What are the responsibilities and job description for the Regulatory Project Manager I (TEMPORARY) position at BioMarin?
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.
Project Management Professional and/or Regulatory Affairs Certification a plus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S, the salary range for this position is $ null to $ null per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
In the U.S., the salary range for this position is $ null to $ null per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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.
Job Details
Edit
Job Category
Regulatory
Job Title
Regulatory Project Manager I
Job Code
Project Manager, Business Technology Management I
Duties
Manage Global Regulatory Team operations, including facilitation of GRT and Regulatory Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting facilitation and leadership often required).
Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
Document project milestones/deliverables and report progress against team, department, and corporate goals.
Facilitate short and long-term planning activities.
Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.
Coordination across multiple departments: Clinical Sciences, Global Project Management, Commercial, PharmSci, CMC/TOPS, Biostats, etc.
Skills
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
2-5 years of experience in a project management or scheduling environment; a minimum of two years of experience managing teams and team operations.
Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology. MS Project Server experience helpful.
Pharma/biotech or related industry experience required.
Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
Education
Bachelor’s degree required.
Project Management Professional and/or Regulatory Affairs Certification a plus.
Skills and Experience
The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
In the U.S, the salary range for this position is $ null to $ null per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
In the U.S., the salary range for this position is $ null to $ null per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
