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Scientific Expert
Há 1 mês
Job Title: Scientific Expert - Regulatory Affairs Leader
About Organon:
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We deliver ingenious health solutions that enable people to live their best lives. Our Vision is clear: A better and healthier every day for every woman.
Estimated Salary Range: $160,000 - $200,000 per year
Job Description:
The Scientific Expert - Regulatory Affairs Leader 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 as needed.
This role will involve oversight and monitoring of assigned CMC project timelines. The Scientific Expert - Regulatory Affairs Leader will work alongside CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards achieving project goals.
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.
Responsibilities:
- Manage processes and connections between external partners and various stakeholders within CMC.
- Serve as the CMC Lead for assigned Global Network projects and be accountable for the delivery of all regulatory milestones.
- Oversee preparation and submission of Global CMC dossiers for assigned Network projects.
- Cultivate and foster collaborative relationships with internal and external partners to drive on-time high-quality delivery of business commitments.
- Actively monitor facilitate report and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality on-time submission information.
- Escalate potential delays or performance issues in a timely manner to impacted cross-functional stakeholders.
- Manage communication and change management within the internal organization.
- Provide CMC support for Legal Entity Change (LEC) project.
Required Education Experience and Skills:
- Bachelor's degree in a science engineering or related field such as Pharmacy Chemical Engineering Biology Microbiology Virology Molecular Biology Biochemistry.
- Or advanced degree (MS MBA Ph.D. PharmD) - minimum 4 years of relevant experience including biological pharmaceutical research manufacturing testing or a related field.
- Strong negotiation interpersonal written/oral communication and fluent in English language.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project Management.
- Good understanding of change management projects.
Preferred Education Experience and Skills:
- Degree in pharmacy biopharmaceutics analytical chemistry organic chemistry chemical engineering or a related discipline.
- Direct experience in Regulatory CMC.
- Demonstrated experience driving change initiative projects.
Benefits:
As an equal opportunity employer Organon welcomes applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
