Vice President, Medical Writing, Regulatory
Confidential · Alameda, CA, USA ·
- Job type:
- Full Time
Vice President, Medical Writing, Regulatory
About the Company
A diverse, growing team advancing innovative drug discovery, development and commercialization efforts.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Vice President for Medical Writing in the Regulatory Science Communications division. The successful candidate will be responsible for providing expert leadership in the functional areas of scientific and regulatory writing, editing, and document quality control. This role is pivotal in ensuring the timely preparation and submission of critical regulatory documents across all stages of development, including IND/CTA, NDA/BLA/MAA, and various other regulatory submissions. The VP will be tasked with building and maintaining an effective team, overseeing the development of standards and procedures, and actively managing departmental resources to meet strategic goals. Key responsibilities also include negotiating timelines with stakeholders, identifying continuous improvement opportunities, and supervising the heads of each functional area.
Applicants for the VP position at the company should have a BS/BA, MS/MA, or PhD in a related discipline, with a minimum of 17 years of experience, or an equivalent combination of education and experience. A PhD is preferred, along with at least 7 years of specific leadership and management experience in the regulatory and scientific writing field. The ideal candidate will have a strong background in preparing complex regulatory documents, particularly for IND, NDA/BLA/MAA submissions, and be well-versed in electronic systems related to submissions. Certification in a relevant field is also preferred. The role requires a strategic thinker who can proactively assess and manage workload, engage with stakeholders, and drive continuous improvement within the department.
Functions
Operations