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Theradex Oncology Project Manager, Medical Writing & Regulatory Submissions (Remote) in United States

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

Newly created position - Project Manager, Medical Writing & Regulatory Submissions (Remote)

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

If you are a regulatory medical writer with at least 5 years experience 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).

Level of Education

  • Bachelor’s degree required.

  • PhD/PharmD/Master’s degree in a scientific discipline, preferred.

Prior Experience

  • 5+ years of relevant experience, required.

  • Prior experience in a CRO/pharmaceutical environment, required.

Skills and Competencies

  • Experienced in MS Word and MS Project.

  • 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.

  • Proactive, highly organized and detail oriented.

  • Strong oral and written communication skills.

  • 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.

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.

This position does not offer company provided sponsorship or relocation assistance.

Theradex is an Equal Opportunity Employer.

No agencies please.

ID: 2021-1071

External Company URL: https://www.theradex.com/