Project Manager, Medical Writing & Regulatory Submissions (REMOTE) - Princeton, New Jersey United States - 38862



JOB DESCRIPTION

Job #: 38862
Title: Project Manager, Medical Writing & Regulatory Submissions (REMOTE)
Job Location: Princeton, New Jersey - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 10% Bonus
Employer Will Recruit From: Nationwide
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Opportunity to join a global CRO focused on Oncology

JOB DESCRIPTION

Do you enjoy meeting the challenge of planning, communicating and controlling every stage of a project? Do you feel energized by interfacing with multiple team members from a variety of functional areas?

If you are a regulatory medical writer with at least 5 years experience within a CRO or pharmaceutical environment, we'd like to hear from you. 

Responsibilities

Project Planning and Execution:

  • Produces and manages timelines (MS Project).
  • Manages submission- related operational aspects with input from key stakeholders.
  • Effectively communicates project status, issues, and accomplishments.
  • Identifies operational risks with projects/submissions, implements mitigation plans, and manages issues to closure.
  • Leads project execution strategy plans from initiation to closeout; including definition of the project milestones, tasks, deliverables, and key dependencies 

Prepare, Review and/or Facilitate (Reporting):

  • Initial Investigational New Drug (IND) applications and amendments.
  • Non-clinical study reports.
  • Clinical study protocols and protocol amendments.
  • Investigator brochures and updates.
  • Interim and final clinical study reports.
  • IND annual reports.
  • Summary documents and other submission-related documents.
  • Development safety update reports (DSURs).
  • Special applications including Orphan Drug Designations (ODDs), Fast Track Designations (FTDs), Breakthrough Therapy Designation (BTDs), etc.
  • Finalization process of regulatory documents for submission.
  • MS Project timelines for submissions (e.g., NDAs).

QUALIFICATIONS

Qualifications

  • Bachelor’s degree required.
  • PhD/PharmD/Master’s degree in a scientific discipline, preferred.
  • 5+ years of relevant experience, required.
  • Prior experience in a CRO/pharmaceutical environment, required.   
  • Strong familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology.
  • Effective knowledge of company and sponsor-specific SOPs.
  • Ability to manage timelines and critical issues on multiple projects, simultaneously.
  • Strong ability to plan, ‘take the lead’, organize and deliver multiple and/or complex projects.
  • Team-player and highly collaborative; works effectively with other functional areas.
  • Ability to lead and motivate team members, without direct line management responsibility in a matrix environment.

Education:
University - Bachelor's Degree/3-4 Year Degree

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