Senior Project Operations Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
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 in particular.
- Provide project management support to the policy team in generation of comments on draft guidance.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.
- Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
- Lead certain policy cross-functional meetings including minutes and action items.
- Provide strategic logistical support for managing policy calendars and deliverables.
- Develop and manage internal policy publications.
- Develop and manage dashboards for policy team initiatives.
- Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
- Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
- Manage Trade Association List and Memberships including main contacts.
- Document project milestones/deliverables and report progress against team, department, and corporate goals.
- Create and maintain project timelines for key activities and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.
- Create and maintain program-specific risk assessment dashboards and management framework.
- Manage R&D and regulatory policy meetings where projects will be discussed (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership may be required).
- Provide project management support for cross functional meetings including program planning, key action items, and progress on deliverables.
- 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.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.