Project Manager, Medical Writing & Regulatory Submissions (REMOTE)
|Princeton, New Jersey - United States
contact recruiter for details
WHY IS THIS A GREAT OPPORTUNITY?
Opportunity to join a global CRO focused on Oncology
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.
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).
- 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.
University - Bachelor's Degree/3-4 Year Degree