Consultant I, Medical Writing

Syner G; Bengaluru; Remote; INR 1,200,000 - 1,800,000; Full time

Job summary

Syner-G seeks a MWS Consultant I to author regulatory documents, lead module development, and ensure submission readiness. You will coordinate with cross-functional teams, manage timelines, and engage with clients to deliver high-quality regulatory materials.

Ideal candidates have a life or health science degree, 3+ years in regulatory writing, and familiarity with Veeva Vault; RAC is a plus. Remote-friendly role with Indian operations.

Qualifications

• Advanced life/health science degree preferred.
• RAC certification is a plus.
• 3+ years in regulatory writing or medical writing.

Responsibilities

• Author regulatory documents such as CSR, study protocols, and submissions.
• Lead complex module development (Module 2 summaries, Briefing Documents).
• Maintain submission-readiness and ensure alignment with standards.
• Coordinate with cross-functional teams and manage timelines.
• Engage in client interactions and maintain strong relationships.

Skills

Medical writing

Regulatory writing

Time management

Cross-cultural communication

Education

M.S./Ph.D. in life or health science

RAC certification beneficial

Tools

Veeva Vault

Microsoft Office

Job description

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here .

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

T he MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards. This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross‑functional teams to meet diverse client needs across varying stages of development.The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.

WORK LOCATION:

The MWS Consultant Iposition is eligible for remote work based on company requirements, with no minimum in-office requirement .

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Author a variety of regulatory documents, includingClinical StudyReports(CSRs), study protocols, and client submissionmaterials.
• Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents,Orphan Drug, Fast-Track, and Breakthrough Designation applications).
• Apply quality control and submission-readiness processes to deliver high-quality documentswithinagreedclient timelines.
• Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clientstoaddress evolving demands.
• Planforandanticipateproject challenges, updatevisualtimelines,andmaintainadherence todeadlines.
• Facilitateclient interactions, including meetings, inquiries, and feedback discussions, whilebuilding andmaintainingclient trust.
• Ensure consistency,accuracy,and alignmentacross documents with client updates andapplicableregulatorystandards.
• Collaborate with cross-functional teams to ensure the quality and accuracy of regulatorydocuments.
• Contribute to the development of regulatory strategies for early-stage and smaller clients.
• Provide guidance on tools, document management systems, and client SOPs.
• Engage in continuous learningthroughexposure to new documenttypes, processes, and industrybest practices under senior mentorship.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
• RAC certification is beneficial.

Technical Experience:

• 3+ years industry experience
• Proficiencyin Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project.
• Familiarity with regulatory document management systems, such as Veeva Vault.
• Experience with regulatory submissions and understanding of global regulatory standards.

Knowledge, Skills, and Abilities:

• Strong foundationin medical writing, regulatory writing, and interpretation of scientific content.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials andregulatorysubmissions.
• Effective written and verbal communication skills, with theability to communicate complex scientific and regulatory information clearly and concisely.
• Exceptional project and time management skills, with the ability to prioritize multiple projects andadjust timelines proactively.
• Patient and empathetic approach, especially in cross-cultural and client-facing environments.
• Positive attitude toward feedback and a willingness toapply itfor continuous improvement.
• Strong critical thinking and data analysis skills to ensure scientific claims align with evidence andregulatoryrequirements.
• High attention to detail, ensuring alignment and accuracy across multiple document reviews.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.