Global Labelling Manager

Il y a 2 mois

Les Ulis, France Ipsen Innovation (SAS) Temps plein

**Summary / purpose of the position**

**To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)**

**To provide labelling guidance to support product teams and senior management in defining labelling strategy**

**To provide oversight of global labelling activities for assigned products**

**To contribute to the development of the labelling function and the implementation of labelling processes**

**To guide teams to ensure compliance with SOPs**

**Main responsibilities / job expectations**
- **Leads and works collaboratively with submission/product teams to develop & maintain Company Core Data Sheet (CCDS) and other key global labelling documents for assigned products**:

- **Provides strategic guidance on labelling requirements and labelling trends, gets alignment on proposed wording**:

- **Presents to Executive Labelling Committee (ELC) with product team or circulates CCDS updates (in conjunction with EU-USPI updates when required) to obtain internal approval or escalate significant labelling issues, as appropriate**:

- **Manages and disseminates CCDS updates to defined stakeholders within required timelines and as per agreement with partners, as appropriate**:

- **Works closely with GRA Compliance group and Global Regulatory teams to ensure oversight of CCDS updates in Ipsen territory by monitoring timely implementation in countries**:

- **Supports Global and Local Regulatory Affairs teams for the implementation of CCDS content in local product information and reporting of non-conformances (non-alignment with required CCDS changes)**:

- **Works with the Global **Regulatory/Submission** teams on planning, managing and implementing labelling updates**:

- **Maintains all labelling documents in accordance with Ipsen company policies, procedures and technologies**:

- **Participates in other projects and activities for the implementation of changes to processes within Global Labelling**:

- **Ensures Global Labelling documents are of the highest quality and represent the safe and effective use of the product**:

- **Provides input for the production of high-quality documents supporting changes to the CCDS**:

- **Manages CCDS annotations and check consistency with source documents and within CCDS sections**:

- **Assists in preparation of responses to labeling-related Health Authority queries**:

- **Reviews and approves non-conformances from CCDSs; ensures deviations from labeling procedures and policies are addressed appropriately and escalated to ELC as appropriate**:

- **Represents labelling on product-specific global regulatory subteams**:

- **Participates to mandatory trainings and completes training records**

**Knowledge, abilities & experience**

Education / Certifications:

- **Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Safety, Biological Sciences, Medical Writing)**:

- **Graduate degree in Regulatory or related discipline preferred**:

- **Familiarity with labelling regulations in other countries/region (e.g. USA, EU, Japan, China) is desired**

**Experience**:

- **Minimum of 7 years of experience in global labelling activities or management of EU/US product information**:

- **Experience in **Pharma/biotechnologies** and Global labelling - Knowledge of labelling within a Therapeutic area**:

- **Regulatory, safety, scientific, or medical writing experience**:

- **Project Management experience, experience managing individual and group projects of moderate complexity**

Languages:

- **Fluency in English as business language**

**Key Technical Competencies Required**
- **Regulatory Affairs experience is essential with direct experience managing CCDSs, labeling submissions and related activities: experience and working knowledge with SPL and PLR requirements and/or SmPC and QRD requirements**:

- **Knowledge of pharmaceutical regulation related to product information in EU and US and ability to maintain awareness of new external guidelines/policies pertaining to product information**:

- **Excellent writing skills especially suitable for labelling, proven experience in drafting labelling content**:

- **Data analysis skills and high level of attention to detail - ability to work proactively through labelling revisions and the product review process**:

- **Knowledge of therapeutic area(s) and be able to develop a sound knowledge of a product portfolio**:

- **Strong collaboration, presentation, communication and interpersonal skills with ability to establish effective working relationships with a diverse range of stakeholders**:

- **Proven project management, leading teams from multiple functional areas**:

- **Excellent verbal and written communication skills; strong technical writing and presentation skills**:

- **Strong scientific background and/or experience, working knowledge of medical terminology

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