Regulatory Medical Writer

Overview

On Site
$DOE
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12+ month

Skills

pharma
Medical writer
Medical
Regulatory
AMA

Job Details

Hello,

Hope you're doing well!!
Please find the requirement below. If you find yourself comfortable with the requirement please reply back with your updated resume or call me back at

Position: Regulatory Medical Writer

Location: Hybrid (1-2 days onsite) San Rafael CA locals.

Duration: : 12+ months to start

RESPONSIBILITIES

  • Drafts and edits documents used for submissions including CTDs and RtQs
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
  • 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.)
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Works effectively with cross-functional groups within BioMarin Other tasks as assigned.

Skills:-

  • Must be a Medical writer in the pharmaceutical industry only. Other domain not accpeted.
  • Skill and Experience: At least 6+ years experience required.
  • 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. Previous protocol development experience required.
  • Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
  • Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
  • Intermediate to 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.
  • Experienced with scanners, printers, and copiers.Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Thanks,

Vinay Kumar

Senior Technical Recruiter

VISION INFOTECH INC

Phone:
Email:
368 Main Street, st #3, Melrose MA 02176

E-Verified Company

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