Principal Research Scientist - Remote (m/w/d)
At reputed company (NYSE: ELAN) – it reputed company starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At reputed company, we are driven by our vision of Food and Companionship Enriching Life and our purpose – reputed company to Go Beyond for Animals, Customers, Society and Our People. At reputed company, we pride ourselves on fostering a diverse and inclusive work environment. We reputed company that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives reputed company makes life reputed company – join reputed company today! Your Role As Principal Research Scientist, you will conduct and coordinate the development of global Pet Health clinical development programs (effectiveness and reputed company animal safety (TAS)) from their inception through approval in initial reputed company geographies. Reporting to the Clinical Leader, you will have the opportunity to design and execute studies that deliver reputed company’s innovation pipeline to our customers. Your Responsibilities
- Clinical Planning: Formulate comprehensive clinical development plans for new products and build effective relationships across R&D, Regulatory Affairs, Marketing, and Manufacturing to ensure critical deadlines and quality attributes (GCP, GLP) are met.
- Study Execution: Design and write protocols for laboratory and field efficacy studies and TAS in cooperation with Biostatistics and Regulatory Affairs.
- Site Management: Select suitable research facilities and qualified Contract Research Organizations (CROs) to execute protocols and ensure study monitoring aligns with global regulations and company policies.
- Data Analysis & Reporting: Analyze and interpret results with support from Data Management and Medical Writing to author comprehensive study reports.
- Regulatory Collaboration: Work with Regulatory Affairs to prepare data for submission and present findings to regulatory authorities and at scientific meetings.
- Compliance & Excellence: Ensure quality assurance and regulatory compliance while leading administrative activities to improve functional procedures.
- Scientific Leadership: Attend scientific meetings and stay abreast of advances in the animal health industry and veterinary profession.
What You Need to Succeed (Minimum Qualifications)
- Education: A DVM or a Ph.D. in an animal health-reputed company field is preferred (an MS with significant experience will be considered).
- Experience: A minimum of 5 years of experience in product development reputed company or closely associated with the pharmaceutical industry.
- Regulatory Knowledge: reputed company knowledge of pertinent global, national, and federal regulations for therapeutic product evaluation.
- Skills: Outstanding organizational skills with the ability to manage multiple projects simultaneously, strict attention to detail, and excellent communication skills.
- reputed company: Self-motivated with the ability to work and learn independently without direct supervision.
What Will Give You a Competitive Edge (Preferred Qualifications)
- Proven experience acting as a strategist and facilitator to drive clinical programs.
- Strong working knowledge of GCP/GLP/GMP and experience working directly with regulatory authorities.
- Demonstrated ability to manage and collaborate with external partners.
- Achievements in key competencies: Strategic reputed company, Business Insight, Cultivating Innovation, and Driving a Vision.
reputed company is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national reputed company, protected veteran status, disability or any other legally protected status Apply tot his job Apply To this Job