Apply for Senior Medical Writer II at ProPharma India. Check eligibility, experience, responsibilities, salary details and apply online for this role today.
Introduction
If you have strong experience in regulatory and clinical writing, this is a premium career opportunity. The Senior Medical Writer II at ProPharma Group role offers the chance to work on global clinical documents, regulatory submissions, and high-impact drug development projects. This position is ideal for experienced professionals seeking growth in medical writing and regulatory sciences.
Job Overview
| Job Title | Senior Medical Writer II |
|---|---|
| Company Name | ProPharma Group |
| Location | India (Remote/Hybrid) |
| Employment Type | Full-Time |
| Department | Medical Writing / Clinical & Regulatory |
| Experience Required | 6+ Years |
| Education | Bachelor’s or higher in Life Sciences |
| Salary | As per company standards |
Company Overview
ProPharma Group is a leading global consulting firm providing services across clinical research, regulatory affairs, pharmacovigilance, and quality compliance. With over 20 years of experience, ProPharma supports pharmaceutical, biotech, and medical device companies in bringing innovative therapies to market efficiently and safely.
Job Location & Employment Type
- Location: India (Remote/Hybrid model)
- Employment Type: Full-Time
- Work Mode: Flexible (Remote with optional office collaboration)
Open Positions / Department Details
This role is part of the Medical Writing team, responsible for preparing clinical, regulatory, and safety documents across all phases of drug development. The position involves working with global clients and cross-functional teams.
Key Roles & Responsibilities
Medical Writing & Documentation
- Author and edit clinical and regulatory documents such as protocols, CSRs, IBs, DSURs, and IND/NDA submissions
- Prepare complex documents including PBRER, MAA, and eCTD submissions
- Ensure high-quality, accurate, and compliant documentation
Regulatory Compliance
- Follow guidelines such as ICH E3, ICH E6 (R2), and EU MDR/IVDR
- Ensure alignment with regulatory standards and client requirements
- Maintain audit trails and documentation quality
Project & Client Management
- Manage multiple writing projects simultaneously
- Communicate directly with clients and manage expectations
- Lead project meetings and track deliverables
Collaboration & Review
- Work with cross-functional teams including clinical operations, data management, and biostatistics
- Perform peer review and quality checks of documents
- Review statistical analysis plans and data outputs
Mentorship & Development
- Train and mentor junior medical writers
- Participate in process improvement initiatives
- Contribute to team development and knowledge sharing
Eligibility Criteria
Education
- Bachelor’s degree or higher in Life Sciences or related field
Experience
- Minimum 6+ years of experience in clinical/regulatory medical writing
Skills Required
- Strong knowledge of clinical research and regulatory guidelines
- Experience with global regulatory submissions (IND, NDA, BLA, MAA)
- Excellent writing, editing, and communication skills
- Proficiency in MS Word and document formatting
- Strong project management and organizational skills
- Ability to work independently and manage multiple tasks
Salary & Benefits
- Salary: As per company standards
- Opportunity to work on global regulatory projects
- Flexible remote/hybrid work model
- Career growth in medical writing and regulatory consulting
- Exposure to diverse therapeutic areas
- Learning and development opportunities
Selection Process
The recruitment process typically includes:
- Online application submission
- Resume screening
- Writing/technical assessment
- Interview rounds (Technical + HR)
- Final selection
How to Apply
Candidates interested in the Senior Medical Writer II at ProPharma Group role can apply through the official careers portal. Ensure your resume highlights relevant regulatory writing experience and project work.
Important Dates
- Apply as soon as possible (no fixed deadline mentioned)
Why Apply for This Job?
- Work with global pharmaceutical and biotech clients
- Gain exposure to high-level regulatory submissions
- Opportunity to mentor and lead writing teams
- Flexible work environment with remote options
- Strong career growth in medical writing and consulting
- Be part of impactful drug development projects
FAQs
1. Who can apply for this job?
Candidates with 6+ years of experience in clinical or regulatory medical writing can apply.
2. Is remote work available?
Yes, this role supports remote or hybrid working.
3. What documents will I work on?
You will work on protocols, CSRs, IND/NDA submissions, and other regulatory documents.
4. What skills are important for this role?
Medical writing expertise, regulatory knowledge, and project management skills are essential.
5. How can I apply for this job?
You can apply online through the official ProPharma careers website.
Conclusion
The Senior Medical Writer II at ProPharma Group role is an excellent opportunity for experienced professionals to advance their careers in regulatory and clinical writing. With global exposure, flexible work options, and involvement in critical drug development projects, this position offers strong professional growth. Apply now to take your career to the next level.
Disclaimer
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