Project Coordinator - Compliance, Training and Strategic Alliance

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Essential Functions Required for Job

• Coordinate and schedule alliance partner meetings, including preparation of agendas, meeting materials, and distribution of minutes.
• Maintain communication channels with partners and ensure pharmacovigilance interactions are accurately documented and tracked.
• Triage CTSA mailbox inquiries, route messages to appropriate contacts, and escalate urgent safety communications to prevent delays in AE reporting.
• Maintain accurate records and ensure proper handling, retention, and archiving of PVRM documentation in electronic repository to support compliance, document control, and inspection readiness.
• Review contracts submitted through the electronic contract repository to ensure appropriate pharmacovigilance and safety language and identify or escalate compliance risks or gaps.
• Serve as the primary point of contact for contract repository notifications involving vendors and manage contracts.
• Track Statements of Work timelines, PV reconciliation, and vendor training needs in the Project Tracker and ensure AE/PC related vendor training and compliance.
• Monitor the progression of pharmacovigilance agreement (PVA) comments to ensure timely follow‑up and adherence to deadlines.
• Coordinate and schedule PVRM / CTSA internal meetings, including preparation of agendas, meeting materials, and distribution of minutes.

Knowledge, Skills and Abilities (general & technical):

• Organizational & Project Management Skills – Ability to juggle multiple priorities.
• Excellent written communication skills – Clear, concise written communication.
• Excellent verbal communication skills and interpersonal skills – engage confidently with partners, stakeholders and vendors.
• Technical & Systems Proficiency - Inbox triage and workflow management.
• Analytical & Critical Thinking – Ability to assess completeness and accuracy of PV documentation.

Education & Experience Requirements:

• Bachelor’s degree
• Minimum of 2 years of project coordination or project management experience, preferably within a pharmaceutical, biotech, CRO, or other regulated environment.

• Preferred Qualifications:
• Exposure to pharmacovigilance or safety operations (direct or indirect) is a plus.
• Demonstrated experience coordinating cross‑functional deliverables, tracking timelines, action items, and dependencies, and driving follow‑up to completion.

Other Requirements (licenses, certifications, specialized training, and physical or mental abilities required):

• N/A

Travel Requirements:

• Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

• Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

• This is an individual contributor role and does not have direct reports or formal people‑management responsibilities.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes up to 120 hours of vacation per year, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter and access to our service recognition program.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.