Associate Director, Medical Writing

Calico Life Sciences; South San Francisco (CA); On-site; USD 230,000 - 240,000; Full time

Benefits offered by this job

Two annual cash bonuses

Onsite work environment

Job summary

A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing at a biotech or pharmaceutical company. Responsibilities include document leadership, vendor management, and process improvement. A strong understanding of regulatory requirements and excellent communication skills are essential. The estimated salary range is $230,000 - $240,000 with additional bonuses.

Qualifications

• Minimum 8+ years of experience in scientific or medical writing.
• Expert knowledge of clinical regulatory document types.
• Excellent organizational skills with quality results.
• Self-motivated, collaborative, with a positive attitude.

Responsibilities

• Lead medical writing for clinical programs and documents.
• Ensure high-quality regulatory submissions.
• Develop medical writing best practices.

Skills

Scientific or medical writing

Regulatory document knowledge

Microsoft Office Suite

Detail-oriented mindset

Excellent communication skills

Education

Master’s degree in life science

PharmD or PhD preferred

Tools

Adobe Acrobat

SharePoint

Veeva RIM

Job description

Who We Are

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.

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.