Alembic Pharmaceuticals, a trailblazer in the pharmaceutical industry, is inviting applications for the position of RA/RS – Clinical Affairs at their Research Centre in Vadodara. This exciting opportunity is ideal for professionals passionate about bioequivalence studies and clinical research. Women candidates are highly encouraged to apply, promoting diversity and inclusivity in the workplace.
Company Overview
Established over a century ago, Alembic Pharmaceuticals is synonymous with innovation and excellence in the pharmaceutical sector. With a global presence, the company is renowned for its commitment to quality, cutting-edge research, and a robust portfolio of products spanning various therapeutic segments.
Responsibilities in the Job
As an RA/RS in Clinical Affairs, you will:
- Conduct comprehensive literature reviews, feasibility evaluations, and design studies for bioequivalence (BE) research.
- Gain an in-depth understanding of national and international regulatory guidance for BE studies.
- Review and manage clinical study documents, focusing on studies involving healthy subjects and patient pharmacokinetics (PK).
- Perform clinical study monitoring, ensuring compliance with protocols and standards.
- Oversee the management of investigational products (IPs).
- Prepare and maintain a meticulous Trial Master File (TMF).
- Supervise the overall management of BE studies.
- Possess a basic understanding of project contracts with service providers.
- Adapt to other relevant tasks as needed to support clinical affairs.
Qualifications and Skills
Educational Background:
- A degree in Pharmacy, Life Sciences, or a related field is essential.
- Advanced degrees or certifications in clinical research or related areas will be advantageous.
Experience:
- 3–5 years of hands-on experience in clinical research, particularly in bioequivalence studies.
Technical Skills:
- Proficiency in literature analysis and clinical study design.
- Familiarity with regulatory guidance on BE studies.
- Competence in clinical study monitoring and IPs management.
- Organizational skills for maintaining a detailed Trial Master File.
Soft Skills:
- Strong communication and project management abilities.
- An eye for detail and a proactive approach to problem-solving.
