Report Writer

1 day ago

India VITELY CORP PVT LTD Full time

**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.

  • Content Writer

    3 days ago

    India INTO University Partnerships Full time

    We are looking for a Content Writer to join our Team in Jasola, Delhi on an initial FTC. As a key member of INTO’s Regional Marketing Team, this person will develop content across a range of INTO's channels, including blogs, social media, articles and the regional social handles. Ideally this person will have experience content writing and copywriting...

  • Medical Writer

    1 week ago

    India WovV Technologies Full time ₹ 14,40,000 - ₹ 19,20,000 per year

    Job Profile Designation-Medical Writer Experience-Fresher - Preparation of medical documentation and case reports - Quality checks of translated documents - Effective data management Job Type: Full-time Pay: ₹15, ₹20,000.00 per month Work Location: In person

  • Academic Writers

    2 weeks ago

    India Thoughtful Minds Web Services Full time

    **Academic Writers**: India Work From Home **We are hiring experienced Academic Writers to do assignment, essay, thesis, dissertation, report, online quiz, etc. for university students in the below project -** - Engineering - Civil Engineering - Accounting and Finance - IT Engineering - Mechanical Engineering - MATLAB - SPSS - Electrical Engineering -...

  • IT Proposal Writer Specialist

    2 weeks ago

    India beBeeProposal Full time ₹ 8,00,000 - ₹ 15,00,000

    IT Proposal Writer SpecialistJob Summary:We are seeking an experienced IT proposal writer to lead the sourcing, drafting, and submission of high-quality proposals for IT staffing, services, and products across various markets.Key Responsibilities:Source and identify open IT RFPs, RFIs, and RFQs relevant to IT staffing, services, and products.Draft, edit, and...

  • Medical Writer

    4 days ago

    India Syneos Health Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    JOB SUMMARY:Clinical Trial Transparency/Disclosure plays a critically important role in executing projects for Syneos global clients. He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical and technical information.Skills:We are looking for 1-4 year experience medical writer who will...

  • Principal Medical Writer

    6 days ago

    India Parexel Full time

    **Principal Medical Writer** **Minimum Qualification Requirements**: - 10+ years' experience in regulatory medical writing. Experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc. - Experience in multiple therapeutic areas, including but not limited to vaccines, immunology,...

  • Medical Writer II

    1 week ago

    India Syneos Health Full time US$ 60,000 - US$ 1,00,000 per year

    Job DescriptionExperience in QC of regulatory MW documents (protocols including amendments, CSRs, IBs and updates, etc).• Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision.•...

  • Medical Writer II

    1 week ago

    India Syneos Health Full time US$ 60,000 - US$ 1,00,000 per year

    Job Description:Main experience in CSR safety narratives writing (authoring, addressing review comments, collaborating with teams)Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision.•...

  • Breaking News Writer

    2 weeks ago

    India Iongroup Full time

    Job DescriptionAbout role:ION Analytics, part of the ION Group, is looking for a highly driven writer to join our breaking news aggregation team in Mumbai. As part of aglobal editorial organization, the successful candidate will be responsible for filing real-time news and announcements for our flagship Mergermarket and Debtwireplatforms, among others. This...

  • Content Writer

    1 week ago

    India Zesro Technologies Full time

    **Our Values**: We are proud to call our team a family. Because we believe in unity & teamwork. - We are a family. - We are on a mission to help people. - We have the courage to take risks. - We strive to reach greater heights. - We love each other. - We help each other. - We inspire each other. **Our Perks**: **Medical Insurance**: We care for you. Health...