Job Description

Position/Title: Technical Writer- Healthcare Regulatory
Years of Experience: 3 to 8 Years
Work Location: Bangalore, Pune and Mumbai
Notice Period: Immediate Joiners - 15 days
Employment Type: Contract
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As a Technical Writer, your responsibilities will include:
Collaborate with Stakeholders

• Understand requirements and specifications for the program.
• Develop comprehensive documentation to enhance operational efficiency and regulatory compliance.

Create Templates and Forms

• Record and track quality metrics, including bug reports, test cases, and compliance documentation.

Ensure Regulatory Compliance

• Align documentation with relevant regulatory standards such as HIPAA, GDPR, GCP, GDP, 21 CFR Part 11, etc.

Maintain Documentation Quality

• Ensure accuracy, completeness, and adherence to established standards.
• Incorporate feedback and updates from the quality assurance team.

Implement Document Control System

• Manage versioning and access control effectively.

Education:

• Postgraduate/Graduate degree in Life Science.
• Firm understanding of the Systems Development Lifecycle (SDLC).
• Previous experience as a Technical Writer or Quality Assurance Specialist in medical device software or healthcare applications.
• Strong understanding of quality management principles, including standards such as GCP and GDP.

Required Skills:

• Deep knowledge of evolving regulatory guidelines (FDA, EMA, GDPR, 21 CFR Part 11, GXP, etc.).
• Understanding of compliance frameworks and their application to data management.
• Knowledge of quality assurance principles and practices.
• Proven experience as a Business Analyst in regulatory management.
• Ability to write user-friendly, engaging content about technical subjects.
• Skill in translating technical information for a general audience.
• Familiarity with content and learning management systems (CMS and LMS).

About Client:
One of the leading providers of digital technology and consulting services to payer, providers, medical technology, and life sciences companies. With over 8,500 healthcare technology professionals worldwide, powers healthcare digital innovation, business transformation, and industry-wide convergence for over 140 organizations, through next-generation technologies, solutions, and products. Key focus areas include healthcare interoperability, secure data management, quality and performance analytics, value-based care, patient experience, medical imaging, connected health, payer-provider convergence, care coordination, and population health management.
Why should you apply?
A challenging role that will help fast-track your learning curve.
A flexible environment that allows you to work and independently.
Work in a fast-paced consulting organization.
Get an opportunity to work with the core development team and enhance your technical skills.
About CIEL HR:
CIEL HR marks the return of HR visionaries to the HR Services industry, powered by technology and analytics. The Founders of Ma Foi, the pioneer of the HR services sector in India, along with some of the finest brains in the HR Services Industry have envisioned and built the firm, CIEL HR, to deliver the full range of Recruiting services from Executive Search, Recruitment Process Outsourcing and Staffing Permanent as well as Temporary roles through its offices in India and Middle East.
Advanced data sciences and analytics have been applied by the in-house technology team to build a unique IT system for CIEL HR that helps us find the most suitable candidates in the shortest possible time.
Website:
If you think this role is aligned with your career, kindly write me an email along with your updated CV at vanshika.sharma@cielhr.com