Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
About the RoleJoin Thermo Fisher Scientific Inc. as a Country Approval Specialist and make a significant impact in the world of research! This is an outstanding opportunity to be part of a global leader in scientific services, where your contributions will help craft the future of healthcare and technology. Based in India, you will collaborate with world-class professionals to ensure the successful implementation of research projects while adhering to stringent approval standards.
Key ResponsibilitiesAs a Country Approval Specialist, you will:
- Coordinate and manage the country-specific approval processes for global clinical trials in India. Submit to India regulatory authority, ethics committees and coordinate, collaborate with investigator sites.
- Ensure compliance with local, national, and international regulations and optimal study startup processes.
- Collaborate with CRAs, functional leads like clinical trial manager, regulatory specialist and cross-functional teams to successfully implement projects and complete the study startup process in optimal timelines.
- Determine and strictly adhere to timelines for project approvals
- Prepare and submit required documentation for regulatory approvals for new clinical trials and ongoing clinical trials.
- Maintain flawless records of approval processes and documentation
- Obtain the essential documents, review and build the greenlight/activation packs to get approvals.
- Customise the site contracts, site budgets for clinical trials. Negotiate the legal language, study budgets with the participating sites and get the contracts executed.
To excel in this role, you must have:
- Proven experience in a study startup or clinical operations or regulatory role
- Strong understanding of Indian regulatory requirements and processes, GCP guidelines
- Outstanding organizational and communication skills.
- The ability to strictly adhere to regulatory guidelines.
- Strong analytical skills and attention to detail.
- A collaborative approach and the ability to work effectively in a team environment.
At Thermo Fisher Scientific, we are dedicated to encouraging an inclusive and collaborative environment. We appreciate diverse experiences and perspectives, which fuel our innovation and success. Our ambitious team is focused on making the world healthier, cleaner, and safer. You will have the opportunity to compete with the best in the industry and contribute to groundbreaking research.
Join us and be part of a company where your work truly matters!
Thermo Fisher Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Thermo Fisher Scientific and has not been reviewed or approved by Thermo Fisher Scientific.
-
Retirement Support — The package includes a 401(k) with a strong company match and an employee stock purchase plan, which are viewed as meaningful components of total rewards.
-
Leave & Time Off Breadth — Starting paid time off around three weeks, along with paid holidays, sick time, bereavement, volunteer time, and options to add more, is consistently highlighted as a strength.
-
Parental & Family Support — Paid parental leave for primary caregivers plus additional bonding time, together with adoption/fertility assistance and childcare benefits, provides robust family support.
Thermo Fisher Scientific Insights
Similar Jobs
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
Gallery
