Associate Director, Medical Writing

AVENZO THERAPEUTICS INC • San Diego, CA

5d • Onsite

About The Position

Reporting to the Director, Medical Writing, the Associate Director, Medical Writing will author, edit and provide input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. They may also author, edit and direct the development of pre-clinical documents. The candidate will ideally have a background in drugs and biologics. Experienced, independent medical writers who have worked with cross-functional program teams and want to be part of the next generation of cancer therapies at a growing company should apply.

Requirements

• Bachelor’s degree required, PhD in advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 8+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Extensive recent hands-on oncology experience, preferably within targeted oncology programs
• Demonstrated, recent hands-on experience authoring regulatory designation submissions from inception, including Orphan Drug, Fast Track and Breakthrough Therapy applications
• Proven experience preparing US and global health authority documents from scratch including meeting requests, briefing books and responses to regulatory requests for information
• Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA)regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Awareness of regulations pertaining to clinical trial disclosure and data sharing
• Experience with relationship management and oversight of medical writing activities carried out by CROs and vendors
• Exceptional ability to communicate highly complex ideas
• Expert in facilitating discussions to bring cross functional teams into alignment regarding the content of clinical documents
• Experience communicating timeline expectations with cross-functional study team members
• Experience with electronic document management systems
• Highly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPoint
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Responsibilities

• Serve as the lead medical writer on multiple clinical programs
• Coordinate preparation of application packages, including Investigational New Drug (IND) applications including life cycle management, Clinical Trial Applications (Ex-US), and New Drug Applications (NDAs)
• Develop, align, coordinate, and build consistent information and messages across regulatory documents within a global clinical program
• Ensure all documents across programs are planned, developed, managed, reviewed, quality checked, and approved according to mutually agreed timelines with input from all critical stakeholders
• Collaborate with cross functional teams on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, investigator’s brochures, annual reports, publications (manuscripts, abstracts, poster presentations, etc.), and other documents as needed
• Ensure that the content of each document is clear, concise, strategic, well-positioned for public disclosure, meets scientific standards and complies with regulatory guidelines
• Assist in developing and maintaining SOPs
• Provide guidance on medical writing templates, QC Procedures, SOPs, and processes within and across departments
• Take the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
• Other duties as assigned

Benefits

• employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
• short-term and long-term disability insurance, flexible spending accounts, health savings account, and voluntary insurance programs including voluntary life and AD&D accident, and critical illness
• company’s 401(k) plan
• 10 hours of paid vacation time every month, and accrue 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays, including a winter closure, throughout the calendar year
• Regular, full-time employees are eligible for up to 8 weeks of paid parental and/or medical leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director