Executive Biocompatibility Preclinical Studies
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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

APPLY ONLINE HERE 

Keywords: medical device, biocompatibility, animal studies, regulatory requirements,Job toxicology, zoology, communication skills, Microsoft Office Suite

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.