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Senior Medical Writer - Remote

Senior Medical Writer - Remote

Job Title: Senior Medical Writer - Remote
Contract Type: Permanent
Location: Virginia
Industry:
Salary: Negotiable
Reference: AM10011_1487789476
Contact Name: Amy Ma
Contact Email: a.ma@sciproglobal.com
Job Published: February 22, 2017 18:51

Job Description

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

  • 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.
  • Discuss with the relevant stakeholders the objectives, timelines, and documents to be generated; coordinate contributions from other individuals and groups.
  • Prepare and/or review SOPs and document templates.
  • Coordinate QA review of documents and maintenance of audit trails/version control.
  • Perform literature searches as necessary to obtain requisite information.
  • Prepare, or assist in the preparation of, PowerPoint presentations for scientific meetings, training webinars, and similar venues.
  • Manage and oversee the activities of medical writing vendors (i.e., individual consultant medical writers and/or CRO medical writers).

MINIMUM QUALIFICATIONS:

Education: Bachelor's degree required; advanced degree in a scientific discipline strongly preferred

Experience:

  • 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

Computer Skills: Excellent working knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook, Project), SharePoint, and have used 1 or more document management systems (Documentum/D2)

Other:

  • Evidence of the skills necessary to manage submissions.
  • 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
  • Basic understanding of electronic publishing