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
Location: Ulsoor, Bengaluru
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.
Application Requirements
Please submit:
- An updated CV describing relevant report and manuscript writing experience.
- A list of representative clinical reports and publications, specifying your contribution.
- Two anonymised writing samples: one clinical study report extract and one manuscript or publication extract. Share only material you are authorised to disclose.
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.
