Global Labeling Manager 100% m/f - This challenge is waiting for YOU!
For our customer, a pharmaceutical company located in Basel, and for a temporary assignment starting in January 2019 till July 2019 (maternity leave), we are looking for a
Global Labeling Manager 100% m/f
The purpose of the Global Labeling Manager within global Regulatory Affairs (RA) is to assure world-wide harmonized product information and to ensure that product labels properly comply with company core data sheets and/or other core labeling documents and the respective processes.
This is in order to provide health care professionals and patients/ customers with appropriate information on our products and to safeguard with regard to liability issues and to ensure competitiveness of labeling documents.
Major tasks and responsibilities of position
- Manages core labeling documents (health care professional information and patient information leaflet) for assigned products in order to present all relevant data concerning a particular product in a comprehensible form to enable the different countries to produce, based on these, their HCP information and their patient information leaflet.Perform timely creation of CCDSs for development products (NPDs) and manage their maintenance for marketed products, observing legal regulatory requirements and taking into account for the current medical and scientific knowledge in close co-operation with the relevant expert functions.
- Manages cross-functional expert teams for the assigned products which jointly discuss the latest results and potential signals relevant to the products and their possible inclusion in the core labeling documents.
- Providing input to Regulatory Submission Strategies from labeling point of view.
- Ensures availability of up to date labeling documents and related documents in a global labeling database.
- Coordination and contribution to/ conducting the evaluation of local labeling deviations in order to monitor harmonization of world-wide product information. Initiation of corrective measures where possible and analyzes the possible impact of deviations on the core labeling documents. C
- Support and educate experts, regional functions and affiliates with regard to labeling issues incl legal requirements and labeling guidelines and support regions/ affiliates in the implementation of the CCDSs into local labeling documents.
- University Degree in Pharmacy, Regulatory Affairs, or Life Sciences.
- At least five years of experience in a role within the pharmaceutical industry (preferably within R&D functions such as Regulatory Affairs, Medical, Labeling or Pharmacovigilance)
- The position requires expert knowledge of and adherence to legal regulatory regulations, especially as they apply to compliance, to support labeling-related regulatory activities. Scientific and technical expertise is an advantage. Analytical regulatory skills are necessary. The incumbent should have skills and preferably experience in dealing with Health Authorities.
- The job holder should be familiar with medical terminology and should have some knowledge of drug safety. The job holder should be able to support the transformation of medical terminology into patient friendly wording.
- Soft skills:
- Customer orientation
- The ability to work within a global team framework and a multi-cultural environment is required.
- He/she must have well developed project management skills, including interpersonal skills.
- Good communication skills, verbal and written are imperative. Ability to communicate effectively in English verbally and in writing
- Must be able to work focused and target oriented in a complex scientific/ technical environment.
- The job holder must be able to absorb large amounts of information efficiently, give sound judgements and act professionally in order to manage difficult problems effectively.
- Be able to work on multiple projects in parallel. Must have the capability to organize and direct diverse activities in a changing environment, often under time pressure.
- Networking and influencing skills. The job holder must be able to successfully negotiate with stakeholders of the process in different departments.
- Proficiency in MS Office: Word, Excel, PowerPoint; being familiar with use of databases (eg Citrix-based, Oracle-based)
This exciting challenge is waiting for an expert! Our you the one? If so, please send in your application to Rahel Lobstein: firstname.lastname@example.org.
Tel: +41 61 201 18 09