Regulatory Affairs Writer
Regulatory Affairs Writer
Cognizant
Job description
Are you interested in building a career in the Regulatory medical writing field? Explore this vacancy by Cognizant where you'd be doing regulatory filings, developing product submission materials and disseminating scientific knowledge in accordance with applicable industry norms and regulatory criteria.
Company Description
Cognizant is a multinational IT services company that helps businesses employ technology, engineering and industry experience to address tough challenges. The firm creates technology solutions that connect artificial intelligence investments with commercial results.
Job Summary
This hybrid post requires experience in regulatory affairs and scientific/medical writing skills to assist product submissions and research and development operations. The successful candidate will write concise, accurate and compliant regulatory documents concerning product quality, safety and efficacy.
Key Responsibilities
Prepare regulatory reports for submission to regulatory bodies detailing product safety, effectiveness, and quality information.
Translate complex scientific results and business needs into clear, succinct and compliant regulatory documents.
Apply regulatory requirements, internal processes and industry norms that are applicable to medical writing tasks.
Gather source information and check the accuracy of data and resolve any missing or inconsistent content with the appropriate parties.
Develop clinical and non-clinical summaries, risk management sections, and scientific explanations that explain the product benefit-risk profiles.
Protect sensitive information and adhere to proper documentation and data-security procedures.
Educational Qualification
A Bachelor's degree in life sciences from a recognised university.
Skills Required
Regulatory affairs and documentation expertise in life sciences.
Medical/scientific writing capabilities.
Understanding of clinical and non-clinical study documentation.
Understanding of product safety, efficacy, quality, benefit-risk information.
Excellent English communication skills including reading, writing and speaking skills.
Ability to acquire, review and validate scientific data from source documents.
Record keeping skills.
Analytical thinking and grasp of regulatory business processes.
Communicate & collaborate with cross functional stakeholders.
Salary Structure
The estimated average compensation of a Regulatory Medical Writer professional in India ranges from ₹8–10 lakhs per annum.
Career Development
This role as a Regulatory Medical Writer, will help professionals develop their skills in regulatory documentation, medical writing, compliance and product submissions. With experience, they can move into senior regulatory affairs, regulatory writing, submission management or regulatory strategy roles.
How to Apply
Go to our job portal and look for "Regulatory Affairs Writer".
Click on the link to read the full details and eligibility criteria for the position.
Fill out the required information and upload your resume.
Submit the application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.