- Merck & Co. (North Wales, PA)
- …that the data evaluated are in high quality and satisfy analysis requirements .Collaborates with the statistical programming staff to ensure that all programs meet ... analysis requirements , internal standard operating procedures, and external regulatory ...and prohibit discrimination on the basis of race, color, age , religion, sex, sexual orientation, gender identity, national origin,… more
- Merck & Co. (Upper Gwynedd, PA)
- …to ensure alignment with clinical development timelines and regulatory requirements . Most importantly, the role requires overseeing CDx development, ensuring ... stay up to date regarding industry trends and diagnostic regulatory requirements . Essential Job Requirements :Develop end-to-end diagnostic strategy in… more
- Merck & Co. (North Wales, PA)
- …This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with ... in conducting clinical trials in ophthalmology, such as uveitis, AMD ( age -related macular degeneration), thyroid eye disease.Experience in developing protocols and… more
- Merck & Co. (North Wales, PA)
- …This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability to manage multiple competing priorities with ... in conducting clinical trials in ophthalmology, such as uveitis, AMD ( age -related macular degeneration), thyroid eye disease.Experience in managing and driving… more
- Merck & Co. (North Wales, PA)
- …to ensure compliance with the US Food and Drug Administration requirements for "Financial Disclosure by Clinical Investigators" for all marketing applications ... and Corporate Finance/Legal/Licensing Departments, (4) ensures compliance with regulatory requirements for reporting such information, (5) keeps current with… more
- Merck & Co. (North Wales, PA)
- …teams such as new statistical computing platform evaluation and development.Education requirements :Must have a Bachelor's degree (or US equivalent) in Computer ... plus 7 years SAS programming experience in a clinical trial environment. Requirements :Experience and knowledge in leading large and/or complex statistical programming… more
- Merck & Co. (Upper Gwynedd, PA)
- …gap between BAs/Stakeholders and Technical teamCollaborate with IT/vendors on business requirements for new or enhancement needs to support GCTO reporting.Build ... improvement to develop BI toolsVendor relationship management ensuring business requirements are clearly articulated and executed.Mentor and provide training to… more
- Merck & Co. (North Wales, PA)
- …departmental standards and industry best-practices.Ability to anticipate stakeholder requirements .** Preferred Skills and Experience: Strong working knowledge of ... for employment and prohibit discrimination on the basis of race, color, age , religion, sex, sexual orientation, gender identity, national origin, protected veteran… more
- Merck & Co. (North Wales, PA)
- …in local regulatory frameworks, ethical standards, and pharmaceutical compliance requirements .Proven capability to cultivate and sustain strategic partnerships with ... for employment and prohibit discrimination on the basis of race, color, age , religion, sex, sexual orientation, gender identity, national origin, protected veteran… more
- Merck & Co. (Upper Gwynedd, PA)
- …tools.Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements .Has delivered effective CAPA management solutions.Has worked with risk ... for employment and prohibit discrimination on the basis of race, color, age , religion, sex, sexual orientation, gender identity, national origin, protected veteran… more
