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Project Manager II, Regulatory - United States  

Company managed [?] Still accepting applications

Posted on : 29 June 2017

Project Description

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.

BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. BioMarin will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.                        

SUMMARY

Our Regulatory Affairs organization, made up of a team of over 70 dedicated professionals, continues to grow. We are currently seeking an experienced Project Manager with knowledge of drug development and Regulatory Affairs 

RESPONSIBILITIES

  • Manage Regulatory Sub-team operations, including facilitation of Subteam and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting 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.

EXPERIENCE

Required Skills:

  • At least 5 years’ experience in a project management or scheduling environment; a minimum of two years’ experience managing teams and team operations.
  • 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.
  • Exposure to electronic document management system(s) (EDMS) helpful.

Desired Skills:

  • Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology. MS Project Server experience helpful
  • Knowledge of Regulatory Affairs submissions and nomenclature desirable.
  • Exposure to electronic document management system(s) (EDMS) helpful.

EDUCATION

Bachelor’s degree required.

Project Management Professional and/or Regulatory Affairs Certification a plus.

CAREER DEVELOPMENT

Next level Project Manager (II) must demonstrate exceptional leadership abilities, the capacity for critically evaluating current methods and procedures related to job function, recommending improvements, and executing resulting initiatives for Project Management group, and ability to influence and drive teams in short and long-term planning activities.  

WORK ENVIRONMENT/PHYSICAL DEMANDS

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

EOE/AA Employer/Vets/Disability

Rare Opportunities. Personal Impact.

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.