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Joboffer number #171970

Senior Regulatory Writer

CV Market´s client
Vilnius
Job ad expired!

Job Description

SUMMARY: The primary responsibility of the Senior Regulatory Writer is to support the Strategic Regulatory Services Department in
accordance with
global regulations and company policies. The Senior Regulatory Writer will be responsible for the preparation and finalization of routine
regulatory writing
deliverables and quality assurance/control (QA/QC) activities. The Senior Regulatory Writer may also serve as a project leader on regulatory
writing
projects and will work directly with clients. The Senior Regulatory Writer may support presales activities. The Senior Regulatory Writer
contributes to the
ongoing efforts of business development and general growth and stability of the department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Writes and/or edits regulatory documents including, but not limited to, the following CTD documents: protocols, investigator brochures,
informed
consent forms, study reports, Integrated Summary of Safety, Integrated Summary of Efficacy, Module 2 Summaries, Module 3 and Module 4
components,
and Module 1 administrative components.
  • Performs QA/QC activities per department and company policy.
  • Manages project contracts under supervision.
  • Serves as project leader on regulatory writing projects and manages project budgets.
  • Works with the Executive Director, SRS to ensure adequate project resourcing.
  • Establishes and maintains a working knowledge of global (ICH) and local (EMA) regulations and guidances.
  • Assists in the ongoing use of external consultants.
  • Documents work according to company procedures and work practices.
  • Maintains accurate records of time spent on client projects.
  • Contributes to the development and maintenance of SOPs, writing manuals, marketing materials, and internal reports.


Requirements

  • Minimum of a Bachelor’s degree in biology, chemistry, life science, English, technical writing or associated discipline from a 4-year
college or
university, or equivalent combination of education and experience. An advanced degree (MD, PhD, PharmD, or other equivalent) is strongly
preferred.
  • Sufficient experience in writing and/or editing regulatory submission documents is required.
  • Experience as a regulatory/medical writer in a pharmaceutical company and/or CRO is required.
  • Experience with authoring for electronic submissions is desirable.
  • Familiarity with AMA style or other regulatory writing styles is desirable.
  • Direct managerial experience is highly desirable.


Company offers


Darbo skelbimo numeris
#171970

Location:
Vilnius
Job type:
full-time
Additional info:
employee
Expiration date:
21 December 2012
Published:
14 December 2012

CV Market´s client

Strategic Staffing Solutions International client – one of the world’s leading consulting, systems integration and outsourcing company with presence in over 90 countries is looking for new professionals to work in Vilnius, Lithuania.

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Senior Regulatory Writer
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