Medical Regulatory Writer Consultant

Company Name:
Career Developers, Inc.
Medical Writer Consultant
12+ month contract - onsite Northern NJ
Career Developers is seeking a Medical Writer Consultant for an either 5 day on-site or a 3 day on-site opportunity . The client is seeking a candidate that will be able to devote 40 hours per week to the our client. The client expects the consultant to be working during normal working hours. The client is ideally seeking a candidate with Regulatory Medical Writing Experience.
Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
Responsibilities include prepare regulatory documents on behalf of client in accordance with the ICH guidelines, international regulations, client's standards and processes, and the clients preferred writing style guide. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports,
Brochures, and submission documents.
Participate in project team meetings to provide input regarding deliverables, timelines, and processes. Responsible for managing the document review process. Route documents for approval.
The selected medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
Qualifications: Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred.
Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite.
Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.

Experience: Five plus years of writing experience in the pharmaceutical industry. Experience in a large pharmaceutical firm is highly preferred.
Recent Oncology experience would be considered a plus.
Must have the ability and experience to independently write regulatory documents in collaboration with the various members of study team.

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