Senior Medical Writer – Clinical Study Reports & Scientific Publications

MS Clinical Research; Karnataka; On-site; INR 900,000 - 1,500,000; Full time

Job summary

MS Clinical Research in India, Karnataka, is seeking a Senior Medical Writer to independently develop clinical study reports, manuscripts, and related research documents for regulatory submissions. The role demands an in-depth understanding of clinical research, statistics, and clear English writing, with responsibilities spanning study report writing, manuscript development, and production of scientifically balanced discussions.

On-site, full-time position.

Qualifications

• Over 5 years of hands-on medical writing experience including CTSRs and manuscripts.
• Postgraduate qualification in Life Sciences or related field.
• Ability to interpret study results and produce balanced discussions.
• Excellent command of written and spoken English.
• Proficiency with MS Word, EndNote, and manuscript formatting guidelines.

Responsibilities

• Prepare, review, and finalise clinical study reports using protocols and statistical outputs.
• Interpret tables and figures and translate findings into scientific narratives.
• Prepare original manuscripts, abstracts, and posters.
• Apply clinical reporting guidance and maintain document versions with traceability.
• Collaborate with investigators, biostatistics, data management, and sponsors to address review comments.

Skills

Medical writing

Clinical study reports

Manuscripts

Professional English

Attention to detail

Education

Postgraduate qualification in Life Sciences / Pharmacy / Clinical Research

Tools

MS Word

EndNote/Zotero/Mendeley

Excel

PowerPoint

SAS/SPSS/R

Job description

Senior Medical Writer – Clinical Study Reports & Scientific Publications

5-10

Head Office

Full-Time

JOB DESCRIPTION

Position: Senior Medical Writer – Clinical Study Reports & Scientific Publications

Department: Medical Writing / Clinical Research

Experience: More than 5 years of relevant, hands‑on medical/scientific writing experience

Work arrangement: On‑site

Role Overview

We are seeking an experienced medical writer who can independently develop scientifically accurate clinical study reports, manuscripts, and related research documents.

The candidate must have a strong understanding of clinical research and statistics, with the ability to interpret study findings and develop clear, balanced, evidence-based discussions and conclusions. Excellent written and spoken English is mandatory.

Key Responsibilities

1. Clinical Study Report Writing

• Independently prepare, review, and finalise clinical study reports using study protocols, amendments, statistical analysis plans, and approved statistical outputs.
• Develop clear methodology, results, discussion, and conclusion sections, including appropriate presentation of efficacy and safety findings.
• Ensure consistency between the protocol, statistical outputs, report text, tables, figures, and appendices.
• Identify missing information, discrepancies, and unsupported statements, and resolve queries with the relevant study teams.

2. Statistical Interpretation and Scientific Inference

• Interpret tables, listings, and figures and translate statistical findings into accurate scientific narratives.
• Understand descriptive statistics, confidence intervals, p-values, effect sizes, and commonly used parametric and non‑parametric tests.
• Distinguish statistical significance from clinical or practical relevance.
• Correctly interpret changes from baseline, comparisons between treatment groups, and treated‑versus‑control findings according to the study design and analysis plan.
• Recognise limitations involving sample size, missing data, variability, multiple comparisons, and exploratory analyses.
• Develop conclusions supported by the study design and available evidence, including balanced reporting of non‑significant or unfavourable findings.
• Work with biostatisticians to clarify analytical questions and resolve interpretation issues before finalising documents.

3. Manuscripts and Scientific Publications

• Prepare original research manuscripts, abstracts, posters, and scientific presentations.
• Conduct focused literature searches, critically evaluate relevant publications, and maintain accurate references.
• Develop discussions that place study findings in context and explain their strengths, limitations, and implications.
• Format manuscripts according to journal requirements and support submission, revision, and responses to reviewer comments.

4. Quality, Standards, and Document Management

• Apply relevant clinical reporting guidance, publication standards, sponsor requirements, and internal SOPs.
• Check scientific accuracy, numerical consistency, grammar, referencing, formatting, and completeness.
• Maintain document versions, review histories, and traceability to supporting sources.
• Protect confidential information and uphold publication ethics.
• Manage multiple assignments and deliver agreed milestones within timelines.

5. Communication and Collaboration

• Work closely with investigators, biostatistics, data management, clinical operations, quality assurance, and sponsors.
• Confidently discuss study findings, explain scientific interpretations, and address review comments in spoken and written English.
• Coordinate document reviews and incorporate feedback while maintaining scientific accuracy.

Mandatory Qualifications and Experience

• Postgraduate qualification in Life Sciences, Pharmacy, Clinical Research, Medicine, Dentistry, Biostatistics, or a related discipline.
• More than 5 years of demonstrable experience in medical/scientific writing, including hands‑on preparation of clinical study reports and research manuscripts.
• Proven ability to independently take documents from initial draft through review and finalisation.
• Strong understanding of clinical study designs, endpoints, analysis populations, and interpretation of efficacy and safety results.
• Excellent command of written and spoken English, including scientific writing, editing, and professional discussions.
• Strong attention to detail, critical thinking, and the ability to identify inconsistencies in data and documents.
• Proficiency in Microsoft Word, including styles, automated contents, cross‑references, and tracked changes; working proficiency in Excel and PowerPoint.
• Familiarity with reference management tools such as EndNote, Zotero, or Mendeley.

Preferred Experience

• Experience in a CRO, pharmaceutical, biotechnology, or clinical research organisation.
• Experience in dermatology, cosmetic/product efficacy, instrumental assessments, or related clinical studies.
• Familiarity with ICH E3, ICH‑GCP, ICMJE recommendations, Good Publication Practice, and relevant study reporting guidelines.
• Experience supporting journal submissions and responding to peer‑review comments.
• Experience reviewing other writers’ work or mentoring junior writers.
• Familiarity with statistical software outputs from SAS, SPSS, R, or equivalent platforms.

Selection Process

Shortlisted candidates will complete a practical assessment covering:

• Interpretation of supplied statistical tables and preparation of a results narrative.
• Development of a short discussion and evidence‑based conclusion.
• Identification of numerical inconsistencies and unsupported claims.
• Written English, editing, and spoken communication.