Associate Director, Submission Program Management Lead

Role Overview

• Accountability for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM).
• Leading global, cross-functional submission teams to meet operational delivery goals for JJIM’s major submissions in EU and U.S. markets.
• Primary interface to JJIM’s Compound Development Team (CDT) regarding operational submission strategy.
• Key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and Project Management Leader (PML) in driving the timely delivery of major NDA/BLA/MAA submissions.
• Work across teams at all levels of the organization to ensure the highest probability of successful submission delivery while enhancing team empowerment, effectiveness, and efficiency.
• Drive development of end-to-end operational submission strategy in alignment with overall submission goals.
• Oversight of operations/delivery process, leading cross-functional submission workgroup(s) and partnering with responsible functional project managers.
• Ensure adherence to leading practices, proper risk mitigation and delivery enhancement strategies.

Requirements

• A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related field.
• 8+ years of industry/business experience is required.
• A minimum of 5 years of experience leading cross-functional teams in a matrixed work environment is required.
• 3+ years of experience in a Pharmaceutical, MedTech or comparable R&D area with demonstrated organizational awareness and applied knowledge of end-to-end (E2E) drug or medical device development is required.
• A minimum of 3 years of formal project management experience with high proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.
• Demonstrated project management leadership of cross-functional submission teams through delivery of major marketing applications in U.S. and/or EU in a matrixed setting, including working with external partners, is required.
• Proven experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines is required.
• Demonstrated strong “content awareness” and understanding of interdependencies between all major documents of eCTD is required.
• Experience leading teams through delivery of clinically focused sections of Module 2, Module 5, and Module 1 label and risk sections is required.
• Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing application in the U.S. and EU is required.
• Must have excellent verbal and written communication skills.
• Must have strong innovative and critical thinking skills.
• Must have effective cross-cultural communication skills with the ability to motivate and inspire a team to action.
• Ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.
• Ability to resolve controversy and influence teams without formal authority is required.
• Ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.

Benefits

• Inclusive work environment
• Health insurance
• Professional development