Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.
Calico is seeking an Associate Director/Director, Medical Writing that will provide leadership and functional oversight for writing and leading the review/approval process of 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. The Associate Director/Director, Medical Writing functions as a strong project manager and technical leader with demonstrated scientific and customer-focused leadership skills.
Provides Medical Writing leadership for clinical programs. Acts as a medical writing subject matter expert and collaborates with Clinical Science team to deliver on clinical documentation including clinical study protocols, DSUR, Clinical Study Reports, 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 activities.
Partners with regulatory department to ensure timely completion of high-quality regulatory documents including meeting request and briefing package, and other documents as required for submissions.
Coordinates with the appropriate subject matter experts (i.e. biostatistics, nonclinical, data management) to obtain appropriate datasets to draft key documents.
Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities.
Creates document templates and style guide and lead the development of SOPs for Medical Writing processes to ensure compliance with ICH 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, and EMA regulations)
Expert ability of Microsoft Office Suite, Adobe Acrobat, and collaborative review management (SharePoint)
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 show proof of full COVID-19 vaccination and booster
Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Calico will consider requests for Reasonable Accommodations.