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