Senior Medical Writer at MS Clinical Research
Location: Bangalore
Organization: MS Clinical Research
Position: Senior Medical Writer
About the Role
MS Clinical Research is on the lookout for a dedicated Senior Medical Writer to join our dynamic team in Bangalore. This role is crucial for crafting high-quality, scientifically accurate medical documents that support our clinical trials and regulatory submissions. If you are a skilled writer with a strong background in medical documentation and an ability to thrive in a collaborative, fast-paced environment, we would love to hear from you!
Key Responsibilities
As a Senior Medical Writer, your key responsibilities will include:
- Document Preparation and Review:
- Draft and review clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and other clinical trial documents.
- Ensure all documents comply with regulatory guidelines and industry standards.
- Cross-Functional Collaboration:
- Work closely with teams in clinical operations, regulatory affairs, and biostatistics.
- Ensure the accuracy and completeness of medical writing deliverables.
- Data Interpretation:
- Interpret and summarize clinical trial data from various sources, including study reports, statistical analyses, and scientific literature.
- Regulatory Submissions:
- Assist in preparing regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs).
- Provide high-quality medical writing support for these submissions.
- Project Participation:
- Attend project meetings, provide updates on medical writing activities, and contribute to project planning and timelines.
- Professional Development:
- Stay updated on developments in medical writing, regulatory requirements, and relevant therapeutic areas.
- Mentor junior medical writers and guide them on best practices in medical writing and document preparation.
Qualifications
To be considered for this role, candidates should possess:
- Education:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field. An advanced degree (e.g., MD, PhD, PharmD) is preferred.
- Experience:
- Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Skills:
- Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint).
- Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA) for preparing clinical trial documents and regulatory submissions.
- Excellent written and verbal communication skills with the ability to convey complex scientific concepts clearly.
- Detail-oriented with exceptional organizational and time management skills.
- Ability to work independently and as part of a multidisciplinary team.
Benefits
We offer a competitive package that includes:
- Competitive salary
- Health insurance
- Retirement plans
- Opportunities for professional development and career advancement
How to Apply
If you meet the qualifications and are excited about this opportunity, please submit your resume and cover letter to MS Clinical Research Careers.
For more information about medical writing and its role in clinical research, you can visit the Wikipedia page on Medical Writing.
