Associate Director, Medical Writing

Cynosure Staffing; South San Francisco (CA); On-site; USD 230,000 - 240,000; Full time

Job summary

Cynosure Staffing in California is seeking an Associate Director, Medical Writing to lead and oversee the creation and review of high-quality clinical and regulatory documents in compliance with ICH and global guidelines.

The role emphasizes project leadership, cross-functional collaboration with Clinical Science, Regulatory, and QA, plus hands-on writing for protocols, CSRs, DSURs, IBs, and CTD components; onsite four days weekly.

Qualifications

• Master's degree in life science; PharmD or PhD preferred.
• 8+ years of scientific or medical writing experience in biotech/pharma or CRO.
• Expert knowledge of ICH guidelines and global regulatory requirements.
• Experience writing CSPS/SSRS, DSURs, IBs, CTD components, and IND summaries.
• Experience in resource planning and managing contractors.
• Willing to work onsite at least 4 days a week.

Responsibilities

• Provides medical writing leadership for clinical programs.
• Delivers clinical/regulatory documents including protocols, CSRs, DSURs, and CTD modules.
• Collaborates with regulatory to prepare submissions and briefing packages.
• Guides external writers on content, prioritization, and timelines.
• Develops SOPs with QA to ensure ICH compliance.

Skills

Medical writing leadership

Project management

Regulatory writing

Stakeholder collaboration

Education

Master's degree in life science

PharmD or PhD preferred

Tools

Job description

The Company:

A clinical-stage biotechnology organization focused on aging, and age-related diseases.

The Role:

The full-time 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

• 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


• 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.

Experience And Qualifications

• 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


• Experience in resource planning and management experience of contractors


• 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