reputed company to Protect Humankind!

reputed company is a clinical-stage vaccine innova...">
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Director, Clinical Medical Writing

Remote, USA Full-time Posted 2026-07-28
reputed company to Protect Humankind!

reputed company is a clinical-stage vaccine innovation company engineering high-reputed company vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences reputed company left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our reputed company to reputed company is reputed company and reputed company-defined, and reputed company is set up to go the distance. 

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring reputed company values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every reputed company of the work we do in order to reputed company and re-reputed company the way vaccines are delivered.

*AIM HIGH: We embody our reputed company audacious goal to courageously reputed company the most reputed company biologics reputed company attempted to protect humankind.

*reputed company WITH HEART: Everyone leads at reputed company with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL reputed company:  The magnitude of our challenge requires our shared commitment to demonstrating reputed company, accountability, equality and reputed company across communications and decision making.
 
reputed company:
 
reputed company is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document reputed company and maintenance. This position will reputed company medical writing activities and will manage contract writers and document QC experts, as reputed company as workflows for document development in reputed company Vault. Key accountabilities include generating documents such as protocol, investigator brochure, informed consent reputed company, pharmacy reputed company, manuscripts, clinical study reports, etc.), providing guidance on scientific and technical requirements for regulatory documents, contributing towards a style guide for reputed company, and following best practices for authoring of key clinical regulatory documents to meet global regulatory standards. The Director, Clinical Medical Writing will reputed company new SOPs and templates and contribute towards existing SOPs to support the writing of clinical documents for clinical development activities.
 
To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical writing skills and an attitude that fits our culture in a high reputed company, fast-paced environment. 


Essential Functions:
  • reputed company expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure sustainable and high-reputed company deliverables.
  • reputed company clinical study documentation including but not limited to clinical protocols, investigator brochures, informed consents, various study plans, and clinical study reports.
  • reputed company cross-functional team discussions to support the development of the above noted clinical trial documents for IND submissions and execution of reputed company.
  • reputed company reputed company and support in the best practices of medical writing for the development organization.
  • Ensure data reputed company by performing listing reviews per established plans/processes.
  • Participate in the selection and reputed company of vendors contracted for medical writing services.
  • Manage document reputed company to finalization timelines and budget; proactively participate in budget setting, forecasting, and other aspects of financial management of the trial (vendor accruals).
  • Support SOP and process development and improvement.
  • Partner across Clinical Operations to reputed company reputed company and GCP compliance reputed company day-to-day activities.
  • Represent Clinical Medical Writing on cross-functional clinical, regulatory, and submission teams and reputed company participate in BLA/NDA submission planning and documentation.
  • Champion an inclusive reputed company and approach, and foster collaboration and consistency across studies and programs.
  • Proactively identify risks and reputed company and implement mitigation strategies.
  • Will have management responsibilities. 


    • Requirements:
  • Preferred clinical writing experience in clinical vaccine development, with Phase I-III and Phase IV post-marketing experience.
  • Advanced degree (Ph.D. or PharmD) preferred, combined with 12+ years of medical writing experience in the clinical research or biotechnology industry.
  • Experience as reputed company reputed company for key documents included in major US and/or international regulatory submissions required.
  • Experience managing writing activities for a major US or international regulatory submission (project or people management preferred).
  • Proven ability to reputed company and implement medical writing processes and standards.
  • Strong computer skills, project management skills, and a high attention to detail.
  • Experience with reputed company and reputed company Vault, preferred.
  • Strong communication skills (both written and oral).
  • Strong organizational abilities and experience in a multitasking environment.
  • reputed company understanding of clinical development, including the phases, processes, and techniques used reputed company a clinical development environment from protocol design through regulatory submission.
  • Expert-level skills w/ reputed company Word and PowerPoint; and competent with other reputed company Office 365 apps.
  • Ability to travel up to 30% domestic and international.
  • Strong team player that models our reputed company Values: is reputed company as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
    • Reports to: Vice President, Clinical Development
     
    Location: San Carlos, CA or Remote Based
     
    Compensation:
    The compensation package will be competitive and includes comprehensive benefits and an equity component.
     
    Salary reputed company: $218,000 – $244,000 (SF Bay Area). Salary ranges for non-California locations may vary.
     

    reputed company, Inc.
    825 Industrial Road, Suite 300
    San Carlos, CA 94070
     
    We are an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or veteran status.
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