Global Labeling Manager

Major Responsibilities

• Manage Company Core Data Sheets (CCDSs) and their annotated versions and Company Patient Information (CPI) in order to present all relevant data concerning a particular product (chemical, pharmaceutical, pharmacokinetic, pharmacodynamic, preclinical, medical, drug safety) in a comprehensible form, to enable the different countries to produce, based on these, their prescribing information for health care professionals and their patient information.
• Perform timely creation of CCDSs for development products (incl. Target labeling) and manage their maintenance for marketed products (change management), observing legal regulatory requirements and taking account the current medical and scientific knowledge in close co-operation with the relevant expert functions.Manage Product Evaluation Teams (PET). These interdisciplinary committees of experts jointly discuss the latest results relevant to the products and their possible inclusion in the CCDS.
• Introduce standardised labeling processes and create and maintain labeling standards.
• Manage the implementation of labeling changes, agreed by the Global Labeling Committee (GLC).
• Following decision by the GLC, initiate and audit implementation of product information changes into local labeling documents in all countries where the product is registered and ensure timely submission by affiliates (invoke escalation procedure where required)
• Evaluation of Labeling Compliance Forms (LCF) in order to monitor harmonisation of BSP world-wide product information, take corrective measures where possible and analyze the possible impact of deviations on the global labeling documents
• Train and advise less experienced Global Labeling Managers and assistants in order to ensure consistency and quality of work.
• Ensures availability of up to date global labeling documents and related documents in a global labeling database
• 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
• Represent GRA Labeling in product labeling harmonization processes with other pharmaceutical companies.

Requirement

• The incumbent should have solid knowledge of the pharmaceutical industry, the company’s business practices and processes and products.
• Requires Ph.D., Pharm D, or MD in life sciences with 3 years experience in pharmaceutical industry (preferably within development functions)  Or MS degree in life sciences with 5 years industry experience (preferably within development functions) or BS degree in life sciences with 7 years industry experience (preferably within development functions).
• 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. The incumbent should be able to follow tight timelines covering regulatory procedures as they apply to labeling.
• The job holder should be familiar with medical terminology and should also have some knowledge of drug safety. The job holder should be able to support the transformation of medical terminology into patient friendly wording.
• Preferably, incumbent has a solid knowledge of company policies and procedures in drug development and maintenance.
• Analytical regulatory skills are necessary. The incumbent should have skills and preferably experience in dealing with Health Authorities.
• He/she must be able to work focused and target oriented in a complex scientific / technical environment. The incumbent will be required to focus on multiple issues simultaneously, and must have the ability to organize and direct diverse activities in a changing environment, often under time pressure.
• The position requires the ability to work in English. Command of German is an advantage.
• 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.
• The job holder must be able to successfully negotiate with stakeholders of the process in different departments. The job holder must be able to absorb large amounts of information efficiently, give sound judgments and act professionally in order to manage difficult problems effectively..