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Global Head of Medical Writing Operations

Company: Human Capital Resource, LLC.
Location: Whippany
Posted on: November 11, 2019

Job Description:

GLOBAL HEAD MEDICAL WRITING OPERATIONSDirect the management oversight and development of Medical Writing Specialists, Redaction as well as System Development Experts, Process Analyst Lead and Support functions supporting all clinical development projects across all therapeutic areas. This includes support of projects sponsored by both R&D as well as the Oncology, Medical Affairs, and strategic outsourced studies;Responsible for ensuring that effective and simplified medical writing processes and standards are implemented in order to achieve high quality deliverables;Responsible for driving automation and standardization not only within Medical Writing but also in cross functional projects involving interacting functions;Responsible for developing and maintaining qualified in-house Medical Writing Specialists, Redaction Experts, Experts in System Development, Process Analyst Leads and Support as well as MW inspection and audit support globally;Responsible for developing and maintaining the budget of Medical Writing Operations to support Medical Writing globally;Work with the Medical Writing Sourcing Manager to implement global outsourcing strategy;Evaluate and consider new innovations and technologies to ensure the global competitiveness of Medical Writing together with the Head of the newly formed group "System development and Automation" within MW Operations, in particular taking CDO Medical Writing business needs into account;Due to the cross-functional and collaborative nature of Medical Writing processes, these considerations impact major development processes in associated functions including R&D, SBU Oncology, Clinical Operations, Global Medical Affairs and Pharmacovigilence, and Global Regulatory Affairs.We seek candidates who possess the following:At least a Master degree and 8 years experience in the Pharmaceutical industry, or an advanced degree and at least 10 years of Pharmaceutical industry experience, of which 6 years should be related to medical writing, submission management or clinical operations;Advanced level of knowledge of all relevant industry guidance and standards (eg. FDA, EMA, ICH, HL7) as they relate to the creation, exchange and lifecycle management of healthcare information in any medical document format;Significant experience (5+ years) working in a cross-functional global environment is required;Possess proficiency in most of the following: business process modeling, document publishing, document redaction and clinical transparency, inspection and audit Documentum, Adobe Acrobat, project management, collaboration technology, validation, electronic signature technology, etc;Knowledge about new IT tools and platforms and interest in expanding technical skills;The incumbent must effectively plan, manage and utilize the resources, which include personnel, budget and equipment;Deep understanding in the management of outsourced study activities and in the management of collaborations with CROs and service providers;Six Sigma certification (green belt level) would be a plus.

Keywords: Human Capital Resource, LLC., New York , Global Head of Medical Writing Operations, Advertising , Whippany, New York

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