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About the Role
BioPharma Services Inc. is seeking a Scientific Medical Writer 1 to contribute to the design and documentation of clinical studies.
Responsibilities
- Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent Forms.
- Perform literature searches, NDA reviews, and scientific discussions for study protocol design.
- Review non-clinical data for transition to First in Human clinical trials.
- Collaborate with PK Scientists and Biostatisticians to ensure study designs meet regulatory and scientific requirements.
- Liaise with Institutional Review Boards regarding protocols, informed consent forms, and other necessary documents.
- Assist in developing Standard Operating Procedures (SOPs) and guidelines for departmental activities.
- Support the preparation for Regulatory agencies and participate in discussions with inspectors.
- Ensure clinical study protocols and scientific documents meet Good Clinical Practice (GCP), SOP, and applicable guideline standards.
- Establish optimal timelines with external departments to meet study deadlines.
- Perform other tasks within the Scientific Affairs department as required.
Requirements
- Minimum University degree: PhD (Pharmacy, Pharmacology, or other relevant Life Sciences degree).
- At least 3 years of Scientific Protocol design and Writing experience.
- Experience in a CRO environment is an asset, preferably in conducting Phase I and Bioequivalence studies.
- Excellent scientific writing skills.
- Excellent interpersonal and communication skills.
- Attentive to details, demonstrates good initiative, and can 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.
Skills
- Scientific Writing
- Protocol Design
- Literature Search
- NDA Review
- Interpersonal Skills
- Communication Skills
- Attention to Detail
- Initiative
- Time Management
Location
- Remote (GTA)
Work Type
- Full Time
- Remote
Experience Level
- 3+ years
Education Level
- PhD
Salary/Compensations
- $75,000-$80,000
About the Company
- BioPharma Services Inc.