Analytical Writer

1-3 years

Not Disclosed

Bangalore

10 Dec. 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Analytical Writer
Location: Bangalore, India (Hybrid, Office-Based)
Company: ICON plc

Role Overview

ICON is seeking a highly skilled Bioanalytical Report Writer with expertise in clinical and preclinical studies. The role involves writing bioanalytical reports based on methods such as Sandwich and Bridging ELISA and LCMS. The candidate will ensure regulatory compliance (FDA, EMA, ICH M10) while delivering clear and accurate reports in alignment with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Key Responsibilities

Write and compile bioanalytical study reports, ensuring clarity, accuracy, and regulatory compliance.
Interpret and analyze bioanalytical data from Sandwich/Bridging ELISA and LCMS methods.
Ensure reports comply with FDA, EMA, and ICH M10 guidelines, ensuring data integrity and consistency.
Collaborate with clinical, preclinical, and laboratory teams to gather necessary data.
Provide feedback and recommendations on data interpretation.
Review and edit reports for scientific accuracy, consistency, and regulatory compliance.
Work with project managers to meet deadlines and deliver reports.
Prepare study-related documentation, including protocols and final reports.

Qualifications & Experience

Education: Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
Experience: 1–3 years in bioanalytical report writing, particularly in clinical and preclinical settings (CRO experience preferred).
Skills:
- Knowledge of bioanalytical methods (Sandwich/Bridging ELISA, LCMS).
- Familiarity with FDA, EMA, ICH M10 guidelines.
- Experience with GLP, GCP, and regulatory standards.
- Strong attention to detail and ability to translate complex data into clear reports.
- Excellent written and verbal communication skills.

Preferred Skills

Experience with bioanalytical method validation and interpretation.
Knowledge of statistical analysis for bioanalytical data.
Experience in writing reports for regulatory submissions (FDA, EMA).

What ICON Offers

Competitive salary and retirement planning.
Comprehensive health insurance for you and your family.
Global Employee Assistance Programme for well-being support.
Flexible benefits, including childcare, gym memberships, and travel subsidies.

At ICON, diversity, inclusion, and belonging are fundamental. We are committed to a workplace free of discrimination and harassment. Apply now, even if you don’t meet all requirements—there's a chance you’re the perfect fit for this or other roles at ICON.

Visit ICON's careers site to learn more.

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Analytical Writer

Job Description

Role Overview

Key Responsibilities

Qualifications & Experience

Preferred Skills

What ICON Offers

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