Sr Director / Director Medical Writing (Oncology – Hematology)

Location
94080, South San Francisco
Posted
Aug 28, 2018
Discipline
Science/R&D
Required Education
Masters Degree/MBA
Position Type
Full time

Summary:

This is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. The Director, Medical Writing is responsible for executing, managing and editing the writing of clinical, regulatory, and scientific documents for submission to regulatory agencies (US and ex-US) and for publication. This position reports to the Senior Director, Regulatory Affairs. 

Responsibilities:

  • Drive completion of medical writing deliverables covering all phases of nonclinical and clinical development for conduct of clinical trials, reporting and submission to regulatory agencies, and for scientific publication 
  • Assess and accomplish work across multiple projects/deliverables in accordance with timelines by writing and editing documents, as well as by overseeing consultant Medical Writers as necessary 
  • Establish/follow and implement SOPs, templates and style guides in accordance with industry best practice, regulatory requirements, data management and good clinical practices 
  • Ensure that documents that are high quality and meet external regulations, standards, and guidelines 
  • Work in cross-functional team/matrix environment to accomplish projects 
  • Provide training to cross-functional areas for editing, navigating, archiving etc. on software platforms and templates 
  • Perform basic publishing of regulatory documents for eCTD submissions 
  • Coordinate with Regulatory Affairs on eCTD preparation and interface with submission vendor 
  • Works with Finance to create and manage medical writing project budgets 
  • Adheres to company data Integrity, Code of Conduct and Code of Business Conduct & Ethics. 
  • Other duties as assigned 

Qualifications:

  • MS (required), PhD (preferred) Degree from an accredited institution required in Scientific or Life Sciences with a minimum of six (6) years of experience as a medical writer or a similar role preparing regulated documents in the pharmaceutical and/or biotech industry and/or CRO 
  • Must have excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively understand and present complex data 
  • Proven track record in writing and preparation of clinical/regulatory documents for US and non-US regulatory eCTD submissions required (e.g., Clinical Protocols, INDs/CTAs, NDAs/BLA/MAAs, orphan drug applications, etc.); experience with Preclinical/CMC documents and scientific publications is a plus 
  • A comprehensive understanding of the drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers for oncology/hematology oncology indications 
  • Experience managing budgets and overseeing Medical Writer consultants 
  • Demonstrated ability to negotiate, influence, and problem-solve to meet document timelines 
  • PC experience using Microsoft Word, Excel, Visio, Microsoft Project, SharePoint, PowerPoint and Adobe required 

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