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Global Labeling Manager Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

GLOBAL LABELING MANAGER needed for a CONTRACT opportunity with Yoh's client located in Gaithersburg, MD.

WHAT YOU'LL BE DOING:

- The Global Labeling Manager (GLM) provides regulatory labeling expertise to GRAPSQA and cross-functional teams, under the leadership of the Global Labeling Director.
- The GLM will lead or assist in the development/production and maintenance of defined global labeling documents (marketed or pipeline) for products.
- Additionally, the GLM supports the daily activities of the Global Labeling Director and Global Labeling Associate Director.
- Ensure the integrity of labeling processes is maintained.
- Contribute to development of global labeling strategies for assigned products.
- Provide labeling expertise to product labeling teams regarding language, placement and regulatory content detail for regional prescribing information and CDSs.
- Lead or contribute to the development of target labeling documents, under Director or Associate Director Supervision.
- Prepare and maintain core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet.
- Contribute to or lead cross functional teams in preparation and maintenance of EU SmPC and US PI and related texts while ensuring consistency with applicable core labeling documents and internal standards and SOPs.
- Provide advice and support for the creation and maintenance of other regional texts on an ad hoc basis.
- Lead or contribute to development of labeling negotiation strategies.
- Manage corporate review and approval of CDSs, USPIs, EU SmPCs and other regional prescribing information.
- Provide support to address general labeling issues.
- Participate on and provide regulatory advice to cross-functional teams responsible for the coordination of the implementation of new and revised labeling components into the production activities of multiple manufacturing sites.
- Ensure relevant changes to the labeling texts are accurately implemented into the package components where appropriate.
- Develop, review, and approve artwork for packaging components (all US products and applicable EU countries) to facilitate implementation into production activities.
- Evaluate, interpret, and communicate global regulations and trends on labeling and any business impact these might have on product labeling.
- Monitor competitor labeling activities and provide updates to GRAPSQA.
- Provide labeling support and contributions for regional regulatory maintenance activities (PSURs, annual reports, etc.).
- Communicate availability of new and revised regional labeling documents to appropriate functions throughout the business.
- Establish and maintain repositories of current regional labeling documents for access by individuals across all business functions.

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS in Science or related discipline
- Advanced academic training is highly desirable (PharmD, PhD)
- Three (3) years pharmaceutical experience, preferably regulatory experience, preferably working with labeling
- Knowledge of labeling regulations and guidance
- Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
- Ability to assimilate clinical and scientific information and present it in a concise manner
- Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

Must demonstrate competencies in:

- Building Relationships (works well across formal and informal networks)
- Negotiation Skills (good listener; able to build a consensus)
- Critical Information Seeking (works well across formal and informal networks)
- Rational Persuasion (able to distil an issue to its key components and suggest solutions)
- Interpersonal Awareness (aware of how actions affect other people)
- Experience in Labeling development and/or maintenance

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Gaithersburg, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh

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