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Regulatory Medical Writer

Regulatory Medical Writer

Job Title: Regulatory Medical Writer
Contract Type: Permanent
Location: Richmond, Virginia
Industry:
Salary: Negotiable
Reference: Murfin RegWriter_1495236014
Contact Name: Kyle Murfin
Contact Email: k.murfin@sciproglobal.com
Job Published: May 20, 2017 00:20

Job Description

Regulatory Medical Writer - Remote

The scope of this position includes the writing, coordination and oversight of clinical deliverables including clinical study protocols, protocol amendments, and clinical study reports, Investigator's Brochures, clinical contributions to briefing documents and annual safety reports as well as other IND/NDA/CTA or global regulatory submission documents.

Functions:

  • Write and/or coordinate with internal and external resources the clinical and related sections of INDs, NDAs, MAAs, CTAs , and similar documents. Resolve conflicting comments among reviewers and interact with multidisciplinary team members as appropriate.
  • Provide clinical medical writing services that include writing and editing of clinical/regulatory/ medical documents that include but are not limited to protocols, informed consents, investigator brochures, annual safety reports, and manuscripts.

Qualifications:

  • 5 years of pharmaceutical industry experience
  • 3 years of regulatory medical writing experience
  • Experience writing clinical study protocols, protocol amendments, clinical study reports, Investigator's Brochures, clinical contributions to briefing documents and annual safety reports as well as other IND/NDA/CTA /global regulatory submission documents.

If you are interested in this position, call Kyle at (415) 621-9281 or apply within.

Regulatory Medical Writer - Remote

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