Associate Director, Global Regulatory Project Management
Posted on Apr 6, 2021 by Takeda Pharmaceuticals
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associated Director, Regulatory Project Management in our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, working on the Global Regulatory Affairs team, you will be empowered to lead Regulatory teams in predicting and planning solutions to achieve operational excellence and a typical day will include:
Drive teams to achieve clarity on issues, interfacing with senior management and supporting decision-making, while monitoring timelines and developing strategies to stay on schedule and navigating through the internal Regulatory and Global Program Team governance for projects.
Partners with the Global Regulatory Lead (GRL), as well as members of other Regulatory sub-groups, to ensure that the Regulatory development strategy is translated into an efficient, executable operational plan.
Expert at project management methodologies and tools; identifies and drives strategic initiatives such as process improvements and/or departmental projects.
Leads the project planning efforts of the GRT in the definition and implementation of the Global Regulatory Strategy Plan (GRSP) as well as the operational plan and execution strategies with the team; obtains buy-in of all team members and is responsible for maintaining the GRSP. Responsible for coordinating governance approvals for key project deliverables.
Orchestrates and maintains Global Regulatory project management information needed at the GPT; manages project status reporting to Senior Management and GPTs, including scheduled and ad-hoc updates; and ensures operational plans are driven by and aligned to the global asset strategy; partners with Global Project Management (GPM) to ensure a seamless interface between Regulatory and the Global Project Team (GPT).
Identifies and recommends solutions for timeline concerns or obstacles to the GRT, including risks and issues; engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that all GRT issues arrive at a conclusion or recommendation.
Leads and manages GRTs in partnership with the GRL; drives key decisions and ensures project execution; and maintains an integrated GRT deliverable projection for functional planning, in alignment with the GRSP. Plans, manages preparation for, and attends Regulatory Health Authority interactions.
Leads project risk management processes and generates a cross-Regulatory risk register for assigned projects. Addresses and resolves project challenges, keeping leadership informed of critical considerations (eg resources, team health etc.).
Leads Global Regulatory strategic initiatives and Regulatory involvement in related external projects; acts as the project lead where required (eg Product divestments and in-licensing, large-scale manufacturing site changes, process engineering, interface with GPM Project Management Office, etc.).
Identifies and leads innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management processes and systems; and support Business Development activities.
Collaborates with the global project management operation in support of further developing project management capabilities across the organization; and develops and leads training sessions on specific technical topics related to planning tools and systems.
Partners with the Global Regulatory Lead (GRL) in presenting strategies to key stakeholders and decision makers, such as Global Program Team (GPT) members and Regulatory leadership at Project Review Meetings; and encourages collaboration and communication globally across Regulatory and between regional representatives.
Leads initiatives to develop, improve and implement RPM operational standards; and regularly informs GRA leadership of important timely issues and impact on the global program, as well as meaningful metrics for regulatory deliverables and performance.
EDUCATION, BEHAVIORAL, COMPETENCIES AND SKILLS
Bachelor's Degree in a science or business-related field is required
8+ years pharmaceutical industry experience is required, with 6+ in Regulatory. Previous drug development experience is preferred (eg Regulatory, Clinical, CMC, or other development related function).
5+ years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment is required.
Substantial experience working within Regulatory Affairs with a fluent understanding of drug development.
Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a Matrix environment.
Ability to mentor and develop skills of team members; ability to articulate and establish business processes.
Qualified project management experience; advanced expertise with project management related software and tools (ie MS Project, SharePoint etc).
Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/prepare presentations for management.
Analytical and Problem-Solving Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions.
Change Management - ability to identify, advocate and implement change positively for the organization. Demonstrates flexibility and the ability to accommodate change.
Leadership Skills - can lead and motivate team members, without direct line management responsibility. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others both inside and outside the department.
Strategic Approach - identifies, create and implement processes for Regulatory Project Management that satisfy Business Objects of Takeda globally.
Presentation skills - create and deliver presentations with appropriate messaging and focused recommendations.
Job Posting excludes CO Applicants
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 10-30% travel