Scientific Medical Writer
BIOPHARMA SERVICES INC.
Duties and Responsibilities:
- Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent
- Perform Literature search, NDA review and scientific discussion relevant for designing a study protocol for BE and Phase 1-2a (Proof of concept)
- Review non-clinical data in preparation to transition to the First in Human clinical
- 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
- Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department
- Assist with the preparation for Regulatory agencies and participate if needed in any discussion with the
- 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
- Establish optimal timelines with external departments in order to meet study projects timelines.
- Perform other work within the Scientific Affairs department as
- Minimum University degree, M.Sc. (i.e. Pharmacy, Pharmacology or other Life Sciences relevant degree).
- At least 2 years of Scientific Protocol design and Writing experience
- Experience in an CRO environment is an asset preferably in the conduct of Phase I and Bioequivalence studies
- Excellent scientific writing
- Excellent interpersonal and communication
- Attentive to details, good initiative and able to work with changing priorities under tight timelines.
- Previous participation in Scientific discussion with Agencies (e.g. Scientific Advice meeting in EU, Pre-IND packaging and meeting with FDA) is an asset.
Job Type: Full-time
- Scientific Protocol design and Writing: 2 years (Preferred)
- Bachelor's Degree (Preferred)