Sr. Medical Writer

Sr. Medical Writer
Company:

Zachary Piper Solutions, Llc


Sr. Medical Writer

Details of the offer

Piper Companies
is seeking a
Sr. Medical Writer
in
Blue Bell, PA
to join a leader in the pharmaceutical industry providing support to partners in the Life Science industries.
This is a 6 month contract to hire opportunity. The medical writer will support coordination of medical writing activities for cross departmental company projects. Independently write, edit, and compile clinical/regulatory documents specifically protocol development for all phase clinical trials, clinical study reports, support NDA/IND submissions, investigator related documents as well as reports for safety and epidemiology projects such as REMS and KABS.
Responsibilities for the Sr. Medical Writer:
Preparation of departmental deliverables, such as clinical protocol development/REMS reports, regulatory clinical study reports for all phases, IND, NDA and CTD summary documents, and manuscripts for publication
Review and understand Client Report Templates and Style Guides
Collaborate with other company departments including Data Management, Programming, Biostats, Quality Assurance and Project Manager
Participate in proposal preparation and resource allocation
Knowledge of the utilization and implementation of sponsor related style guides
Ensure SOPs are clearly written and up to date with current regulations/guidelines
Qualifications for the Sr. Medical Writer:
8+ years' experience within medical writing within pharma or CRO environments
Proven history of reports for Risk Evaluation & Mitigation Strategy (REMS) and Knowledge, Attitude & Behavior (KAB) studies.
Ability to communicate across all levels
Able to work independently
Bachelor's degree in Life Sciences or related field preferred
Compensation for the Sr. Medical Writer:
Salary is commensurate to experience
Full Benefits: Medical, Dental, Vision, Rx, 401k plan


Source: Dice


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