Sr. Medical Writing Consultant

About Us:

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Sr. Medical Writing Consultant to join our growing South San Francisco team!

Summary:

The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

Responsibilities:

• Leads development and writing of clinical and nonclinical regulatory documents (preclinical, clinical and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/BLA modules, clinical summaries, briefing books) and summaries in accordance with predefined, aggressive timelines.
• Assists with overseeing projects assigned to CROs and other vendors including timeline development and management (e.g., Clinical Study Report review and finalization).
• Evaluates draft documents and draft statistical output for accuracy and consistency.
• Represents the function and provides status updates at internal meetings and meetings with external collaborators.
• Supports the timely generation of high-quality clinical and regulatory documentation by assuming other duties, including document editing, quality control review, and formatting.
• Assists the functional department head with developing working practices and SOPs.
• Assists in the analysis, synthesis and presentation of complex information for scientific presentations.
• Distills large amounts of clinical and scientific data into essential elements for graphical display and formulate key messages from clinical study data.
• Provides QC review support as needed and ensure consistency between related documents.
• Ability to coordinate, plan and manage communications.
• Develops and maintains medical writing processes, SOPs, templates and outlines for key documents.

Requirements:

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations regarding drug development phases, clinical research, and medical writing standards.
• Demonstrated ability to interpret and apply these guidelines to document writing.
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details.
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
• Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate.

Vaccination Requirement:

Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401K with employer matching, tuition assistance, and work life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.

Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401K with employer matching, tuition assistance, and work life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.