Hawkins Point Partners Senior R&D Program Manager in Cambridge, Massachusetts
Hawkins Point Partners has an immediate need on its team for a Senior Program Manager with expertise supporting an integration project within Global Regulatory Affairs with extensive knowledge of Veeva Vault.
The ideal candidate will have strong leadership skills and perform as a trusted advisor between business and software vendor partners. He/she will manage diverse groups, align and define objectives. The ideal candidate must have past experience working on global projects and possessing some knowledge of R&D in the pharmaceutical. Strong project coordination and facilitation skills are a must. Ideal candidate will have experience supporting global enterprise systems and a strong knowledge of global regulatory affairs.
Eight years of Information technology management experience supporting 21 CFR Part 11 regulatory environments.
Extensive knowledge of Veeva Vault is a must.
Deep understanding of Global Regulatory Affairs
Experience supporting business sponsors and managing project scope, project risk mitigation, cost, schedule, internal staffing and outside vendors/contractual deliverables.
Some knowledge of R&D in the pharma industry is required
Experience in GRA, submission publishing, and document management is preferred but not required
Strong attention to detail and documentation tracking skills. Ability to provide reports for upper management regarding status of project.
Team building and strong customer service skills along with vendor management skills.
GRA experience is highly desired
Documentum and FirstDoc experience is desired
eCTDXPress experience is desired
Bachelor of science or related advanced educational degree.
At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.