Valeant Pharmaceuticals

  • Research Scientist, Toxicology (Nonclinical)

    Location US-NY-Rochester
    Job ID
    10628
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    • Support Surgical and Vision Care projects related primarily to product life cycle management activities and to a lesser extent to product development activities.
    • Assist in activities related to the management of relevant standards and regulations.
    • This position works with Regulatory Affairs, Formulations, Quality, Analytical Chemistry and Project Management team members providing nonclinical toxicology expertise.
    • The Research Scientist will be skilled in data analysis and interpretation.

     

    Individual contributor to product life cycle management activities and to a lesser extent to product development activities.

     

    Competencies:

    • Business impact: Toxicologist with strong emphasis on surgical products contact lens formulation, polymerization and processes. 
    • Organizes and carries out work on projects under the mentorship of a Senior Research Scientist or Principal Scientist.
    • Scope of impact: Assists with assessments of impact on biocompatibility related to product changes for multiple business units. Assists with execution of regulatory activities related to the nonclinical function.  Develops and implements processes, procedures and documents to assist streamline nonclinical safety activities.
    • Level of empowerment: Execution of tasks.  To a lesser extent, empowered to refine and improve execution
    • Scope of impact: Makes team or project recommendations

    Responsibilities

    • Evaluate available data (e.g. test reports, literature) to determine the impact of changes to the established biocompatibility of currently marketed products per ISO 10993.
    • Design and execution of nonclinical studies primarily to support Surgical and Vision Care life cycle management projects but also development projects.
    • Conduct safety assessments and evaluations of individual chemicals and final devices per the requirements of ISO 10993-1, European Union (EU) Medical Device Regulation 2017/745 and other applicable standards and regulations.
    • Act as a Subject Matter Expert (SME) for ISO and other standards related to the nonclinical group.
    • Conduct gap assessments of ISO standards comparing newly released to recently withdrawn sections.  
    • Conduct gap assessments of products evaluating the reports and documents establishing the biocompatibility of the device with the current regulatory requirements.
    • Assist Regulatory Affairs with periodic updates to Technical Files to support EU recertifications.
    • Assist with routine departmental document archiving activities and those needed to support regulatory submissions
    • Able to travel for CRO study monitoring and professional conferences
    • Key Relationship: R&D organizations (Regulatory Affairs, Formulations, Quality, Analytical Chemistry, Project Management, etc.), Procurement, Engineering, external CROs.

    Qualifications

    • Degree in Pharmacology, Toxicology, Regulatory Affairs or related discipline.
    • MS with a minimum of 2 years; BA/BS with a minimum of 3 years or a PhD. with 0 – 2 years experience in Nonclinical (i.e., toxicology) setting and/or Regulatory Affairs
    • Knowledgeable in global regulations (e.g., US FDA, EU, Japan MHLW) related to medical devices.
    • Knowledgeable in global standards (e.g., ISO 10993 series) and compendia (e.g. USP, JP,EP) related to medical devices.
    • Knowledgeable and experienced in US FDA Design Control and Change Control requirements.
    • Experience in design, implementation and data analysis of in vitro and in vivo biocompatibility/ toxicology studies to support medical device development for global registration.
    • Basic understanding of good laboratory practice (GLP) regulations.
    • Experience in conducting gap assessment of global standards.
    • Experience in writing safety assessments, researching literature and toxicology database resources, and summarizing information
    • Special Skills:  Computer Literacy with skills in Microsoft Excel, Word, Project and PowerPoint. Strong Communication, Organization, Report Writing, and Presentation skills a must. 
    • Must be able to develop working relationships with various internal core competencies, manage outside suppliers, influence others outside of their immediate control and lead team members
    • Breadth of Expertise: General assignments, project management within function, individual contributor.
    • Problem Solving: Conceives solutions and applies to solve problems of medium complexity with independence.
    • Customer focus: Experience working with internal customers and with external vendors (e.g., CROs)

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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