Biotech and Agricultural Management & Business Others Medical and Healthcare
6 - 10 Years
Associate Director, Process Management
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Process Management within the GRA (Global Regulatory Affairs) Business Enablement Organization. The position can be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA); Canada (Toronto, Ontario); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); or remote (in NA, LATAM or EMEA) for the right candidate.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Associate Director, Process Management takes a global leadership role for driving the optimization of the process knowledge management, procedural document and training approach within Janssen GRA. The role ensures high quality processes/procedural documents in line with regulatory requirements/compliance standards. The role ensures that messaging to training audiences is effective, meaningful, insights-driven and deployed in a timely manner. The role drives innovation in alignment with appropriate groups within Janssen, and identifies opportunities for optimization, remediation, innovation, and/or standardization across GRA. This role takes a leadership role in representing GRA externally across the enterprise from a process and training perspective.
In this role, you will:
Develop and deliver on strategy for process and procedural documents management across GRA and externally to GRA.
Provide input to the development of global and regional training programs.
Provide input to other quality management partners and harmonizes within/across organization.
Proactively translate processes, knowledge, expertise and learnings obtained from cross-company opportunities into recommendations on opportunities to evolve and improve process management to better address needs aligned with business objectives.
Guide GRA in the creation, development and maintenance of processes and procedures deployed across the GRA community.
Drive, manage, and oversee improvement projects that foster innovative ideas.
Partner with subject matter experts to better understand needs and develop solutions through new or improved processes.
Develop and lead innovative initiatives to improve business performance.
Uncover key insight and barriers along the process management journey to identify new ways to improve the training and knowledge management experience.
Utilize storytelling (audience understanding, effective messaging, and meaningful delivery) to develop insights-driven messaging for communications to GRA.
Oversee compliance training to ensure inspection readiness across GRA.
Ensure implementation of new digital solutions and processes to ensure efficiency gains and to support business continuity.
Ensure the integration of appropriate risk management with current and emerging processes.
Represent GRA in appropriate committees and projects.
A minimum of Bachelor’s degree (or equivalent) in a scientific or business discipline is required.
An advanced degree (MS, PhD, MD or PharmD) is highly desired.
At least 8 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
Demonstrated ability to resolve conflict, influence teams, and to build relationships in meeting organizational objectives, without formal authority required.
Knowledge of managing aspects of Quality Management or Regulatory Compliance in an international, global context, or in in a regulated healthcare environment highly preferred.
Proven track record of effective communication skills is required.
Regulatory experience and understanding of interactions with health authorities (e.g., FDA, EMA, or MHRA). Knowledge of what the pertinent regulations cover, how they're applied, and what their implications are is preferred.
Experience leading teams within a matrix environment to establish and achieve shared goals in a high pressure, time sensitive environment is preferred.
This position can be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), Canada (Toronto, Ontario), UK (High Wycombe), Netherlands (Leiden), or Belgium (Beerse); or remote for the right candidate (in NA, LATAM or EMEA) and may require up to 10% domestic and international travel.
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.
United Kingdom-England-High Wycombe- Other Locations
North America, Latin America, Europe/Middle East/Africa, North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse Organization
Janssen Cilag Ltd. (7360) Job Function
Regulatory Affairs Requisition ID
Open Positions from Johnson & Johnson Family of Companies