Associate Director/Director, Medical Writing

Calico Life Sciences; South San Francisco (CA); On-site; USD 221,000 - 276,000; Full time

Job summary

An established industry player is on the lookout for an Associate Director/Director of Medical Writing to lead the creation and review of clinical and regulatory documents. This role requires a strong project manager with extensive experience in medical writing and knowledge of regulatory guidelines. You'll collaborate with various teams to ensure high-quality submissions and support clinical development efforts. If you thrive in a dynamic environment and are passionate about advancing healthcare through innovative writing, this opportunity is perfect for you. Join a vibrant team dedicated to making a difference in human health and aging.

Benefits

Annual cash bonuses

Qualifications

• 8+ years of medical writing experience in biotech or clinical research.
• Master’s degree in life sciences; PharmD or PhD preferred.

Responsibilities

• Lead medical writing for clinical documents and regulatory submissions.
• Collaborate with cross-functional teams and external partners.

Skills

Medical Writing

Project Management

Collaboration

Regulatory Knowledge

Communication Skills

Detail-oriented

Education

Master’s degree in life science

PharmD or PhD

Tools

Microsoft Office Suite

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/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.

Key Responsibilities:

1. 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.
2. Provides guidance to external writers on prioritization, content and timeline development, and process management, to support clinical development and regulatory activities.
3. 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.
4. 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.
5. 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.).
6. Creates clinical document templates and a Calico Style Guide.
7. 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.
8. Manages documentation of all clinical documents in document management system.

Position Requirements:

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

The estimated base salary range for this role is $221,000 - $276,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.