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Medical Writer III
Ref No.: 17-06708
Location: Pearl River, New York
Start Date / End Date: 12/04/2017 to 06/03/2019
Job Description: Job Description

Job Title: Clinical Scientist Communications Lead, Vaccines Clinical Research & Development (Contractor)

Role Description
The clinical scientist communications lead (CSCL) supports global project teams and interfacing writing groups in the development and writing of timely, high-quality vaccine clinical documents. The CSCL ensures that these documents are prepared according to Pharmaceutical and Vaccine Clinical Research & Development standards, and that messages in them are scientifically accurate, consistent, and complete. The CSCL collaborates with leads from interfacing groups to ensure that critical writing needs and timelines for all Vaccine Research global and regional regulatory submissions are communicated to stakeholders and are met.

Responsibilities
As a member of the clinical project team, collaborates with global and regional functional line representatives and partner-line and vendor medical writers on assigned projects to provide experienced, high-level support and guidance on the preparation and finalization of clinical regulatory documents.

Establishes therapeutic area (Vaccines) and program-level document processes, standards, and templates. Trains, instructs, and provides guidance on these processes and standards to writers, project team members, and partner-line colleagues.

Reviews draft clinical documents prepared by vendor and partner-line writers.

Plans and writes high-quality, scientifically accurate clinical documents (those within Vaccine Clinical Research’s remit).

Education
PhD (preferably in biological sciences) plus 8+ years or comparable experience (BS plus 12+ years, MS plus 10+ years) preferred.

Experience/Skills
A background in vaccines or infectious diseases and in clinical research is preferred.
Experience with clinical document writing and preparation for regulatory submissions and/or publication experience.
A working knowledge of statistics, data analysis, and data interpretation.
Knowledge of regulatory systems and processes in other regions is preferred.
Training/experience in clinical research, clinical writing, regulatory affairs/regulations, and computer science applications relevant to the work (e.g. MS Word and working knowledge of submission-ready document templates).
Experience with clinical document editing, data quality review, and project management preferred.
Excellent oral and written communication skills required.

Technical Skills
Analytical skills and understanding of statistics
Project and process management skills
Priority setting and problem solving

Work schedule

Work is assigned on an as-needed basis during standard work week (8 am – 5 pm, Monday – Friday). Project priorities occasionally necessitate work in the evening and over weekends.
Position Comments visible to MSP and Supplier: location can be Pearl River NY or Collegeville PA
old request number 8663-1