Job Description
Job Description:
- The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed products assigned to obtain company and/or agency approval.
- Developmental of labeling for these products is based on study results, coordination or labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies and participation in labeling negotiations with agencies resulting in product approvals or labeling updates.
- The position also includes subject matter expertise in specific labeling regulations (e.g. OTC rules) and review of local labeling to assure compliance with corporate labeling.
- Knowledge of European and US regulations and international regulatory environment.
- Knowledge of labeling regulations (US, EU and Global).
- Experience as labeling manager.
Skills:
- Excellent written and verbal communication skills.
- Demonstrated ability to solve problems and proactivity.
- Ability to work with multifunctional and culturally diverse teams.
- Organizational skills, ability to manage multiple projects at short notice.
- Excellent inter-personal skills.
- Autonomy.
- Rigor.
- Fluent business English.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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