Position Description:Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents, in compliance with applicable guidelines and regulations. The successful candidate should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment. This role will function as a strong project manager and technical leader with demonstrated scientific and stakeholder-focused leadership skills.
Key Responsibilities:- Document Leadership and Authoring:
- Provides medical writing leadership for clinical programs
- Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator's Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
- 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
- Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
- Process Improvement:
- Develops medical writing best practices (e.g. standard timelines, clinical document templates, 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
Position 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, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
- 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 willing to work onsite at least 4 days a week
The estimated base salary range for this role is $230,000 - $240,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.
