Associate Director, Global Labeling Product Leader

vor 1 Tag

Bern, Schweiz Johnson & Johnson Vollzeit

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Spring House, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug(Switzerland); or Remote work options may be considered, on a case-by-case basis and if approved by the Company.

Our company thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

Key Responsibilities:

- Have oversight and responsibility for the development, revision, review, approval and maintenance of primary and derived labeling documents for assigned compounds in assigned portfolio.
- Manage compounds with a certain degree of complexity from a labeling perspective.
- Create and maintain primary labeling documents - the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI) - and derived documents (labeling text for EU, US).
- Coordinate the development, revision, review and approval of primary and derived labeling documents, including the Labeling Working Group (LWG) and Labeling Committee (LC) activities related to these documents.
- Ensure the dissemination of LC-approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
- Contribute to and implement the global labeling strategy including the development of target labeling.
- Contribute to the continuous improvement of the end-to-end labeling process.

**Qualifications**

Education
- A minimum of Bachelor’s degree (or equivalent) (required)
- A degree in scientific discipline (highly preferred)
- An advanced degree (MS, PhD, MD or PharmD) (highly preferred)

**Required Skills**:

- Minimum of 8 years professional experience
- Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience or equivalent
- An understanding of prescription pharmaceutical drug development

Preferred Skills:

- Previous experience working within a regulatory labeling function developing labeling content for pharmaceutical products
- Experience working in documentum-based systems
- Experience leading project teams
- Solid understanding of biology and pharmacology
- A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, negotiation and partnering skills
- Demonstrated ability to drive a collaborative, customer-focused, learning culture

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

The anticipated base pay range for this position is $129,500 to $194,000 (US). Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

**Primary Location**
United States-New Jersey-Raritan-920 US Highway 202

**Other Locations**
North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Allschwil, North America-Canada, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-Canada-Ontario-Toronto, Europe/Middle East/Africa, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Berne-Bern, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States

**Organization**
Janssen Research & Development, LLC (6084)

**Job Function**
Regulatory Affairs

**Requisition ID**
2206055926W

  • Assoc. Director Global Labeling Product Leader

    vor 2 Wochen

    Bern, Schweiz Johnson & Johnson Family of Companies Vollzeit

    Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ or other locations may be considered (Titusville, NJ, Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland Allschwil,...

  • Global Labeling Associate/ Global Regulatory

    vor 7 Monaten

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Global Labeling Associate

    vor 7 Monaten

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Associate Director, Bio Process Science Lead

    Vor 5 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    As a Associate Director, Bio Process Science, you are a member of the global team of process science experts within R&D, Plasma product development department, responsible for the manufacturing process for plasma derived therapeutics. You will act as the global product lead and senior scientific expert for a defined CSL product portfolio. In this role, you...

  • Associate Director, R&d Project Management

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Position Overview** As a key member on Product Strategy Teams, the Associate Director Project Management is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body drive scenario planning...

  • Associate Director, Global Feasibility

    vor 5 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    The **Associate Director, Global Feasibility,** is the strategic interface with Clinical Development and Clinical Portfolio Execution to provide quality-by-design/strategic insight on protocol and country early feasibility and build allocation strategy scenarios in line with budget. The role is also the primary interface with the Global Medical Affairs and...

  • Global Product Leader

    Vor 5 Tagen

    Bern, Schweiz CSL Plasma Vollzeit

    The Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...

  • Associate Director, Global Lead Performance

    vor 7 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    As the responsible for Global Procurement information, savings and reporting function, you are accountable for building, maintaining and developing the project management, analysis and reporting function within procurement. You will own the transformation plan of the analysis and reporting function, moving from a highly operational and manual process to a...

  • Director Innovation Pharma/consumer

    vor 7 Monaten

    Bern, Schweiz Klöckner Pentaplast Vollzeit

    The Company kp is a globally recognised leader in the packaging and specialty film industry, renowned for its unwavering commitment to sustainability and innovation. The need to act on climate change has never been clearer so we incorporate sustainability into everything we do by #InvestingInBetter - creating innovative products that enhance product...

  • Associate Director, Global Network Supply and

    vor 2 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    The Global Network Supply and Inventory Planner is responsible for global supply, constraint, and inventory planning of CSL’s Products/Value Stream Albumin Products. This role reports to the Global Head, Integrated Business Planning and influentially leads the fractionations/bulk production schedulers located in each site. This role is accountable for...

  • Associate Director Bioprocess Development for

    vor 7 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. With over 1,400 employees we develop and manufacture plasma-derived therapies at our facilities in Bern to deliver them to patients worldwide. For our location in Bern, we are looking for: **Associate Director,** **Bioprocess Development for plasma-de**riv**ed...

  • Cmc Lead Plasma Products Development

    vor 7 Monaten

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest...

  • Director, Epidemiology

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Director, Clinical Epidemiology is responsible for leading epidemiological activities for assigned products across therapeutic areas within Clinical Research & Development to facilitate robust, evidence-based decision making. The role proactively identifies the need for epidemiology evidence, and develops and executes research...

  • Associate Director, Market Access for Inline Assets

    vor 1 Monat

    Bern, Schweiz CSL Behring Vollzeit

    **Role Overview**: The Associate Director of Market Access for Inline Assets will be responsible for implementing market access strategies for CSL Behring inline assets within a specific Therapeutic Area (TA). This role focuses on maximizing the asset's value throughout its life cycle by securing and optimizing product pricing and reimbursement. The position...

  • Senior Computational Research Director for Global Data Science

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    Job OverviewWe are seeking a highly experienced and skilled Senior Computational Research Director to lead our global data science team in developing and applying computational approaches for addressing scientific questions in pre-clinical research and translational medicine.

  • Cmc Lead Plasma Products Development

    vor 7 Monaten

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for...

  • Director, Analytical Strategy Lead

    vor 1 Woche

    Bern, Schweiz CSL Behring Vollzeit

    **The Opportunity**: We are looking for an Analytical Strategy Lead for the newly formed Strategy Office. As Director of Analytical Strategy, you are responsible for aligning the analytical strategy across projects. You will therefore play an essential part in product development. With an advanced understanding of the regulatory landscape of biologics, you...

  • Associate Director/director Business Operations

    vor 7 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    **Associate Director/Director Business Operations** Leading and developing the Business Operations department which provides: E2E material mgmt. incl material planning based on production schedule as well as logistics & warehousing; direct and indirect procurement for the site; Business services resource supply/demand planning and the local Reliability Room...

  • Director, Global Category Lead

    vor 3 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    In this role, you will lead multiple global Category Management teams and you will be responsible for overseeing the development and execution of category management strategies across the entire CSL group to ensure best possible value for CSL while managing risk and maintaining compliance in procurement practices. You will be directly involved in major...

  • Senior Director Regulatory Group Lead

    vor 4 Wochen

    Bern, Schweiz CSL Plasma Vollzeit

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...