Regulatory Medical Writer (Contract, Princeton)

Job Title:
Contract Regulatory Medical Writer

Full Time, Princeton, NJ

Job Description:
Qualified candidates will have experience in Clinical Study Reports, Protocols and Amendments, Investigator Brochures, etc… For more information, please email me your CV. I can be reached at lwalton@aerotek.com or 201-793-1006. I look forward to speaking with you soon.

I am a Recruiter for the Aerotek Clinical Research division. My company works with pharmaceutical companies on a national basis to assist them with their staffing needs both on a consulting and permanent basis in the scientific and clinical industry.

Opening is for a long term contract renewal

Pharma Company located in Princeton, NJ area and you must be commutable to the office on a daily basis.

Major Duties and Responsibilities:

  • The Contract Medical Writer (CMW) assumes responsibility in the preparation and revision of documents intended for use in clinical trials, regulatory submissions or other development and commercial activities.
  • Specifically, these responsibilities include the preparation of technical documents (e.g., pharmacology, toxicology, chemistry, manufacturing and controls) intended for regulatory submissions, as well as clinical documents:
    • Clinical study reports (CSR)
    • Clinical protocols
    • Investigational brochures
    • Integrated safety and efficacy summaries
  • Additionally, the CMW may assist in the preparation of other documents of a scientific or business nature, including, but not limited to: work orders for contract research organizations, revisions of contracts, non-confidential disclosure documents on company’s products and corporate information. The MW works closely in a crossfunctional team environment with: contract research organizations, drug development staff of company, and the drug development and/or the research institute staff.

Educational Qualifications and Relevant Prior Experience:

  • A Bachelor’s degree in the physical or life sciences is the minimum educational requirement
    • An advanced degree (masters or doctorate) incumbent will be considered, but this is not an absolute requirement.
    • American Medical Writers Association (AMWA) certification is preferred.
  • Incumbents must have a minimum of five (5) years of pharmaceutical writing experience (preferably in the employment of a pharmaceutical company or a contract research organization)
  • Major responsibility for clinical writing
    • Investigational New Drug applications,
    • New Drug Applications,
    • Clinical study protocols (CSRs)
    • Investigational brochures.
  • Proficiency, related to prior direct and relevant experience, in preparing individual preclinical and clinical documents is required.
  • Previous experience in the selection and management of contracted
    personnel (either through contract research organizations, or individual independent medical writers) is preferred.
  • Ability to work in a cross-team environment is essential.
  • Knowledge of general office programs (MS-Word, Excel, and PowerPoint) and eCTD templates is required.

Contact:
Laura Walton
lwalton@aerotek.com
(201)793-1006

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