writing function
• Provide support for health authority transparency requirements (CTR, CSR results postings)
• Assist with the development and implementation of SOPs
• Perform other duties as requested

Preferred Qualifications

• An advanced degree is preferred