Manager/Sr. Manager, Clinical Narrative Writer Job

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Date: May 23, 2014 Location: Summit, New Jersey, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Summary/Scope: The Clinical Writer will support the overall Clinical Study Patient Narratives Process within Hematology/Oncology by authoring and coordinating the Clinical Study Patient Narratives for assigned studies. This role will report directly into the Lead Clinical Writer in Hematology/Oncology. Responsibilities: • In collaboration with other relevant line functions, lead the preparation of Clinical Study Patient Narrative Plans and Clinical Study Patient Narratives for assigned studies. • Author assigned Clinical Study Patient Narratives. • Lead team meetings with clinical and safety personnel and assist the teams in resolving issues related to Clinical Study Patient Narratives preparation for assigned studies. • Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation. • Collaboration with clinical and safety colleagues in developing the study specific narrative plan and narrative template for assigned studies. • Lead Clinical Study Patient Narratives review meetings and discussions for assigned studies. • Review work of other writers (in-house or consultant) for accuracy, quality, focus, and adherence to format and stylistic requirements. Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. *LI-LM1 Qualifications BS degree in Biomedical Science (Masters/PhD preferred) with 5+ years in the pharmaceutical industry or in a CRO, including 3+ years' Oncology clinical medical writing experience Skills/Knowledge Required: • Extensive experience writing all types of clinical & regulatory documents dossiers 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 complex projects and within cross-functional teams • Ability to anticipate and resolve problems • Experience working with automated data solutions in clinical documents • Experience working with CROs • Proficiency in data interpretation • Sound organizational skills Req ID: 14001173 Primary Location: United States-New Jersey-Summit Job: Medical Operations Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Manager Job Type: Full-time Job Level: Day Job Travel: No Job Posting: 2014-04-24 00:00:00.0
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