Report Writer
2 weeks ago
**Job Summary**:
The **Report Writer** is responsible for preparing high-quality scientific and technical reports, including clinical study reports (CSRs), bioanalytical reports, and regulatory submission documents. This role ensures that all reports comply with regulatory guidelines, industry standards, and internal SOPs while effectively communicating scientific findings.
**Key Responsibilities**:
- Prepare and review scientific and technical reports, including clinical study reports, bioanalytical reports, and method validation reports.
- Ensure clarity, accuracy, and compliance of reports with regulatory requirements (FDA, EMA, ICH, etc.) and Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards.
- Work closely with scientists, analysts, statisticians, and quality assurance teams to interpret data and ensure accurate presentation of study results.
- Format reports as per client specifications and regulatory submission requirements.
- Maintain version control and track report progress to ensure timely completion of deliverables.
- Perform quality control (QC) checks on reports to identify inconsistencies, errors, or deviations from standard practices.
- Assist in the preparation of summaries, manuscripts, and other scientific documents for publication or regulatory submission.
- Stay updated with regulatory guidelines, industry best practices, and emerging trends in medical and regulatory writing.
**Qualifications & Experience**:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Biochemistry, or a related field.
- 2-6 years of experience in medical writing, regulatory writing, or scientific writing within a Contract Research Organization (CRO), pharmaceutical, or biotech industry.
- Strong knowledge of GLP, GCP, and ICH guidelines related to clinical and bioanalytical reporting.
- Excellent writing, editing, and proofreading skills with high attention to detail.
- Ability to interpret scientific data and present it clearly and concisely.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems.
- Strong organizational and time management skills to handle multiple projects and meet tight deadlines.
**Preferred Skills**:
- Experience with regulatory submissions, clinical protocols, and investigator brochures.
- Familiarity with statistical concepts and data analysis tools.
- Knowledge of electronic submission processes and regulatory writing software.
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