Project Management

Project Manager

Contract

Medasource

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Responsibilities:

  • Coordinating functional area input and drug development deliverables
  • Provide detailed timelines for individual deliverables to the project lead
  • Ensure project team has appropriate deliverable templates 
  • Initiating escalation of issues to project lead:
    • Potential and actual timeline delays to specific deliverables
    • Out of scope work requested by the client OR functional area leads
  • Setting up project folders (currently sharepoint) for the receipt of client documentation
  • Ensuring transfer of client documents to team repository
  • Researching (scientific research, literature searches) and summarizing in a document, current literature, including current product label, treatment guidelines, competitive landscape assessments and standard of care, to assist the project lead in the preparation of all deliverables
  • Summarizing animal and clinical studies to facilitate evaluation of the potential safety and efficacy of the drug under study
  • Describing/defining data and methods used including references & citations
  • Provide detailed timelines for individual deliverables to the project lead
  • Setting up submissions related project folders within the overall project folder structure
  • Compile and coordinate publishing activities for regulatory submissions
    • Create submission document requirements lists and timeline
    • Identify internal resources (e.g, medical writers, nonclinical and CMC authors)
    • Plan workshare across submission team
    • Plan workflow and meetings with sponsor to promote submission progress
    • Collate submission documents, quality review and electronic submission
    • Serve as point of contact with health authority (Agency)
    • Coordinate team and resource for responses to questions from health authorities
  • Provide oversight and guidance to eCTD Lead
    • Liaise with Sponsors for quality review and submission
    • Liaise with publishing for submission
  • IND maintenance of regulatory submissions
    • Support sponsors for updates to regulatory submissions
    • Submit information amendments, safety reports and annual reports
    • Track and maintain correspondence and amendments with health authorities
  • Serve as US agent to FDA

Required Experience/Expertise:

  • Masters degree (or equivalent). PhD, PharmD, or MD degree is preferred.
  • Experience with medical, pharmaceutical, and/or research concepts.
  • Minimum of two years’ work experience (e.g., student internships, postdoctoral fellowships, laboratory positions, or project management).
  • Experience with principles of or project work involving Chemistry, Manufacturing, and Controls (CMC), nonclinical safety research, or clinical study design, management, or participation is desirable.
  • Working knowledge of medical terminology and basic statistical concepts is strongly preferred.
  • Proficiency in scientific writing (outlining, drafting, revising, and reviewing).
  • Excellent reasoning capabilities, scientific acumen, and writing capabilities are required.
  • Proficiency with software applications including Microsoft PowerPoint, Excel, Word, Project, Outlook, Teams, and Visio.
  • Detail-oriented, thorough, and methodical.
  • Able to reduce complex scientific data to its essence in tabular or summary form.
  • Flexible and adaptable to changes in work duties, responsibilities, and requirements.
  • Team-oriented individuals who keep others informed of the progress and status of projects.
  • Able to focus on strategic objectives in a dynamic environment.

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2205-123830

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