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Job Details

Clinical Narrative Writer - NJ

Company name
Apex Systems Inc

Location
Summit, NJ

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Description:

Person will support the overall Clinical Study Subject Narratives Process within Hematology/Oncology by authoring and coordinating the Clinical Study Subject Narratives for assigned studies.

This role will be a part of the Clinical Narrative Writing Group within CR&D. 

Responsibilities will include: 

Authoring of Clinical Study Subject Narratives for assigned studies

Review work of other writers (in-house or consultant) for accuracy, quality, focus, and adherence to format and stylistic requirements, review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation. 

Skills/Knowledge Required: 

Extensive experience writing all types of clinical and regulatory documents for worldwide use.

Expertise in the Oncology therapeutic areas

Experience in worldwide registration studies and large studies

Understanding and good use of all study documents: protocol, SAP, CRF, SMQs

Expertise in MS WORD, including the ability to solve technical problems with WORD templates

Excellent grammatical and communication skills, both written and oral,

Knowledge of FDA and ICH guidelines

Ability to work with multiple complex projects at a time

Ability to anticipate and resolve problems working independently

Experience working with automated data solutions in clinical documents

Experience working with CROs

Proficiency in data interpretation, sound organizational skills.

Experience interfacing with multiple teams, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings. 

Qualifications: 

BS degree in biomedical science (Masters preferred) with 10 years in the pharmaceutical industry or in a CRO, including 3 years Oncology clinical narrative writing.

For immediate consideration, please send resumes to [Click Here to Email Your Resumé]

#LI-KH2

Job Requirements

Company info

Apex Systems Inc
Website : https://www.apexlifesciences.com/

Company Profile
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.

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