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Clinical Narrative Writer (Oncology)

New Jersey All, NJ

Posted: 11/04/2019 Job Type: Clinical Job Number: JN -112019-25922

Job Description

Responsibilities will include:

Authoring of Clinical Study Subject Narratives for assigned studies

Review of clinical data listings, as well as data from the safety database, to construct a clinical story of subjects enrolled in a study, in the form of a clinical narrative

Review work of other writers for accuracy, quality, focus, adherence to format and stylistic requirements, and the clarity, logic and order of presentation

Skills/Knowledge Required:

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

Recent Clinical Research & Development experience as a Clinical Medical Writer or Clinical Research Scientist writing clinical narratives

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

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

Proficient reviewing data listings and interpreting clinical data interpretation

Sound organizational skills

Experience interfacing with multiple teams, including clinical research scientists, clinical research physicians and statistical programmers, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings

Qualifications:

Bachelor s Degree (Advanced Degree preferred) with 3+ years Oncology Clinical Narrative Writing (not drug safety writing)

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