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Intervein Research Labs, an organization driven by values and ethics, is currently seeking a skilled Bio-Analytical Report Writer (Pharma e-CTD) to join its team in Ahmedabad. This role is ideal for professionals with a strong background in pharmaceutical regulatory documentation and electronic Common Technical Document (e-CTD) submissions.
Key Responsibilities of a Bio-Analytical Report Writer
The successful candidate will play a critical role in the regulatory submission process. Primary duties include:
- Report Management: Authoring, reviewing, and finalizing bio-analytical study reports to ensure they comply with all regulatory requirements.
- e-CTD Preparation: Preparing specific documents required for e-CTD submissions.
- Regulatory Compliance: Ensuring all reports meet the stringent guidelines set by the US FDA, MHRA, and EU regulatory bodies.
- Cross-Functional Collaboration: Working closely with bio-analytical, clinical, and regulatory teams to maintain high levels of data accuracy and consistency.
- Quality Standards: Maintaining high standards in scientific writing, document formatting, and overall compliance.
Required Qualifications and Experience
Intervein Research Labs is looking for candidates who meet the following criteria:
- Educational Background: Applicants should hold an M. Pharm., B. Pharm., or M. Sc. degree.
- Professional Experience: A minimum of 3 to 5 years of experience is required.
- Industry Expertise: Proven experience specifically as a Bio-Analytical Report Writer within the pharmaceutical or Contract Research Organization (CRO) industry.
- Technical Knowledge: Hands-on experience with pharma e-CTD submissions and strong knowledge of US FDA, MHRA, and EU guidelines.
- Core Skills: Excellent scientific writing, editing, and document management skills, along with a keen attention to detail and the ability to meet strict regulatory timelines.
Preferred Skills
- Familiarity with various regulatory submission tools and document publishing workflows.
- The ability to work effectively both independently and as part of a cross-functional team.
Job Location and Compensation
- Location: Phrahlad Nagar, Ahmedabad.
- Remuneration: Competitive and based on the candidate’s individual competencies.
Intervein Research Labs offers excellent growth prospects within a congenial and professional work culture.
How to Apply
Interested candidates are encouraged to apply by sharing their professional profiles through the following channels:
- Email: hr@interveinresearchlabs.com
- WhatsApp: 9879575146 (Note: Please only send your resume; no calls are accepted)
