Medical Writer

San Francisco  ‐ Onsite
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Keywords

Description

Responsibilities
  • Works under moderate guidance to write, proofread, and edit a variety of study- and product-related documents to support clinical research studies.
  • Under general guidance, performs daily activities related to the functional area documentation needs and requirements, according to approved procedures, templates and standards, such as routing, tracking of document status, approval notification, version control, format conversion, history record maintenance, distribution, and archiving.
  • Maintains document templates, project tracking logs, and dabases through standard electronic formats.
  • Interacts and coordinates with personnel from other functional areas such as Biostatistics, Data Management, Regulatory Affairs, Scientific Affairs, and Medical Affairs to ensure completeness and accuracy of documentation.
  • Works closely with project Biostatisticians to develop clinical protocols and study reports.
  • Works under moderate guidance to write and edit SOPs.
  • Handles documentation requests and routes other questions to appropriate staff. Tracks status of requests.
  • Leads internal/external teams and builds professional relationships.
  • Participates on clinical project teams as medical writing representative.
  • Assists with creating document templates in order to standardize documents (or sections of documents) across the department.
  • Assists Medical Affairs with development of abstracts, posters, and manuscripts.
  • Uses discretion and independent judgment within broadly defined practices and policies in selecting methods, techniques, and answers to problems lacking clearly defined solutions.


Requirements
  • Bachelor's degree in life sciences or English required
  • 3+ years of job related experience in a pharmaceutical or clinical research organization writing environment
  • Knowledge of relevant clinical research regulations and guidelines and an understanding of practical application


To find out more about Real please visit www.realstaffing.com
Start date
01/2014
From
Real Staffing
Published at
11.01.2014
Project ID:
649275
Contract type
Freelance
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