Associate Director, Medical Writing

External

Calicolabs · South San Francisco, CA

$230K–$240K/yrFull-timeOn-site3w ago

ComplianceLeadershipProcess ImprovementVendor Management

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About the role

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. 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.

Responsibilities

Document Leadership and Authoring:

Provides medical writing leadership for clinical programs

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.

Associate Director, Medical Writing

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