Packaging Investigator Stellenangebote

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6 Stellenangebote

Stellenangebote Packaging Investigator Jobs bei Jobleads

Job vom 27.01.2025

Medical Director (m/w/d)

Führungs-/ Leitungspositionen

MEHR

[...] needs and local customer insights, championing affiliate medical best practices and learnings with peers from other LEO Pharma affiliates Represent Medical Affairs in Leadership teams and contribute beyond the medical agenda Governance Compliance Responsible for local sign- off of proposed Investigator Initiated Studies (IISs) and Non- Interventional Studies (NISs) in the affiliate prior to submission for global review Maintain highest standards [...] of the information officer in accordance with the German Medicines Act (AMG) , verifying the content of advertising material for compliance with the content of the registration and for medical correctness (reported to the Darmstadt Regional Council) . Responsibility for packaging materials is delegated to the Head of RA. However, the main responsibility as information officer lies with the incumbent. Your [...]
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Job vom 27.01.2025 Medical Director (m/w/d) • Neu- Isenburg, Hessen Führungs-/ Leitungspositionen

MEHR

[...] needs and local customer insights, championing affiliate medical best practices and learnings with peers from other LEO Pharma affiliates Represent Medical Affairs in Leadership teams and contribute beyond the medical agenda Governance Compliance Responsible for local sign- off of proposed Investigator Initiated Studies (IISs) and Non- Interventional Studies (NISs) in the affiliate prior to submission for global review Maintain highest standards [...] of the information officer in accordance with the German Medicines Act (AMG) , verifying the content of advertising material for compliance with the content of the registration and for medical correctness (reported to the Darmstadt Regional Council) . Responsibility for packaging materials is delegated to the Head of RA. However, the main responsibility as information officer lies with the incumbent. Your [...]

Weitere Stellenangebote Packaging Investigator bei Jobleads

Job vom 25.01.2025

Lead Medical Director Neuroscience

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

[...] interactions providing clinical science information such as the development of briefing packages and responses to HA questions with little to no supervision from more experienced Medical Directors. Collaborating with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials. Collaborating with relevant team members to measure and monitor study progress against objectives and plans, [...] an active role with other CST members, regulatory and other internal partners/ stakeholders in completing and submitting regulatory filings and other regulatory documentation. Providing clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc. Collaborating with relevant team members and clinical operations to close out clinical studies, secure data and complete study [...]

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Jobs aus Neuvoo

Stellenangebote Packaging Investigator Jobs bei Neuvoo

Job vom 07.03.2025 OSB AG

CTS Packaging Labelling Specialist (all gender)

• Marburg, Hesse
Vergütung / Gehalt: EUR 0,-

MEHR

Scientific. Make it happen YOU. . . are responsible for planning and coordinating the labeling, packaging, and release of investigational medicinal products (IMP) for global clinical programs, including Investigator Initiated Trials (IITs) ensure regulatory compliance in IMP label text translations and providing consultancy to CTS study teams on packaging [...]

Stellenangebote Packaging Investigator Jobs bei NewScientist Jobs

Job vor 2 Tagen gefunden Ventus Therapeutics

Associate Director, Clinical Operations

• Waltham, Massachusetts, United States, Waltham Führungs-/ Leitungspositionen

MEHR

[...] and other governing regulatory bodies) Develops, review and approve Quality Documents Oversees the development of site clinical trial agreements and other relevant documents Reviews, contribute and/ or author the creation and finalization of key trial documents: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc. Liaises with clinical site staff and Investigators as [...] to develop and ensure execution of activities outlined in various study plans s (e. g. data management, risk management, safety management, and study communication plans) Partners with CMC/ clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials Leads, plans, and executes clinical Investigator meetings, study meetings, and vendor meetings as needed Contributes [...]
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Job vor 2 Tagen gefunden Gilead Sciences, Inc.

Associate Director, Global Regulatory Affairs, Oncology

• Cambridge, United Kingdom, Cambridgeshire Führungs-/ Leitungspositionen

MEHR

[...] other Regulatory Project Teams and represent Global TA Regulatory on cross- functional core and sub- teams. You will typically serve as a Gilead contact to/ for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You [...] of regulatory submissions, which require cross- functional interactions for commercial or investigational product (s) . Examples include meeting requests, briefing packages, original Investigational New Drug (IND) , IND amendment, and routine submissions (e. g. , Development Safety Update Reports/ DSURs, Investigator Brochure/ IB updates, etc. ) . Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents [...]
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Medien und Werbung Design und Mediengestaltung

Dauer: 0.1892 s., Vers. V.2025-a-2005-Ind-141