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Back To Current Job Listings: Sr. Project Coordinator, Regulatory Affairs
Sr. Project Coordinator, Regulatory Affairs
[Aug 16, 2019]

JOB SUMMARY:

Under supervision of the Senior Director, Regulatory Affairs, the Senior Project Coordinator – Regulatory Affairs will coordinate cross-functional project teams, including internal and external, to drive development; establish project plans with milestones and deliverables.  The Senior Project Coordinator – Regulatory Affairs will support the Regulatory Affairs department by managing department metrics, compile and publish ANDAs in eCTD format, and create and revise labeling,

  

DUTIES AND RESPONSIBILITES:

Coordinates with manufacturing partner, development partner and Breckenridge to ensure timely launch of new products to the US market.

·       Coordinates all aspects of the development relationship between the partner and the organization to ensure the timely achievement of milestones in accordance with the applicable agreement.

Coordinates project team meetings, prepares meeting agendas and minutes as well as diligently follows up on all action items.

Actively manages issues and risks to allow the projects to move forward.  Develops alternative scenarios, with the project team, to address deviations to the plan.

 

Monitors, record and report progress of project activities and milestones.  Tracks, monitors and reports project timelines against established baseline milestones.

 

Independently compile and publish ANDAs in eCTD format in preparation for transmittal through FDA gateway by the Manager/Director.   Compilation includes creating eCTD backbone and performing document preparation through hyperlinks and bookmarks.

 

Create, revise and maintain product labeling including, but not limited to, labels, outserts, cartons, and medication guides per FDA regulations/guidance’s and BPI SOPs.  Draft labeling includes MSWord and PDF copies, annotated (side-by-side) labeling as well as working with external sources to create draft printer proofs, as required. 

·        Maintain project-related content on Wrike, and manage core team lists.

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE:

BS required (preferably in a science –Biology, Chemistry or Pharmacy); graduate degree a plus.

 

Project Management Certification (PMP, PgMP or CAPM) is preferred.

 

Must possess excellent verbal and written skills.

 

Proficient understanding of Project Management Software (Gantt), MSWord, Excel, Adobe Acrobat

 

Minimum 3 years of experience in project management experience, with at least 1 year in the pharmaceutical industry.

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