Scientific Medical Writer

Company: BioPharma Services Inc.

Position Title:Scientific Medical Writer 1

Salary Range: $75,000-$80,000

Job Class: Full Time

Work Location: Remote (GTA)

Duties and Responsibilities:

• Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms.
• Perform Literature search, NDA review and scientific discussion relevant to designing a study protocol for BE and Phase 1-2a (Proof of concept)
• Review non-clinical data in preparation for the transition to the First in Human clinical trial.
• Interact efficiently with PK Scientists and Biostatisticians to make sure that the study design is in line with the most updated regulatory and scientific requirements
• Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as required.
• Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department's activities.
• Assist with the preparation for Regulatory agencies and participate if needed in any discussion with the inspectors.
• Work closely with scientific, clinical personnel, and the Principal Investigator to ensure that clinical study protocol and other scientific documents are produced to the standard required by Good Clinical Practice (GCP), SOP and other applicable guidelines.
• Establish optimal timelines with external departments to meet study timelines.
• Perform other work within the Scientific Affairs department as needed.

Qualifications:

• Minimum University degree: PhD. (i.e. Pharmacy, Pharmacology or other Life Sciences relevant degree). 
• At least 3 years of Scientific Protocol design and Writing experience
• Experience in a CRO environment is an asset preferably in the conduct of Phase I and Bioequivalence studies
• Excellent scientific writing skills.
• Excellent interpersonal and communication skills.
• Attentive to details, good initiative and able to work with changing priorities under tight timelines. 
• Previous participation in Scientific discussions with Agencies (e.g. Scientific Advice meeting in EU, Pre-IND packaging and meeting with the FDA) is an asset.