ICON plc is a global leader in healthcare intelligence and clinical research, offering innovative solutions to shape the future of clinical development. With a diverse and inclusive work culture, ICON encourages excellence, collaboration, and innovation. If you’re a talented bioanalytical report writer with expertise in clinical and preclinical studies, this role offers a unique opportunity to make a meaningful impact
Responsibilities of an Analytical Writer
As an Analytical Writer at ICON, you’ll play a vital role in ensuring the quality and compliance of bioanalytical study reports. Your key responsibilities will include:
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- Report Compilation: Writing and compiling bioanalytical study reports for clinical and preclinical projects with precision and clarity.
- Data Analysis: Interpreting bioanalytical data from techniques like Sandwich and Bridging ELISA and LCMS (Liquid Chromatography-Mass Spectrometry).
- Regulatory Compliance: Ensuring adherence to FDA, EMA, and ICH M10 guidelines, focusing on data quality and consistency.
- Collaboration: Working closely with clinical, preclinical, and laboratory teams to gather required data.
- Feedback and Review: Providing recommendations based on data interpretation and reviewing reports for scientific accuracy.
- Documentation: Preparing study-related materials such as protocols, raw data, and final reports.
- Stakeholder Interaction: Engaging in discussions about study design, data collection, and analysis.
Qualifications and Skills Required
Essential Qualifications:
- Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
- 1-3 years of experience in bioanalytical report writing within clinical or preclinical settings.
Key Skills:
- Expertise in bioanalytical techniques like Sandwich and Bridging ELISA and LCMS.
- Knowledge of regulatory guidelines, including FDA, EMA, and ICH M10.
- Experience with GLP and GCP standards.
- Familiarity with clinical trial processes, pharmacokinetics, pharmacodynamics, and immunogenicity.
- Strong attention to detail and analytical abilities.
- Excellent written and verbal communication skills.
Preferred Skills:
- Experience in bioanalytical method validation.
- Knowledge of statistical analysis for bioanalytical data.
- Familiarity with regulatory submissions for FDA and EMA filings.
