Syner-G is hiring for the position of Consultant I, Medical Writing in Bengaluru, Karnataka, India. The role involves preparing regulatory documents, managing medical writing projects, coordinating with clients, and ensuring compliance with applicable regulatory standards. Candidates with a background in life sciences or health sciences and at least 3 years of industry experience can apply.
The position offers remote work eligibility based on company requirements, with no minimum in-office requirement.
Job Details
| Particulars | Details |
|---|---|
| Company | Syner-G |
| Job Title | Consultant I, Medical Writing |
| Department | Medical Writing Services (MWS) |
| Location | Bengaluru, Karnataka, India |
| Work Mode | Remote work eligible, based on company requirements |
| Experience | 3+ years of industry experience |
| Education | Advanced degree in life or health sciences preferred |
| Certification | Regulatory Affairs Certification (RAC) beneficial |
Position Overview
The Consultant I, Medical Writing role focuses on authoring and managing regulatory documents, supporting regulatory strategies, and coordinating project delivery. The selected candidate will contribute to clinical and regulatory documentation, maintain submission readiness, manage project timelines, and collaborate with cross-functional teams and clients.
Key Responsibilities
- Author regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials.
- Lead the development of complex regulatory documents, including Module 2 summaries, briefing documents, and Orphan Drug, Fast-Track, and Breakthrough Designation applications.
- Perform quality control and submission-readiness checks to ensure accurate, high-quality deliverables.
- Manage project timelines, schedules, and deadlines while addressing changing client requirements.
- Coordinate client meetings, inquiries, feedback discussions, and project updates.
- Ensure consistency and accuracy across regulatory documents in accordance with applicable regulatory standards.
- Collaborate with cross-functional teams to maintain document quality.
- Contribute to regulatory strategies for early-stage and smaller clients.
- Provide guidance on document management tools, systems, and client standard operating procedures (SOPs).
- Develop medical writing expertise through exposure to new document types, processes, and industry practices.
Eligibility and Qualifications
Candidates interested in the Syner-G Consultant I, Medical Writing job should meet the following requirements:
- Experience: At least 3 years of industry experience.
- Education: An advanced degree such as M.S., PharmD, Ph.D., or M.D. in life sciences or health sciences is preferred.
- Regulatory experience: Experience with regulatory submissions and an understanding of global regulatory standards.
- Medical writing knowledge: A strong foundation in medical writing, regulatory writing, and scientific content interpretation.
- Certification: RAC certification is beneficial.
Required Skills
- Proficiency in Microsoft Word, Excel, PowerPoint, Microsoft Teams, and MS Project.
- Familiarity with regulatory document management systems such as Veeva Vault.
- Strong scientific writing and communication skills.
- Project management, time management, and prioritization skills.
- Critical thinking and data analysis skills.
- High attention to detail and accuracy during document preparation and review.
- Ability to communicate complex scientific and regulatory information clearly.
- Ability to manage multiple projects and adjust timelines proactively.
- A collaborative, patient, and empathetic approach to client interactions.
- Willingness to accept feedback and continuously improve.
Work Location and Application Details
- Location: Bengaluru, Karnataka, India
- Work arrangement: Remote work is permitted based on company requirements, with no minimum in-office requirement.
- Application: Candidates can view the official job posting and apply through the Syner-G careers portal.