Category: Research & Development| Country: United Kingdom | City: Oxford | Type: Regular, Full Time | Job ID: 4298
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Director, Labeling is a member of Global Regulatory Affairs at Jazz Pharmaceuticals and is responsible for the leadership and oversight of labeling for products marketed globally. This position will have line management responsibilities across the Global team. This position serves as an internal expert on the content of Core Data Sheet and local labels and labeling (including EU SmPC and RoW Product Information). Reporting to the Senior Director, Global Labeling, this position must be capable of representing the labeling perspective and applying expertise and organizational influence with cross functional teams and will work collaboratively with the Clinical, Medical, Legal, Compliance, Safety, Commercial Quality and Supply Chain organizations. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of labeling processes.
- Lead, develop and manage employees and resources needed to support Global labeling activities to support business needs, including oversight of staffing, personnel development and training, as well as management of resources and budget.
- This position will be accountable for ensuring the completion of key labeling functions with primary focus on Company Core Data Sheets and regional/local labeling for products marketed globally. Accountabilities will be met through individual contribution and management of staff responsible for certain activities.
- Provide regulatory consultation and strategy to business functions during development of target product profiles for development programs as well as for labeling development needs
- Oversee the entire labeling process, from the decision to update a CCDS/SmPC for assigned product(s) through implementation of changes of local package inserts and equivalents and their associated Patient Labeling Documents, to ensure that labeling documents are reviewed, approved and produced in a high quality and timely manner according to internal SOPs and external regulatory requirements
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations as they pertain to the development/maintenance of labeling: and advise key stakeholders on the application of these labeling principles, including recommendation of policy and/or process changes as needed
- Provide strategic advice in the development of labeling text, including contingency strategy development for negotiation with regulatory authorities
- Support regional and local affiliates by developing a network of regulatory and medical contacts, acting as consultant in regulatory and code compliance matters, supporting local affiliates in promotional complaints, supporting the development, integration and update of local affiliate processes and standards for promotional material review and determining the training needs for International stakeholders
- Lead and manage interactions with internal (e.g., Commercial, Medical, Legal/Compliance, and R&D Functions) and external (e.g. EMA, and other Regulatory Authorities for labeling interactions) as required
- Identify and implement process improvements as required in the spirit of a continuous pursuit of excellence
- Schedule, coordinate and lead LC meetings, schedule and coordinate ELC endorsement
Required Knowledge, Skills, and Abilities
- Minimum of 10 years of increasingly responsible experience in the pharmaceutical industry, including at least 6 years of direct experience in Global Labeling and 3 years of experience in other regulatory affairs function(s)
- Extensive experience and knowledge in labeling and product information (including labeling texts for artwork content), including superior working knowledge of applicable SmPC Guideline and QRD requirements and practice.
- Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire company.
- Outstanding verbal and written communication skills and collaborative interpersonal skills.
- Demonstrated leadership success in management, including leadership of a team or group
- A proven track record of effective collaboration with regulatory agencies.
- A proven record of effective collaboration with cross-functional teams.
- Evaluative, analytical, and interpretative skills, enabling review and synthesis of reports and other documents used in promotional regulatory strategy and submissions.
- Ability to travel occasionally – approximately 10-20% regional and/or international travel
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Required/Preferred Education and Licenses
- Bachelor’s degree required (Scientific discipline preferred)
Jazz Pharmaceuticals is an Equal Opportunity Employer.