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Réviseur Bioanalytique / Bioanalytical Advisor
Syneos Health, Inc.
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Discover more opportunities than anywhere else. Find more jobs nowRéviseur Bioanalytique / Bioanalytical Advisor
Job summary
A leading biopharmaceutical solutions organization in Quebec is seeking a Bioanalytical Advisor. This role involves providing scientific guidance on bioanalytical solutions, reviewing protocols, and ensuring regulatory compliance throughout clinical and non-clinical trials. Candidates should hold a Bachelor's degree in a science-related field, possess strong English communication skills, and preferably have regulatory experience. The company offers comprehensive support and opportunities for career development along with a culture of authenticity and belonging.
Benefits
Qualifications
- Bachelor’s degree in a related field is essential.
- Postgraduate diplomas are acceptable as alternative qualifications.
- Experience in regulatory aspects is considered beneficial.
Responsibilities
- Review study protocols to ensure bioanalytical solutions alignment.
- Write and update sample collection and shipping instructions.
- Train clinical staff on sample collection procedures.
- Act as a technical advisor for investigative and regulatory queries.
- Evaluate calibration intervals based on available data.
- Guide on bioanalytical strategies to meet study goals.
- Support on regulatory bioanalysis questions during submissions.
- Ensure compliance with corporate policies and guidance.
Skills
Education
Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. The bioanalytical advisor supports clinical and non‑clinical trials by providing scientific guidance on sample collection, assay validation, and regulatory strategy.
- Review study protocols to ensure that bioanalytical solutions meet study objectives.
- Write and revise sample collection and shipping instructions to maintain sample integrity from site collection to laboratory analysis.
- Provide direct training to clinical staff on sample collection procedures when required.
- Act as a technical advisor to the bioanalysis service for investigative and regulatory questions.
- Evaluate optimal calibration intervals for bioanalytical methods based on available documentation, prior experience, or promoter data.
- Offer guidance on the most relevant bioanalytical strategies for the chemical groups to be measured to support study goals.
- Support promoters on regulatory bioanalysis questions during submission verification (letters of observation, submission support, etc.).
- Execute activities in compliance with applicable corporate and division policies, standard operating procedures, and operational guidance.
- Bachelor’s degree in science or related field.
- Relevant postgraduate diploma acceptable.
- Regulatory experience considered an asset.
- Fluency in English (verbal and written technical communication, procedure and report writing).
- Career development and progression opportunities.
- Supportive and engaged line management.
- Technical and therapeutic area training.
- Peer recognition and total rewards program.
- Total Self culture promoting authentic self‑expression and belonging.
The Company is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive, and to providing reasonable accommodations when appropriate.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.