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    Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (Cmc)

    Organon
    7+ years
    Not Disclosed
    Remote
    10 Oct. 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Associate Director (Associate Principal Scientist), CMC - Organon Manufacturing & Supply

    The Position:

    As the Associate Director (Associate Principal Scientist) within the Organon Manufacturing & Supply (OMS) team, you will provide regulatory Chemistry, Manufacturing & Controls (CMC) support for Organon Network Projects. This role is pivotal in leading the preparation and submission of CMC dossiers for assigned projects, while also contributing to team goals and organizational initiatives as required.

    You will oversee and monitor CMC project timelines, collaborating closely with CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals. Additionally, you will support the Network Project CMC Lead in strategizing project approaches.

    In this position, you will work with outsourced partners aligned with the OMS CMC outsourcing strategy, proactively collaborating to monitor delivery performance and quality of outputs.

    Responsibilities:

    • Manage processes and connections between external partners and internal CMC stakeholders.
    • Serve as the CMC Lead for assigned Global Network projects, accountable for achieving all regulatory milestones.
    • Oversee the preparation and submission of Global CMC dossiers for designated Network projects.
    • Cultivate and maintain collaborative relationships with internal and external partners to ensure timely and high-quality delivery of business commitments.
    • Actively monitor, facilitate, and communicate progress against agreed timelines, proactively resolving issues to ensure high-quality submissions.
    • Escalate potential delays or performance issues promptly to relevant cross-functional stakeholders.
    • Manage communication and change management within the organization.
    • Provide CMC support for Legal Entity Change (LEC) projects.

    Required Education, Experience, and Skills:

    • Bachelor’s degree in a science, engineering, or related field (e.g., Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology) with a minimum of 7 years of relevant experience in biological/pharmaceutical research, manufacturing, or testing; or
    • Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience in similar fields.
    • Strong negotiation, interpersonal, and communication skills, with fluency in English.
    • Proven ability to lead by influence and work effectively within matrix organizational structures.
    • Project management experience.
    • Good understanding of change management processes.

    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 in driving change initiatives.
    • Experience with OCMC processes.

    About Us:

    At Organon, we are dedicated to delivering innovative health solutions that empower individuals to live their best lives. With a commitment to Women’s Health, we are a $6.5 billion global healthcare company focused on addressing unmet needs and expanding access to essential treatments.

    We are an equal opportunity employer, welcoming applications from diverse backgrounds and fostering an inclusive environment for all candidates.

    Search Firm Representatives: Unsolicited assistance from search firms is not accepted. All submissions without a valid agreement will be considered the sole property of Organon.

    Travel Requirements: Employees must meet all applicable travel and credentialing requirements.

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