Medical Writer

San Rafael, California | Contract

Post Date: 11/04/2016 Job ID: 2176 Industry: Medical Affairs, Quality and Regulatory Affairs, Regulatory Affairs
Duties:
The Medical Writer applies advanced documentation preparation and document project management skills to lead the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

 

RESPONSIBILITIES
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’ s brochures and periodic safety reports (PSURs, DSURs, etc.)
  • May provide peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
  • Works effectively with cross-functional groups
  • Other tasks as assigned.

 
       
Skills:

Required Skills:

  • Up to 6 years of as a medical writer in the pharmaceutical industry
  • At least 10 years of medical or scientific writing experience as a primary job responsibility
  • Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
  • Familiar with clinical study data collection and results reporting.
  • Experience writing, reviewing, or editing protocols and clinical study reports required.
  • Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
  • Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
  • Ability to interpret basic tabular and graphical clinical data presentations.
  • Ability to create basic tables using AMA style (eg, Schedule of Events).
  • Intermediate applied knowledge of basic clinical laboratory tests.
  • Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
  • Basic understanding of biostatistical and clinical research concepts.
  • Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
  • Basic knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Desired Skills:

  • Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.

 

Education:
  • Bachelor’s or higher degree preferred; scientific focus desirable. 
  • Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
  • Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

 

 

OTHER INFORMATION

Strong preference for this individual to be onsite. Remote candidates will be considered but must be willing to travel to the office as needed. 

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