Contract Regulatory Medical Writer
Full Time, Princeton, NJ
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 email@example.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.