Icon Plc Hiring Analytical Writers | Medical Writing

Join Icon Plc, a global leader in healthcare intelligence and clinical research, as we seek talented Analytical Writers for Medical Writing roles in Bangalore. If you have a passion for bioanalytical report writing and expertise in regulatory guidelines, this is your opportunity to shape the future of clinical development.

About Icon Plc

Icon Plc is a premier Clinical Research Organization (CRO) committed to driving innovation in healthcare. With a diverse global team, we specialize in clinical development, bioanalytical services, and regulatory compliance, helping our clients achieve groundbreaking results in clinical research.

Job Overview

H3: Role: Analytical Writer

Location: Bangalore, India
Employment Type: Hybrid (Office-Based)

Icon Plc is looking for Analytical Writers skilled in bioanalytical study reporting for clinical and preclinical research. Candidates with strong expertise in bioanalytical techniques such as ELISA and LCMS, and a solid understanding of FDA, EMA, and ICH M10 guidelines, are encouraged to apply.

Key Responsibilities

What You’ll Do:

• 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.

Desired Qualifications

Must-Have Skills:

• Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or a related field.
• 1–3 years of experience in bioanalytical report writing within clinical or preclinical environments.
• Proficiency in bioanalytical techniques such as ELISA and LCMS.
• Strong understanding of regulatory guidelines (FDA, EMA, ICH M10).
• Experience in writing reports compliant with GLP and GCP standards.

Preferred Skills:

• Expertise in bioanalytical method validation and statistical analysis.
• Familiarity with regulatory submission processes to agencies like FDA and EMA.

How to Apply

Ready to take your career to the next level? Apply now for the Analytical Writer role at Icon Plc and become part of a dynamic team dedicated to advancing clinical research.

Application Link: Apply Here

Tagged as: Good Clinical Practice (GCP), Pharmacology