Executive Biocompatibility Preclinical Studies – at MERIL, in Gujarat. Apply Now!
MERIL is hiring an Executive – Biocompatibility & Preclinical Studies in Pardi, Gujarat! If you have 2-5 years of experience in toxicology, zoology, immunology, or pharmaceuticals, this is a great opportunity to work on biocompatibility testing, animal studies, regulatory compliance, and vendor management. Join a leading medical device company and contribute to innovative R&D projects!
Job Details
- Job Type: Full-time
- Work Experience: 4-5 years
- Industry: Medical Device
- City: Pardi
- State/Province: Gujarat
- Country: India
- Zip/Postal Code: 396191
Job Description for Executive Biocompatibility Preclinical Studies:
- Coordinate and Oversee Biocompatibility & Animal Studies: Manage biocompatibility testing and animal studies for new R&D products.
- Liaison between Labs and R&D: Serve as the main communication link between labs and the R&D team to conduct biocompatibility and animal studies.
- Strategy Development: Develop and execute strategies for biological assessments of both new and existing products for regulatory submissions.
- Vendor Management: Handle vendor selection for biocompatibility, animal studies, and bioanalytical labs, including negotiations and scope definition.
- Review Compliance Documents: Review study plans, reports, and amendments to ensure adherence to regulatory requirements.
- Biological Evaluation Plans: Prepare and review biological evaluation plans and reports in line with regulatory guidelines.
- Data Compilation for Regulatory Submissions: Compile data from non-clinical studies for submissions to regulatory bodies (DCGI, CE, and USFDA).
- Non-Clinical Study Justifications: Prepare justifications and rationales for non-clinical studies of R&D products.
- Regulatory Query Compliance: Address queries raised by regulatory bodies.
- Cost Negotiation: Negotiate lab costs to ensure cost-effectiveness and justifications for study prices.
- PR Process for Non-Clinical Studies: Initiate the PR process for non-clinical studies.
- Budget Management: Manage budgeting and obtain study approval.
- Identify New Labs: Find new certified labs for non-clinical studies to ensure cost-effectiveness, quality, and timely completion.
- Team Development: Develop and train the team to execute non-clinical studies for new R&D products.
- Preclinical Research Articles: Prepare research articles detailing preclinical studies utilizing animal models.
Responsibilities for Executive Biocompatibility Preclinical Studies:
- Liaison between Labs and R&D: Serve as the main communication link between labs and the R&D team.
- Strategy Development: Develop and execute strategies for biological assessments of products.
- Vendor Management: Handle vendor selection, negotiations, and scope definition.
- Review Compliance Documents: Ensure adherence to regulatory requirements.
- Data Compilation for Regulatory Submissions: Compile data for submissions.
- Team Development: Train the team to execute non-clinical studies.
Requirements for Executive Biocompatibility Preclinical Studies:
- Experience: 2-5 yrs. of experience of toxicology, zoology, immunology or pharmaceutical industry
- Education: M.Sc. Toxicology, MSc. Biotechnology, MSc. Zoology, B.Pharma, M.Pharm or related field.
- Skills: Strong reading, writing and communication skills.
- Knowledge: Familiarity with regulatory requirements and guidelines (e.g., ICH, FDA, EMA). Experience with clinical trial protocols and data.
- Software Proficiency: Competency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with reference management tools (e.g., Pub Med, Elsevier) and document management systems.
- Communication: Excellent verbal and written communication skills. Ability to work effectively in a team and independently.
- Organization: Strong organizational and time-management skills with the ability to handle multiple priorities and meet deadlines.
Benefits for Executive Biocompatibility Preclinical Studies:
- Increased Innovation
- Stronger Team Collaboration
- Clearer Career Pathways
- Improved Decision-Making
- Enhanced Flexibility
- Fostering a Sense of Purpose
- Greater Autonomy
- Improved Employee Retention
- Effective Conflict Resolution
- Better Risk Management
- Higher Quality of Work
- Support for Continuous Improvement
- Encouragement of Leadership Development
- Strengthened Organizational Culture
- Improved Resource Allocation
Keywords: medical device, biocompatibility, animal studies, regulatory requirements,Job toxicology, zoology, communication skills, Microsoft Office Suite