Director, Clinical Medical Writing

Related keywords: medical writer remote jobremote job san franciscomedical remote job

This page contains product affiliate links.

Company Overview

Vaxcyte is a prominent clinical-stage vaccine innovation company that focuses on creating high-fidelity vaccines aimed at protecting human health from bacterial diseases. The company's mission is to eliminate the serious consequences that arise from untreated bacterial infections, such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Vaxcyte is built on four core values that drive its operations: Rethink Convention, Aim High, Lead with Heart, and Model Excellence. These values emphasize collaboration, innovation, high standards, and a commitment to improving health outcomes.

Job Overview

Vaxcyte is seeking a Director of Clinical Medical Writing. This key role will shape and drive the medical writing processes and strategies within the company. The Director will be responsible for overseeing the generation and maintenance of clinical documents necessary for regulatory submissions and clinical trials. This includes managing a team of contract writers and quality control experts and guiding all aspects of medical writing activities.

A successful candidate must be an exceptional communicator and collaborator, possessing strong clinical writing skills and the ability to thrive in a fast-paced, high-growth environment.

Key Responsibilities

The primary responsibilities of the Director of Clinical Medical Writing include:

  • Leading the development of crucial clinical documents such as protocols, investigator brochures, informed consent forms, pharmacy manuals, and clinical study reports.
  • Providing guidance regarding scientific and technical requirements for regulatory documents while maintaining compliance with global standards.
  • Generating and maintaining new Standard Operating Procedures (SOPs) and templates essential for the writing process.
  • Overseeing cross-functional team discussions to develop necessary clinical trial documents for IND submissions and the execution of clinical trials.
  • Participating in discussions related to budget forecasting and financial management of writing activities.
  • Championing an inclusive mindset while fostering collaboration among various departments within the organization.

Required Skills and Qualifications

To qualify for the position, candidates should possess the following experience and qualifications:

  • Clinical writing experience in vaccine development, particularly in Phase I-III and Phase IV post-marketing activities, is preferred.
  • An advanced degree (Ph.D. or PharmD) is highly desirable, along with a minimum of 12 years of medical writing experience within the biotechnology or clinical research sector.
  • Proven track record as a lead writer for critical documents for major US and/or international regulatory submissions.
  • Familiarity with tools like Zoom and Veeva Vault, preferred but not mandatory.
  • Exceptional organizational abilities and experience handling diverse tasks in a multitasking environment.
  • Proficiency in Microsoft Word and PowerPoint, along with familiarity with other Microsoft Office 365 applications.
  • Strong project management skills and meticulous attention to detail.
  • Ability to travel domestically and internationally up to 30% of the time.

Compensation and Benefits

Vaxcyte offers a competitive compensation package that includes comprehensive benefits as well as an equity component. The salary range for this position is between $218,000 and $244,000, particularly for positions based in the San Francisco Bay Area; however, the salary may vary for roles outside California.



The company is committed to ensuring that all applicants receive fair consideration for employment without discrimination based on race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.

Application Process

Candidates interested in this opportunity at Vaxcyte should prepare their application by highlighting their relevant experience, emphasizing their alignment with the company's core values, and showcasing their capacity to take on a leadership role in clinical medical writing.

In conclusion, this position at Vaxcyte presents a unique opportunity for experienced professionals in the medical writing field who are eager to contribute to groundbreaking work in vaccine development. The role not only demands a high level of expertise but also encourages a culture of inclusivity and collaboration, ensuring that the successful candidate will find a meaningful and impactful career path within a company dedicated to innovative healthcare solutions.



This job offer was originally published on remotive.com

Vaxcyte

USA

Web content writing

Full-time

February 3, 2025

6 views

0 clicks on Apply Now

Share


Similar job offers


This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.