Regulatory Medical Writer/Editor

South San Francisco  ‐ Onsite
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Keywords

Description

Job Purpose:

The Regulatory Submissions Editor is responsible for the preparation of high-quality submission-ready documents through effective implementation of writing and review processes. This position interfaces with multiple functional groups (e.g., clinical, drug metabolism and pharmacokinetics, nonclinical safety assessment, biometrics, research, quality), and coordinates with electronic publishing/submissions to ensure accurate, timely, and high-quality submissions that follow regulatory guidance documents (FDA, EMA, ICH). This position may support, recommend, lead, and implement process improvements.
Duties and Responsibilities:
  • Coordinates with Regulatory staff, Project Teams, and Regulatory Publishing to plan, prepare, and review submissions to regulatory agencies within agreed timelines
  • Manages document processing including assisting with preparation of clinical documents including protocols and investigator brochures
  • Manages the maintenance of regulatory submission, labeling/SPL, and cited literature reference archives
  • Develops and maintains writing tools and templates for preparation of regulatory submission documents and guides the development and maintenance of templates and tools utilized in the creation of clinical documents. Trains cross-functional teams in the use of document templates.


Qualifications:
  • Competency in medical writing, including familiarity with clinical research terminology, methods and conventions used in reporting clinical studies.
  • Experience in coordinating writing activities for regulatory submissions with regulatory publishing
  • An in-depth familiarity with pharmaceutical development and global regulatory submissions and, in particular, experience of eCTD format submissions for IND and/or NDA
  • Proficient use of MS Word, Word templates, Adobe Acrobat, and standard Office tools
  • Excellent verbal and written communication skills, strong organizational and time management skills
  • Ability to work effectively within an environment in which processes, priorities, and deadlines that may change quickly
  • College degree
  • Years of experience?
  • Minimum of 5 years applicable experience, preferably in the setting of a pharmaceutical company.


To find out more about Real please visit www.realstaffing.com
Start date
02/2014
From
Real Staffing
Published at
06.02.2014
Project ID:
661722
Contract type
Freelance
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