Regulatory Chemistry Manufacturing and Controls Expert
2 semanas atrás
Job Description
The Position
The Associate Director (Associate Principal Scientist), Organon, Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects. The individual may also support project team goals and organizational initiatives on an as-needed basis.
This will include oversight and monitoring of assigned CMC project timelines. This position will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress to achieve project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead for making strategy for projects.
This position will also be responsible for working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report, and act on delivery performance and quality of deliverables.
The incumbent requires in-depth knowledge and skills in CMC strategy, with strong capability in project management. The successful candidate requires a strong track record of demonstrated knowledge of CMC life cycle management and eCTD.
Responsibilities
Managing processes and connections between the external partners and the various stakeholders within CMC.
Serving as the CMC Lead for assigned Global Network projects and being accountable for the delivery of all regulatory milestones.
Overseeing the preparation and submission of Global CMC dossiers for assigned Network projects.
Cultivating and fostering collaborative relationships with internal and external partners to drive on-time, high-quality delivery of business commitments.
Actively monitoring, facilitating, reporting, and communicating progress against agreed timelines and proactively resolving issues to enable delivery of high-quality, on-time submission information.
Escalating potential delays or performance issues in a timely manner to impacted cross-functional stakeholders.
Managing communication and change management within the internal organization.
Providing CMC support for Legal Entity Change (LEC) project.
Required Education, Experience, and Skills
Bachelor's degree in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry - minimum seven years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field.
Or advanced degree (MS, MBA, Ph.D., PharmD) - minimum four years of relevant experience including biological/pharmaceutical research, manufacturing, testing, or a related field.
Strong negotiation, interpersonal, written/oral communication skills and fluency in the English language
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