Senior Manager, GPS Functional Project Management

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Sr. Manager, GPS Functional Project Management will develop, implement and maintain Global Patient Safety (GPS) project management capabilities to assure the successful completion and practical implementation of strategic GPS initiatives, in addition to supporting the preparation of key GPS deliverables including procedural documents, templates, processes and reviews.

Business and Project Management:

• Function as the point of contact for strategic GPS projects and other initiatives related to drug safety and pharmacovigilance

• Serve as subject matter expert regarding project management

• Lead, support and maintain an oversight on ongoing GPS project management activities

• Work aligned with processes and tool utilization within PPM’s Portfolio Operations Improvement Center, and coordinate with other functions and/or GPS management to ensure consistency and best practices regarding project management

• Contribute to process improvement and tool optimization at PPM as applicable to enhance GPS-oriented project management

• Prepare and maintain project management plans in the current project management tooland associated documents.

• Assure that tasks are assigned and completed according to quality expectations and required timeliness

• Assure systematic documentation, tracking and archiving for all GPS projects

• Establish, facilitate, and maintain regular interactions with other departments, program teams and other cross functional groups with regard to communication of safety data and processes that involve GPS

• Establish RACI, manage project timelines, and track deliverables

• Prepare, maintain and present project status reports regularly

• Monitor resource utilization metrics, identify opportunities for synergies and communicate to Head of GPS

• Work closely with GPS management contributing to the prioritization and planning of strategic projects

• Support GPS budget and resource planning as needed

• Identify project risks and ensure that contingency or mitigation plans are created and implemented in order to assure successful project completion

• Propose innovative solutions and practices as applicable

Safety/Pharmacovigilance:

• Support the preparation of GPS documents and processes (including SOPS, work instructions, PSMF, pharmacovigilance agreements or signal detection)

• Support GPS inspections and internal audits

• Collaborate with GPS leadership on the development of processes related to pharmacovigilance operations, systems, and other activities

• Work closely with GPS colleagues to obtain, develop and maintain various GPS analysis, forecasting and tracking tools

• Maintain working knowledge of GPS contractual documents, monitor status, coordinate and communicate updates as applicable

• Assist with preparing and coordinating responses to regulatory authorities or other external requests as needed

• Maintain knowledge of regulatory requirements globally as applicable to drug safety and pharmacovigilance

SKILLS ANDCOMPETENCIES

• Excellent planning and organizational skills

• Excellent oral and written communicationskills including ability to communicate complex issues

• Demonstrated ability to prioritize, adjust, and manage multiple projects simultaneously

• Advanced writing and presentations skills

• Solution oriented with ability to work independently

• Ability to function effectively in a team environment

• Advanced computer skills, including proficiency with MS Office and project management tools including Microsoft Project, Visio

• Fluency in written and spoken English

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• At least Bachelors’ degree (or country equivalent) in related scientific fieldrequired

• At least 7 years of experience in the pharmaceutical/biotechindustry in drugsafety/pharmacovigilance or related field

• At least 3 years of experience in project or program management

• Proven ability to successfully collaborate and co-create cross-functionally including managing vendor relationships

• Experience with regulatory submissions and medical writing is preferred

• Fundamental knowledge of pharmacovigilance regulatory requirements is required

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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Originally posted on Himalayas