We are seeking an experienced Senior Medical Writer to join our vibrant team in Bangalore. The successful candidate will be responsible for creating high-quality, scientifically accurate medical documents in support of our clinical trial activities and regulatory submissions. The ideal candidate will have a strong background in medical writing, excellent communication skills, and the ability to work both independently and collaboratively in a fast-paced environment.
Responsibilities:
- Prepare and review clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and other clinical trial documents in accordance with regulatory guidelines and industry standards.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure the accuracy and completeness of medical writing deliverables.
- Interpret and summarize clinical trial data from various sources, including study reports, statistical analyses, and scientific literature.
- Assist in the preparation of regulatory submissions, including INDs, NDAs, BLAs, and MAAs, by providing high-quality medical writing support.
- Participate in project meetings, provide updates on the status of medical writing activities, and contribute to project planning and timelines.
- Stay current with developments in the field of medical writing, regulatory requirements, and therapeutic areas relevant to our projects.
- Mentor junior medical writers and provide guidance on best practices for medical writing and document preparation.
Qualifications:
- Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint).
- Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree (e.g., MD, PhD, PharmD) preferred.
- Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Proficiency in interpreting and summarizing clinical trial data, including statistical analyses and safety reports.
- Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA) governing the preparation of clinical trial documents and regulatory submissions.
- Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts clearly and effectively.
- Detail-oriented with exceptional organizational and time management skills.
- Ability to work independently and collaboratively in a multidisciplinary team environment.
Benefits:
- Competitive salary
- Health insurance
- Retirement plans
- Opportunities for professional development and advancement
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