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Manager/Senior Manager, Regulatory Project Management

Location San Rafael, California
Description

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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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.

SUMMARY DESCRIPTION

The Regulatory Affairs Commercial Project Management group supports six global products with more on the horizon. We are currently seeking a Manager or Senior Manager for this dynamic group. If you have a background in Project Management with knowledge of drug development, direct experience managing commercial products and history mentoring and motivating staff, we would like to hear from you.

RESPONSIBILITIES

  • Manage, motivate, and develop Regulatory Commercial Project Management staff (provide opportunities, guidance and feedback); ensure reasonable and equitable workloads; address individual performance issues.

  • Exercise judgment within established procedures and policies to determine appropriate actions; make decisions impacting the Regulatory Project Management commercial group.

  • Identify and address conflict within RegPM to arrive at successful resolution.

  • Establish personal operational objectives; co-develop goals for staff that support department goals and business needs; contribute to formation of functional area goals.

  • Facilitate short and long-term planning activities for assigned commercial programs.

  • Analyze Regulatory Project Management commercial team processes, identify opportunities for improvement and execute process improvement initiatives across the team.

  • Analyze internal Regulatory Affairs and overall Project Management processes, identify opportunities for improvement; execute process improvement initiatives across Regulatory, individually or as a member of a team.

  • Manage Regulatory Sub-team operations for assigned commercial programs, including facilitation of Subteam and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership 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 and determine methods and procedures for creating new timelines.

  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.

  • Participate in Steering Committee and working groups for InSight Manager, representing the Regulatory Project Management commercial group; ensure staff properly maintain system.

  • Create and implement new reporting methods/reports.

  • Document project milestones/deliverables and report progress against team, department, and corporate goals.

  • Drive teams in short and long-term planning activities.

SCOPE

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.

EDUCATION

Bachelor’s degree required. Project Management Professional (PMP)® and/or Regulatory Affairs certification desirable.

EXPERIENCE

  • At least 8 years’ experience in a project management or scheduling environment; a minimum of two years’ 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.

  • Knowledge of Regulatory Affairs submissions and nomenclature desirable.

  • Exposure to electronic document management system(s) (EDMS) helpful.

  • Exposure to InSight Manager product registration tracking system helpful.

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.

About our location

San Rafael

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  • Research and Development, San Rafael, California, United StatesRemove
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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance