Director, Clinical Medical Writing

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3> <div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div> <div>&nbsp;</div> <div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div> <div>&nbsp;</div> <div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div> <div>&nbsp;</div> <div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div> <div>&nbsp;</div> <div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div> <div>&nbsp;</div> <div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><p><strong>Summary:</strong></p> <p>Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance. This position will lead medical writing activities and will manage contract writers and document QC experts, as well as workflows for document development in Veeva Vault. Key accountabilities include generating documents such as protocol, investigator brochure, informed consent form, pharmacy manual, manuscripts, clinical study reports, etc.), providing guidance on scientific and technical requirements for regulatory documents, contributing towards a style guide for Vaxcyte, and following best practices for authoring of key clinical regulatory documents to meet global regulatory standards. The Director, Clinical Medical Writing will develop new SOPs and templates and contribute towards existing SOPs to support the writing of clinical documents for clinical development activities.</p> <p>To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical writing skills and an attitude that fits our cultu