About the Role
Analytical Writer - Bangalore, India (Hybrid, Office-Based)
This vacancy has expired. Please explore similar opportunities below.
Company Overview
ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to creating an inclusive environment that fosters innovation and excellence. Join us in shaping the future of clinical development.
We are seeking a Bioanalytical Report Writer with expertise in clinical and preclinical studies. The ideal candidate will have experience in Clinical Research Organizations (CROs), a deep understanding of bioanalytical techniques, and a solid grasp of regulatory guidelines. This role focuses on drafting bioanalytical study reports derived from methods such as Sandwich and Bridging ELISA and LCMS, adhering to FDA, EMA, and ICH M10 guidelines.
Key Responsibilities
Author and compile bioanalytical study reports for clinical and preclinical projects, ensuring accuracy and regulatory compliance.
Analyze and interpret bioanalytical data obtained from techniques like Sandwich and Bridging ELISA and LCMS (Liquid Chromatography-Mass Spectrometry).
Ensure reports meet FDA, EMA, and ICH M10 regulatory standards, maintaining the quality and consistency of data.
Collaborate with clinical, preclinical, and laboratory teams to gather necessary data.
Provide insights and recommendations on bioanalytical data interpretation.
Adhere to GLP, GCP, and other relevant guidelines in report writing.
Review and edit reports for scientific accuracy and consistency.
Manage timelines to deliver reports as per project deadlines.
Prepare study-related documents, including protocols, raw data, and final reports.
Engage in discussions with internal and external stakeholders on study design and data analysis.
Your Profile
Education: Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
Experience: 1-3 years in bioanalytical report writing in clinical/preclinical settings, preferably in a CRO environment.
Skills:
Proficiency in Sandwich and Bridging ELISA, LCMS.
Comprehensive knowledge of FDA, EMA, and ICH M10 guidelines.
Strong understanding of GLP, GCP, and bioanalytical data analysis.
Familiarity with clinical trial processes, pharmacokinetics, pharmacodynamics, and immunogenicity.
Other Requirements:
Exceptional attention to detail and communication skills.
Ability to manage tasks independently in a dynamic environment.
Preferred Skills
Experience in bioanalytical method validation and statistical data analysis.
Knowledge of regulatory submission processes and writing for FDA/EMA filings.
What ICON Offers
At ICON, we value our people and are committed to building a diverse and high-performing culture. We offer competitive salaries and a range of benefits focused on well-being and work-life balance, including:
Annual leave entitlements.
Comprehensive health insurance plans.
Retirement planning options.
Global Employee Assistance Program.
Flexible country-specific benefits such as childcare vouchers, gym memberships, travel subsidies, and more.
For a full list of benefits, visit our careers site.
Diversity & Inclusion
ICON is dedicated to fostering an inclusive environment where diversity drives innovation. We do not tolerate discrimination or harassment in any form. All qualified applicants will receive equal consideration regardless of race, gender, disability, or veteran status.
If you require reasonable accommodations due to a medical condition or disability, please contact us to discuss your needs.
Apply Now
Interested but unsure if you meet all the qualifications? We encourage you to apply—you may be the perfect fit for this or another role at ICON.
For ICON employees: Click here to apply.
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