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Contract NDA Submission Project Manager

Cambridge, Massachusetts

Post Date: 06/07/2017 Job ID: 1501 Job Category: Clinical: R&D Program Management

My client is currently seeking a Contract NDA Submission Project Manager to fill a role on site for up to 1 year.

Job  Responsibilities:
  • Provide support to ensure the Regulatory Lead and cross functional program team develop and seamlessly execute global regulatory strategies enabling successful marketing applications with Health Authorities.
  • Utilize robust project management methodologies to ensure the development, utilization and continuous improvement of tools and processes to meet project deliverables.
  • Ensure product specific strategies are documented, maintained, updated and proactively coordinated and endorsed by key stakeholders. Ensure transparent and constant communication of objectives and strategies across program teams, sub-teams, and senior stakeholders.
  • Encourage and model creative problem solving and demonstrate innovative approaches in working within a dynamic environment. Assist regulatory lead in problem solving and generate options to enable effective and timely decision making.
  • Develop and maintain project plan and ensure execution of regulatory filing focused on quality and schedule.
  • Prepare and coordinate meetings including scheduling agendas, minutes, action item and decision logs and timelines. Maintain real-time project documentation to ensure alignment and agreement on tasks, timing and approach.
  • Assist with the identification and elevation of potential major and critical project risks / issues as appropriate.
  • As necessary, coordinate key cross-functional tasks in order to deliver high quality deliverables on schedule.
  • Prepare and distribute reports and trackers to communicate updates and project status.
  • Communicate and drive follow-up on action items as well as provide project status updates to internal & external Partners/Vendors/CMOs/CROs.
  • Track project variances and report and prepare variance reports. Assist with the identification of root causes of variances.


Qualifications/ Requirements:
  • Experience in the submission and approvals of NDAs and MAAs in the role of project manager.
  • Thorough understanding of US & Global regulations, standards and guidance documents.
  • Experience in Project Management leading cross-functional drug development or regulatory teams - PMP Certification or equivalent highly desired.
  • BS degree in Science discipline - Chemistry, Biochemistry or equivalent with at least 3 years in a related position in industry.
  • Experience corresponding and interacting with regulatory agencies, particularly with the FDA.
  • Technical Writing Skills.
  • Ability to effectively organize, multitask, and works in a fast-paced, deadline driven work environment.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution-oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possess strong written and verbal communication skills.

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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