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Project Manager, Clinical & Regulatory

Norwood, MA

Posted: 11/07/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2198
Reporting directly to the Chief Medical Officer, the Project Manager, Clinical & Regulatory (a newly created position based on growth) will identify, track, and integrate the company’ s key drug development and regulatory timelines, identify dependencies and risks of key milestones, and assist with identifying options for achieving specified timelines. This person will be a key resource to the clinical development and regulatory groups and participate in eCTD submission planning and monitoring.
 
PRIMARY RESPONSIBILITIES: 
  • Work with all Clinical study teams to identify and track timelines for key deliverables through Clinical Study Report for each clinical trial
  • Identify and track detailed timelines for planned New Drug Application (NDA) submissions and amendments
  • Identify and track top-line timelines for other planned submissions to regulatory authorities
  • Identify dependencies among key milestones and deliverables and assist staff in identifying options to achieve milestones on time
  • Develop and track other timelines as needed by either the Chief Medical Officer or VP and Head, Regulatory Affairs
REQUIREMENTS/QUALIFICATIONS:
  • BS Degree
  • 5+ years’ experience in drug development or regulatory managing timelines/projects.
  • Experience as a Clinical Project Manager including regulatory document filing supporting CMC teams.
  • An understanding of the overall drug development process and knowledge of regulatory requirements specific to the US and EU, based on hands-on experience
  • Relevant experience in Clinical Development and/or Regulatory Affairs project management, including experience with NDA submissions
  • Ability to use verbal and written communication and negotiation and interpersonal skills to achieve understanding and accurate updates of timelines from across the company

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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