Director - Clinical Medical Writing

January 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $218k - $244k / year

⏰ Full Time

🔴 Lead

✏️ Content Writer

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Vaxcyte

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Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Join our Mission to Protect Humankind! • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. • Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella. • Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies. • This position will lead medical writing activities and manage contract writers and document QC experts. • Key accountabilities include generating documents such as protocol, investigator brochure, informed consent form, pharmacy manual, manuscripts, clinical study reports, etc. • Provide guidance on scientific and technical requirements for regulatory documents. • Follow best practices for authoring of key clinical regulatory documents to meet global regulatory standards. • Develop new SOPs and templates and contribute towards existing SOPs for clinical development activities.

🎯 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 lead writer 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 develop and implement medical writing processes and standards. • Strong computer skills, project management skills, and a high attention to detail. • Experience with Zoom and Veeva Vault, preferred. • Strong communication skills (both written and oral). • Strong organizational abilities and experience in a multitasking environment. • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission. • Expert-level skills w/ Microsoft Word and PowerPoint; and competent with other Microsoft Office 365 apps. • Ability to travel up to 30% domestic and international. • Strong team player that models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

🏖️ Benefits

• Comprehensive benefits package • Equity component