Associate Director/Director – Medical Writing

Associate Director/Director – Medical Writing

Requirements

• Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
• Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
• Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g., ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
• Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, and partnering with external investigators to support Investigator Initiated Study Trials, Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews
• Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g., SharePoint), and documents management (e.g., Veeva RIM)
• Experience in resource planning and management experience of contractors
• Excellent organization skills with a passion for delivering quality results
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
• Must be able to work onsite at least 4 days a week

Responsibilities

• Provides Medical Writing leadership for clinical programs, acting as a medical writing subject matter expert and collaborating with the Clinical Science team to deliver on clinical documents including Clinical Study Protocols, Clinical Study Reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews
• Provides guidance to external writers on prioritization, content and timeline development, and process management, to support clinical development and regulatory activities
• Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
• Coordinates with the appropriate subject matter experts (i.e., biostatistics, nonclinical subject matter experts, data management, clinical science, safety/pharmacovigilance, etc.) to obtain appropriate datasets to draft key documents
• Partners with the appropriate subject matter experts (clinical ops, safety/pharmacovigilance, biostats, etc.) to support protocol-related documents (i.e., Informed Consent Forms, Laboratory Manuals, Pharmacy Manuals, Dosing Diaries, Statistical Analysis Plans, etc.)
• Creates clinical document templates and a Calico Style Guide
• Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements
• Manages documentation of all clinical documents in document management system

Preferred Qualifications

No preferred qualifications provided.