Job Description

Analytical Writer - India, Bangalore - Hybrid, Office-BasedICON plc is a world-leading healthcare intelligence and clinical research organization. Wexe2x80x99re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are looking for a highly skilled and experienced Bioanalytical Report Writer to join our team. The ideal candidate will have a background in clinical and preclinical studies, having worked in Clinical Research Organizations (CROs), and a solid understanding of bioanalytical techniques and regulatory guidelines. This role involves writing bioanalytical study reports based on data obtained from bioanalytical methods such as Sandwich and Bridging ELISA and LCMS. The candidate will also need expertise in FDA, EMA, and ICH M10 guidelines, particularly in relation to bioanalytical studies.What You Will Be Doing:

• Write and compile bioanalytical study reports for clinical and preclinical research projects, ensuring clarity, accuracy, and compliance with regulatory standards.
• Interpret and analyze bioanalytical data from studies using methods such as Sandwich and Bridging ELISA and LCMS (Liquid Chromatography-Mass Spectrometry).
• Ensure bioanalytical reports are compliant with regulatory requirements including FDA, EMA, and ICH M10 guidelines, focusing on the quality, integrity, and consistency of the data.
• Collaborate closely with clinical, preclinical, and laboratory teams to obtain the necessary data for report writing.
• Provide feedback on bioanalytical data interpretation, making recommendations as necessary.
• Ensure that reports are written in accordance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other relevant guidelines.
• Review and edit reports for scientific accuracy, consistency, and regulatory compliance.
• Work with project managers to meet deadlines and deliver reports within the specified timelines.
• Prepare study-related documentation, including study protocols, raw data reports, and study final reports.
• Participate in discussions with internal and external stakeholders regarding study design, data collection, and data analysis.

Your Profile:

• Bachelorxe2x80x99s or masterxe2x80x99s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
• Minimum of 1-3 years of experience in bioanalytical report writing, particularly in clinical and preclinical settings.
• Experience working in a Clinical Research Organization (CRO) or similar laboratories.
• Strong knowledge of bioanalytical methods such as Sandwich and Bridging ELISA and LCMS.
• In-depth understanding of regulatory guidelines, including FDA, EMA, and ICH M10 for bioanalytical studies.
• Experience in writing and reviewing bioanalytical study reports in accordance with GLP, GCP, and other regulatory standards.
• Familiarity with clinical trial processes, pharmacokinetics, Pharmacodynamics , Immunogenicity and bioanalytical data analysis.
• Strong attention to detail and ability to interpret complex data and translate it into clear, concise reports.
• Excellent written and verbal communication skills.
• Ability to work independently, prioritize tasks, and manage time effectively in a fast-paced environment.

Preferred Skills:

• Experience with bioanalytical method validation and the interpretation of validation data.
• Knowledge of statistical analysis as applied to bioanalytical data.
• Familiarity with regulatory submission processes for bioanalytical reports.
• Experience in writing reports for regulatory filings and submission to agencies like the FDA and EMA.

What ICON can offer you:Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA range of health insurance offerings to suit you and your familyxe2x80x99s needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familyxe2x80x99s well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our to read more about the benefits ICON offers.At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work wexe2x80x99ve done to become a more inclusive organisation. Wexe2x80x99re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.Are you a current ICON Employee? Please click to apply

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