Senior Medical Writer-RWE
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Position: Senior Medical Writer-RWE
Location: Bangalore
Job Type: Full-time employment
Department: Medical Writing-MCAPL
Job description and responsibilities:
- Author edit and review a wide spectrum of documents including clinical protocols study reports investigator brochures (IBs) regulatory submissions manuscripts abstracts and presentation materials.
- Design and lead real-world data and epidemiological studies (protocols data collection analysis and interpretation) to assess disease trends health outcomes and risk factors; support regulatory submissions and deliver study reports publications and presentations.
- Convert detailed scientific and clinical findings into content tailored for diverse stakeholders such as regulators sponsors patients and healthcare professionals.
- Conduct comprehensive literature research to support evidence-based writing and maintain the integrity of scientific messaging.
- Work collaboratively with clinical regulatory medical marketing and technical teams to maintain scientific accuracy and message consistency across deliverables.
- Participate in cross-departmental meetings to gather insights align on expectations and support project timelines.
- Incorporate feedback from internal reviewers external stakeholders and quality review processes to refine documents.
- Oversee document version control and workflow management in accordance with project tracking tools.
- Keep abreast of therapeutic area advances evolving regulatory frameworks and best practices in medical writing.
- Provide technical mentorship manage project timelines and budgets and collaborate with cross-functional teams sponsors regulatory bodies academia and external data partners while ensuring compliance with evolving public health and regulatory standards.
- Clinical Data Management: Lead eCRF design data collection entry validation query management database testing (including UAT) and ensure timely delivery of clean reliable datasets through interim reviews and database lock.
- Quality and Compliance: Prepare DMPs/DVPs implement edit checks and reconciliation procedures coordinate with cross-functional teams and vendors and maintain compliance with GCP ICH and 21 CFR Part 11 while driving process improvements.
Qualifications:
- Masters degree in Life Sciences Epidemiology Public Health Biostatistics; Bachelors degree in Medicine Pharmacy or a related field (Ph.D. PharmD or MD preferred).
- 3-5 years of professional experience in medical/scientific writing applied epidemiology and/or public health research within CRO pharma or academic settings.
- Strong understanding of medical and scientific concepts with proven ability to translate complex information into clear concise content for diverse audiences.
- Excellent scientific writing editing and verbal communication skills with a high level of attention to detail.
- Proficiency in Microsoft Office Suite and reference management tools (e.g. EndNote Zotero).
- Knowledge about statistical software (e.g. SAS R Python) and data visualization tools is an advantage.
- Ability to manage multiple projects meet deadlines and work both independently and collaboratively across teams.
Preffered attributes:
- Experience writing in specific therapeutic areas (oncology neurology rare diseases).
- Publication record in peer-reviewed journals or experience supporting manuscripts and congress materials.
- Experience in managing clinical research would be beneficial.
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
