- Location
- Bengaluru, India
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Senior
- Experience
- 2+ years
- Education
- PhD
- Source
- Keka
Description
About the job
Job Title: Medical Writer/Senior Medical Writer
Company: MS Clinical Research Pvt Ltd
Location: Indiranagar, Bangalore
Job Type: Full-time
Experience: 2-10 years
About MS Clinical:
MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing comprehensive medical writing services to pharmaceutical, biotechnology, and healthcare organizations worldwide.
Job Description:
We are seeking an experienced Medical Writer to join our vibrant team. 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:
- Bachelor's degree in life sciences, pharmacy, or related field; advanced degree (e.g., MD, PhD, PharmD) preferred.
- Minimum of 2 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.
- Proficiency in Microsoft Office Suite and familiarity with document management systems (e.g., SharePoint).
Benefits:
MS Clinical offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development and advancement.
Skills
Clinical TrialsFDA