Global Labeling Manager

Il y a 4 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**
- Coordinate and work collaboratively with product teams to maintain** up to date **Company Core Data Sheet (CCDS) **for assigned products**:

- Circulate or present CCDS updates to labelling committee to obtain internal approval, escalate significant labelling issues, as appropriate
- Manage and disseminate CCDS updates to defined stakeholders within required timelines and as per agreement with partners, as appropriate
- ** Work closely with GRA Compliance group and GRA teams to ensure oversight of CCDS updates for assigned products in Ipsen territory by ensuring a follow up of local PI submissions as per CCDS defined timelines**:

- ** Oversee the development of local labelling content for assigned products with respect to CCDS, as applicable across regions. Interacts with Global and Local Regulatory Affairs teams to ensure timely implementation of CCDS changes into local product information that are consistent with the company's position defined in the CCDS and in compliance with local labeling regulations. Supports Global/ local Regulatory Affairs (GRA/LRA) to** report non-conformances (non-alignment with required CCDS changes) or deviations when applicable**:

- Work with the Global Regulatory Affairs Therapeutic Area (GRA TA) and Submission team on planning,

managing and implementing labelling updates
- Maintain and catalog all labelling materials in accordance with company policies, procedures, and

technologies
- Participate in other projects and activities, such as contributing to the implementation of changes to

processes within GRA Labelling
- Ensure global labelling documents are of the highest quality and represent the safe and effective use of

the product
- Provide input for the production of high-quality documents supporting changes to the CCDS or local product information with internal and/or external experts including responses to labelling-related Health Authority queries
- ** Review worldwide labelling against the CCDS and facilitate and track implementation of changes to align with core content**:

- ** Provide overview and escalate significant labelling issues to labelling Head, ELC or Global Safety Compliance/Pharmacovigilance committees, as appropriate**:

- **Maintain all labelling documents in accordance with Ipsen company policies, procedures and technologies : ensure a thorough pre-review of labelling package before ELC and Issuance Notification (IN) before CCDS dissemination for assigned products. Provide QC for products from labelling staff, as required**:

- ** Participate to continuous improvement within Global Labelling**:

- ** Participate in label-related Health Authority negotiation meetings upon GRA TA request.**:

- ** Review **approved PI and** final artwork when key safety changes are to be implemented into production, as requested or **on ad-hoc basis.**:

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

- ** Assist GRA/LRA in preparation of responses to labelling-related Health Authority queries and track team decisions/HA negotiations**:

- ** Ensure deviations from labeling procedures and policies are addressed appropriately and escalated to Labelling Head or head of Function as appropriate.**:

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

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

**_ Please note: The list of activities mentioned above is not exhaustive and may evolve over time in accordance with the role and the needs of the company._**

**Knowledge, abilities & experience**

Education / Certifications:

- BS degree in life sciences/**scientific discipline (not limited to Pharmacy, Medicine, Safety, Biological Sciences, Medical Writing)**:

- Global regulatory/ labelling experience - familiarity with labeling regulations in other countries/ region

(e.g. USA, EU, Japan, China) is desired
- ** Good knowledge of EU & US labelling regulations/guidelines. Good overview of other country/region labelling is desired**

**Experience**:

- ** Regulatory professional with 7-9 years of industry experience and relevant experience with focus on labelling (experience with global labelling activities, management of prescriber, patient and pack information)**:

- Scientific Regulatory/Medical Writing, **Project Management experience**

Langu

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