Vaxcyte
Director, Clinical Medical Writing
San Carlos, California, United States · Director
Sponsorship not specified$221k-$258kDetected 21 days ago
GCPProject ManagementForecastingClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationWritingMicrosoft Office
About the role
- 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.
Responsibilities
- Provide expertise and leadership in the development of regulatory and clinical documents, including the processes and templates that will ensure sustainable and high-quality deliverables.
- Lead clinical study documentation including but not limited to clinical protocols, investigator brochures, informed consents, various study plans, and clinical study reports.
- Lead cross-functional team discussions to support the development of the above noted clinical trial documents for IND submissions and execution of clinical trials.
- Manage document generation 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 embed quality and GCP compliance within day-to-day activities.
- Proactively identify risks and develop and implement mitigation strategies.
Requirements
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
- Strong organizational abilities and experience in a multitasking environment.
Nice to have
- Preferred clinical writing experience in clinical vaccine development, with Phase I-III and Phase IV post-marketing experience.
- Experience managing writing activities for a major US or international regulatory submission (project or people management preferred).
- Experience with Zoom and Veeva Vault, preferred.
- and competent with other Microsoft Office 365 apps, and Veeva Vault.
- Expert-level skills w/ Microsoft Word and PowerPoint
Compensation
- $221,000 - $258,000 (SF Bay Area). Salary ranges for non-California locations may vary.
- The compensation package will be competitive and includes comprehensive benefits and an equity component.
Benefits
- Provide strategy and support in the best practices of medical writing for the development organization.
- Participate in the selection and oversight of vendors contracted for medical writing services.
- Represent Clinical Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in BLA/NDA submission planning and documentation.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Company info
- Join our Mission to Protect Humankind!
Equal opportunity
- We are an equal opportunity employer.
- equal opportunity employer.
Apply directly at Vaxcyte →Create a free account for alerts like thisView Vaxcyte immigration profile
This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.