Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Post : Mgr II-Research and Development
Job Description
Manage a diverse preclinical team to support global drug and device safety evaluation. Utilizes solid understanding of theories and practices of a variety of preclinical disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant toxicology expertise, design, review and/or approve complex study design concepts or toxicology assessments and provides general direction to staff.
Manage a diverse preclinical team to support global drug and device safety evaluation. Utilizes solid understanding of theories and practices of a variety of preclinical disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant toxicology expertise, design, review and/or approve complex study design concepts or toxicology assessments and provides general direction to staff.
Duties and Responsibilities:
• Select, develop and retain preclinical team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.
• Work collaboratively and effectively with other global preclinical toxicology, efficacy, and biocompatibility leads.
• Develop effective project schedules and manage project budgets for internal and external activities, as required. Employ project management tools to manage to those project schedules.
• Review and apply best-demonstrated practices, team processes, and improve operational efficiency. Seek regular input and feedback from requestors and take appropriate action. Identify and initiate discussion of key business issues affecting the project.
• Oversee development of submission content (e.g., device and container closure system; nonclinical plans, new drug registration, MOH responses development).
• Maintain current knowledge of Drug and Device guidance. Ensure compliance with study designed and familiarization with regulatory requirements and standard procedures.
• Attend Project Review and Core team meetings, as necessary.
• Select, develop and retain preclinical team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.
• Work collaboratively and effectively with other global preclinical toxicology, efficacy, and biocompatibility leads.
• Develop effective project schedules and manage project budgets for internal and external activities, as required. Employ project management tools to manage to those project schedules.
• Review and apply best-demonstrated practices, team processes, and improve operational efficiency. Seek regular input and feedback from requestors and take appropriate action. Identify and initiate discussion of key business issues affecting the project.
• Oversee development of submission content (e.g., device and container closure system; nonclinical plans, new drug registration, MOH responses development).
• Maintain current knowledge of Drug and Device guidance. Ensure compliance with study designed and familiarization with regulatory requirements and standard procedures.
• Attend Project Review and Core team meetings, as necessary.
Candidate Profile
• Knowledgeable in Toxicology or related disciplines.
• Must possess knowledge of related disciplines including pathology, clinical pathology, pharmacokinetics, and biocompatibility.
• Must demonstrate strategic leadership and proficient supervisory skills.
• Capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
• Ability to oversee and implement projects/studies outside area of expertise.
• Knowledge of US and international principle (FDA and OECD GLP) and testing guidance’s (ISO10993, Compendia, ICH, AMEA, FDA, PMDA)
• Display ability to communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management.
• Understanding of financial tools and ability to set budgets appropriately.
• Knowledgeable in Toxicology or related disciplines.
• Must possess knowledge of related disciplines including pathology, clinical pathology, pharmacokinetics, and biocompatibility.
• Must demonstrate strategic leadership and proficient supervisory skills.
• Capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
• Ability to oversee and implement projects/studies outside area of expertise.
• Knowledge of US and international principle (FDA and OECD GLP) and testing guidance’s (ISO10993, Compendia, ICH, AMEA, FDA, PMDA)
• Display ability to communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management.
• Understanding of financial tools and ability to set budgets appropriately.
Additional Information:
Experience: 10-13 years
Industry Type: Pharma
Functional Area: R&D
Job ID: 180004MD_en
Last Date: 30th June, 2018
Experience: 10-13 years
Industry Type: Pharma
Functional Area: R&D
Job ID: 180004MD_en
Last Date: 30th June, 2018
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