Junior Medical Writer

• posted by admin
• posted in Careers

Reports to: Senior Manager, Medical Writing and Research

Duties and Responsibilities:

• Write Phase 1 and Bioequivalence Study Protocols, Informed Consent Forms, and Clinical Study Reports.
• Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as required. Act as a secondary liaison between the company and the Institutional Review Board.
• Assist in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
• Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
• Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
• Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
• Compile study documents.
• Clinical data entry and Quality Control when required.
• Photocopy and scan study documents.
• Perform other work as assigned
• Archiving.

Qualifications:

• Minimum university degree, B.Sc. (i.e. Life Sciences) or at least 4 years of pharmaceutical and/or clinical experience.
• Experience in an CRO environment, preferably in the conduct of Phase I and Bioequivalence studies
• Good interpersonal and communication skills.
• Attentive to details, good initiative and able to work with changing priorities

Please send your resume to  pgardzinski@biopharmaservices.ca