Clinical Narrative Writer (Oncology)
Celgene: A major global biopharmaceutical corporation focused on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions
Celgene is looking for a Medical Writer to 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.
*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
** Celgene will not consider candidates who have been submitted to Job Posting: 6019**
Position: Clinical Narrative Writer (Oncology)
Location: Summit, NJ
Duration: 6 months with extendable opportunities.
*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
*Experience interfacing with multiple teams, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings
*Sound organizational skills
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.
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