Johnson & Johnson Innovative Medicine
Associate Director, Global Nonclinical Submissions Operations
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Overview
Associate Director, Global Nonclinical Submissions Operations. This position is a hybrid role and will be located in Spring House, PA. Johnson & Johnson Innovative Medicine focuses on health solutions across the full spectrum of healthcare, from discovery to life. This role leads the document specialist and SEND (Standardization for Exchange of Nonclinical Data) teams to deliver state-of-the-art submissions aligned with global requirements. Note: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you may apply to the postings, focus on the specific country(s) that align with your location(s). United States - Requisition Number: R-036415 Belgium - Requisition Number: R-038678 Johnson & Johnson is a Global Leader in Innovative Medicine and R&D recruitment for this role is described below. Responsibilities
Lead and mentor the nonclinical document specialist and SEND teams, including internal and contracted staff, to meet pipeline goals with timely and high-quality deliverables across all programs and development phases. Provide operational support for nonclinical submissions, including planning and management of timelines and resources, knowledge management of procedures and best practices, chair global submissions team meetings with agenda/minutes/action items/follow up monitoring, and generation of KPIs/metrics. Implement best practices, drive continuous improvement, and identify efficiencies to enable quickest timelines and engagement in data science initiatives to develop and adopt Artificial Intelligence (AI)/Machine Learning (ML) tools for submissions-related processes. Ensure consistent document/SEND support across portfolio and maintain adherence to standard operating procedures and regulatory requirements. Collaborate with cross-functional partners across PSTS and Discovery, Product Development and Supply (DPDS) to ensure appropriate readiness for submissions from pre-portfolio to post-registration phases. Ensure early identification and timely communication of submissions related issues and develop contingency plans proactively to address issues. Qualifications
A minimum of a Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required. An advanced degree (PharmD, Ph.D. or equivalent) is preferred. A minimum of 6 years of relevant experience with submissions supporting diverse modalities, geographies, and therapeutic areas is required. A minimum of 3 years of direct people management experience is required. Strong knowledge of nonclinical drug development and global submissions requirements is required. Strong change/process management experience is required. Knowledge of Good Laboratory Practice (GLP) and data security/integrity standards is required. Excellent communication and interpersonal skills; strong negotiating, troubleshooting and organizational skills. Ability to work effectively in a collaborative environment and coach/mentor staff. This position will require up to 10% domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
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Associate Director, Global Nonclinical Submissions Operations. This position is a hybrid role and will be located in Spring House, PA. Johnson & Johnson Innovative Medicine focuses on health solutions across the full spectrum of healthcare, from discovery to life. This role leads the document specialist and SEND (Standardization for Exchange of Nonclinical Data) teams to deliver state-of-the-art submissions aligned with global requirements. Note: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you may apply to the postings, focus on the specific country(s) that align with your location(s). United States - Requisition Number: R-036415 Belgium - Requisition Number: R-038678 Johnson & Johnson is a Global Leader in Innovative Medicine and R&D recruitment for this role is described below. Responsibilities
Lead and mentor the nonclinical document specialist and SEND teams, including internal and contracted staff, to meet pipeline goals with timely and high-quality deliverables across all programs and development phases. Provide operational support for nonclinical submissions, including planning and management of timelines and resources, knowledge management of procedures and best practices, chair global submissions team meetings with agenda/minutes/action items/follow up monitoring, and generation of KPIs/metrics. Implement best practices, drive continuous improvement, and identify efficiencies to enable quickest timelines and engagement in data science initiatives to develop and adopt Artificial Intelligence (AI)/Machine Learning (ML) tools for submissions-related processes. Ensure consistent document/SEND support across portfolio and maintain adherence to standard operating procedures and regulatory requirements. Collaborate with cross-functional partners across PSTS and Discovery, Product Development and Supply (DPDS) to ensure appropriate readiness for submissions from pre-portfolio to post-registration phases. Ensure early identification and timely communication of submissions related issues and develop contingency plans proactively to address issues. Qualifications
A minimum of a Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required. An advanced degree (PharmD, Ph.D. or equivalent) is preferred. A minimum of 6 years of relevant experience with submissions supporting diverse modalities, geographies, and therapeutic areas is required. A minimum of 3 years of direct people management experience is required. Strong knowledge of nonclinical drug development and global submissions requirements is required. Strong change/process management experience is required. Knowledge of Good Laboratory Practice (GLP) and data security/integrity standards is required. Excellent communication and interpersonal skills; strong negotiating, troubleshooting and organizational skills. Ability to work effectively in a collaborative environment and coach/mentor staff. This position will require up to 10% domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
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