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Senior Manager / Associate Director, Global Regulatory Project Management and Strategic Planning

Employer
Takeda
Location
Massachusetts - Virtual, Massachusetts
Start date
Jun 3, 2023

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Discipline
Administration, Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

  • Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
  • Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning.
  • Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs.

Join Takeda as a Senior Manager/Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely.

How you will contribute:

ACCOUNTABILITIES

  • Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for complex programs.
  • Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
  • Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Develop and maintain integrated regulatory project plans and integrated SWG plans.
  • Provide and oversee regulatory operational support activities for assigned programs within the TAU. Ensure out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards. Liaise and proactively engage with third party stakeholders to ensure smooth, effective and timely work flows. Operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.)
  • Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) for assigned programs. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.
  • Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones for assigned programs.
  • Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.
  • Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose solutions for addressing potential systemic bottlenecks and constraints. Conduct lessons learned sessions for assigned programs; track project variances and identify root causes; detect, raise awareness and develop plan to address systemic concerns/issues.
  • Consult, support, advise and contribute to Takeda’s body of Regulatory Project Management Knowledge and Project Management processes.
  • Provide training and support to other RPMs as required.
  • Responsible for demonstration of Takeda Leadership behaviors.

CORE ELEMENTS RELATED TO THIS ROLE

  • Excellent Leadership, interpersonal, communication, team building and negotiation skills
  • Ability to drive teams towards solutions and options
  • Ability to provide both (i) hands-on & supervisory regulatory operational support and (ii) project management leadership
  • Ability to discern between critical and the non essential

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Comprehensive understanding of the pharmaceutical industry and drug development project management and regulatory affairs (e.g., clinical development, the prescription drug distribution process, etc)

Leadership

  • Demonstrated ability to work across functions, regions and cultures
  • Functional level leadership with the ability to inspire, motivate and drive results
  • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
  • Ability to distil complex issues and ideas down to simple comprehensible terms
  • Demonstrates leadership presence and confidence
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
  • Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

  • Decision making responsibilities:
    • Provide input to highly complex decisions that impact the functional area
    • Accountable for decision making for designated function
    • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
    • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
  • Accountable for providing input to and implementing vision and strategy for designated scope

Interaction

  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
  • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
  • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

  • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
  • Comfortable challenging the status quo and bringing forward innovative solutions
  • Ability to take risks implementing innovative solutions, accelerating time to market
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
  • Role models respect and inclusion, creating a culture that fosters innovation

Complexity

  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
  • Deep expertise required
  • Ability to see and understand broader, enterprise level perspective

Minimum Requirements/Qualifications:

  • Bachelors degree required. Empahsis in Science preferred. Advanced degree preferred
  • Ideal candidate has 8 yrs related experience, preferably with 4 yrs in regulatory
  • Advanced education or credentialing in regulatory affairs and project management preferred
  • Demonstrated expert experience leading high performance teams and mentoring colleagues.
  • Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
  • At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is required.
  • Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
  • Proven ability to provide regulatory operational support and guidance.
  • Able to deal with issues of critical importance, provides regulatory operational advice and making reasoned decisions on regulatory operational issues.
  • Demonstrates leadership, problem-solving ability, flexibility and teamwork.
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Active participation in Industry groups/forums expected.
  • Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging
  • Excellent interpersonal and negotiation skills
  • Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations. Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
  • Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
  • Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
  • Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
  • Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc).

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Flexible Work Paths
  • Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

LOCATION:

  • Remote

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Base Salary Range:

Senior Manager: $130,200-$186,000

Associate Director: $143,500-$205,000

Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

#LI-Remote

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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