Senior Project Manager, Global Medical Affairs, Immunology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Job Summary:

Leads Operational Management for the Global Medical Affairs Program (Immunology) and is a champion for cross-functional and cross-regional collaboration with seamless, efficient delivery of Global Medical Affairs (GMA) objectives on time and on budget. Develops, with Global/Regional Medical Leadership, Global Medical Affairs and Franchise Program Actions Plans from MSD, providing monthly updates and mitigations plans as needed. Develops Project Plans for Other Key Global Medical Program Activities, Projects, Programs, based on Medical Strategy, tracking status in monthly reports. Leads project management and tactical operational support for certain Global Medical Activities or Projects. The role owns oversight of Global Tactical Execution and Budget spend; tracking and transparently reporting status, changes and/or mitigation to Global Medical Leadership. The role supports internal review processes for Immunology Global Medical Projects and facilitates team execution. Role communicates regularly with global and regional finance and operations on budget and status; and manages Shepards financial processes for GMA tactics. 

Essential Functions:

Leads Operational Management for the Global Medical Affairs Product Strategic Plan

• Champion key internal processes for medical review of certain global activities, projects, or programs; and manages those processes smoothly for GMA.


• Applies program management expertise, methodologies, and standards to support the GMA Team


• Develops and executes continuous improvements; tracks objectives and key results and metrics; and implements best practices in support of process improvements.


• Facilitates and coordinates group/team meetings, ensuring results-oriented meetings and positive team dynamics. Defines and delegates responsibilities, goals, and deliverables with team members in support of GMA Team.


• Provides regular reports and communicates effectively with team members, senior leaders, and key stakeholders on assigned program's progress, issues, risks, needs, and opportunities


• Develops, maintains, tracks, and manages high quality, integrated project plan, including clearly identified critical paths and key risks as appropriate


• Partner closely with the Finance department with developing, maintaining, tracking, and managing the budget and by identifying budgetary impacts of strategic and critical issues

Champion of Key Global Medical Affairs Processes & Meetings

• Track and communicate all key timelines for deliverables (e.g. Medical Affairs plan, monthly and quarterly reports, annual budget planning process)


• Collaborate with team on the creation of contracts, purchase orders, consulting agreements, and meeting contents for medical meetings (e.g. Ad Boards) and specified projects.


• Support tracking, analysis, and reconciliation of invoices and purchase orders regarding meetings and specified projects.


• Maintain and manage Medial Affairs databases for respective TA (e.g. SharePoint / Teams)


• Develops global monthly insight reports, integrated from regional reports and in alignment with new GMA Processes.


• Collaborate with team to develop and champion appropriate governance, charters, and global meeting cadence


• Organize, coordinate, and execute Global Meetings (logistics, financial administration, medical reviews as required and documentation)


• Project manage relevant Medical Affairs team meetings and work streams, quarterly review meetings, and governance associated follow-up on actions and reporting.


• Maintain Project tracking and documentation e.g. functional activity status, critical activities, remediation plans, status updates for the Global Leadership

Job Requirements:

Education

Bachelor’s degree with scientific focus. Advance scientific or business degree preferred. Project Management qualification (PMP or equivalent) required.

Experience

• Minimum five (5) years project management experience within the biotech/pharmaceutical industry working with cross-functional project teams in a global business environment.


• Broad understanding of pharmaceutical development, Medical Affairs, and commercialization concerning cross-functional responsibilities including but not limited to Clinical Development, Medical Affairs, Tech Ops, Quality, Safety, Regulatory and Commercial. In-depth knowledge with pharmaceutical regulatory, legal requirements and global execution.


• Experience in Immunology is highly preferred.

Technical Skills

Thorough understanding of both theoretical and practical aspects of Project Management. Strong Project Management skills across all phases of a project. In depth knowledge of MS Project and other portfolio/ schedule management tools. Excellent communication skills (written, verbal, listening, and presentation). Strong experience using Microsoft Office Suite including Word, Excel, and Power Point.

  Non-Technical Skills

Highly motivated and great attention to detail. Strong endurance to work under tight timelines and complex/changing situations. Excellent written and oral communication skills. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility. Cultural sensitivity and ability to develop consensus within a multinational organization. Capable of building cross-functional, cross-regional quality working relationships.

Physical Demands:

• Flexibility in working hours to accommodate travel and meetings; and international Global Team engagement, flexible time zones and work hours (as needed).Sitting at a workstation.


• Working Conditions: Regional & International Travel as required up to 20% of time

The anticipated salary for this position will be $146,000 to $185,200. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match


• Annual Bonus Program (Sales Bonus for Sales Jobs)


• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days


• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)


• HSA & FSA Programs


• Well-Being and Work/Life Programs


• Life & Disability Insurance


• Concierge Services


• Long Term Incentive Program (subject to job level and performance)


• Pet Insurance


• Tuition Assistance


• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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