CDMA Operations Project Manager (Local Candidate Preferred)

The Company:

It's not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You'll find that rare opportunity at PharmaEssentia. Join us, and let's transform lives, together.

PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one approved product and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (TPEx: 6446) and are expanding our global presence with operations in the U.S., Japan, China and Korea, along with a world-class biologics production facility in Taichung.

Position Overview:

The Clinical Development and Medical Affairs Operations Project Manager will be responsible for maintaining timelines across assigned CDMA projects that are aligned with key corporate milestones, developing and maintaining deliverables, implementing processes and tools that help utilize agile project management practices. The CDMA Project Manager will work closely with the Head of CDMA Operations to successfully plan, implement, and execute assigned projects, working with the cross-functional team to ensure timely delivery. This includes, but is not limited to the management of vendors, vendor contracts and budgets, as well as internal and external partners. The CDMA Project Manager assures clear team communication, process documentation, and compliance with SOPs and Good Clinical Practices (GCP) and ICH guidelines.

Key Responsibilities:

• Oversight of vendors and delegation of support staff activities.
• Support CDMA projects and work with cross-functional teams to achieve success.
• Be involved and aware of major milestones for assigned project(s), identify potential risks before they happen, and guide project team on mitigation.
• Ability to work independently to resolve issues, identify when to escalate an issue to management tracking all action items through issue resolution.
• Identifies potential obstacles to the successful completion of the project; analyzes information and develops innovative solutions to challenges.
• Maintains departmental document files, uploading documents to the collaborative workspace.

• Participates in reviews of CDMA project plans, documents, SOPs, operational guidance documents, when applicable.
• Assists with developing, documenting, and updating internal processes and SOPs
• Management of all activities from vendor selection through project close out, including, but not limited to assist with vendor selection, project scope, timelines, and budget development, invoice review, and oversight in development of project specific documents.
• Maintains current knowledge of FDA regulations, GCP and ICH Guidelines for clinical research, Medical Affairs compliance regulations to assist the cross-functional team as needed.
• Partner with Clinical Development, Quality Assurance, and Regulatory Affairs to help maintain inspection readiness within the CDMA organization.
• Assists with the scheduling, organization, and execution of CDMA team meetings, developing agendas, drafting minutes, and tracking action items.

Requirements & Experience

• Bachelor's Degree, life sciences preferred.
• Certification in a related allied health profession from an appropriately accredited institution, highly preferred.
• 2+ years' project management experience or equivalent.
• 8+ years' pharmaceutical/biotechnology industry or CRO experience, clinical trial experience strongly preferred.
• Strong communication skills (verbal, written and presentation) to express complex ideas.
• Detail oriented, excellent, and demonstrated organizational and interpersonal skills.
• Working knowledge of Word, Excel, and PowerPoint, Microsoft Project, SharePoint, and SAP preferred.
• Prior experience with budget development, forecasting, accrual tracking, financial reporting, and contracting and financial management platforms.

Benefits of working with our team:

PharmaEssentia USA strives every day to improve the lives of patients as well as our employees.

As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $100 monthly cell phone allowance
• Employee Assistance Program

EEO Statement:

At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.