We have a current opportunity for a Sr Project Operations Manager - on a contract basis. The position will be based in Novato. For further information about this position please apply.
Support the Global R&D and Regulatory Policy Team in the following policy activities:
- Monitor, review and inform stakeholders on recently published global regulatory policies and guidance documents impacting drug development - and of treatments for rare diseases and advanced therapies.
- Provide project management support to the policy team in generation of comments on draft guidance.
- Contributing as needed to all types of internal reporting (ad hoc memos, weekly summaries, highlights, digests etc.)
- If required, representing BioMarin on trade association calls and meetings, and generate minutes for the benefit of the global head or regional leads.
- If required, attending external scientific and regulatory conferences, typically virtually, ensuring key intelligence and highlights are shared with the team and the rest of the organization.
- Supporting the preparation and follow-up of internal meetings with stakeholders and SMEs.
- Updating the team's trackers, engagement maps and SharePoint.
- Monitoring and documenting progression of the team objectives and key results (OKRs).
- Track Team memberships and involvement in policy trade associations and organizations.
Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.
Work experience in regulatory policy, or project or program management; a minimum of two years' experience managing teams and team operations desired.
Thorough understanding of the regulatory environment is a bonus.
Regulatory agency experience, or experience in an industry trade organization is ideal but not an absolute prerequisite.
Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.
Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.
The candidate should possess the ability to work as part of an interdisciplinary team spread across different time zones, have strong organizational skills, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.
Strong attention to detail.
Bachelor's or Master's degree in biology or other life sciences discipline.
Project Management Professional would be helpful.