J&J Family of Companies Associate Director, CMC Business Liaison in Spring House, Pennsylvania
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an Associate Director, CMC Business Liaison within the Regulatory Submission Management & Operations Group. This position may be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Malvern, PA, Beerse, Belgium; Leiden, Netherlands; or High Wycombe, England.
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, Business Liaison manages one or more Communities of Practice (CoP) within RSMO for a specified focus / service business area (primarily CMC). This position works with the RSMO Management Team, RSMO Business Liaisons, business area stakeholders and other RSMO and/or cross-functional and sector colleagues (as needed) to develop and implement a Strategic Plan. The plan includes RSMO’s core capabilities, strategic partnerships, value added services, competitive positioning, internal/ external delivery channels, and new and emerging opportunities relevant to a full, global support model. This position ensures alignment of activities and standards across CoPs and TAs.
Impact (Outcomes) of Decision-Making
Collaborates with senior leadership, members of the CoP, other Business Liaisons, cross-function, and sector and business partners.
This position makes decisions regarding departmental guidelines, templates, standards, processes, and resourcing working with other Business Liaisons across CoPs.
This position makes decisions that impact the strategic/tactical planning, timeliness, and quality of submissions.
Accountability for Decision-Making
Accountabilities include driving processes, standards, and technology solutions to be applied and utilized in order to consistently produce high quality output.
This position leads and directs efforts with internal and external partners.
This position partners with other colleagues within and outside their CoPs to ensure deliverables are effective, consistent across TAs, and are of value.
This position supports and maintains the strategic direction established by the RSMO Management Team.
Mastery of regulatory affairs and submission requirements knowledge and understanding of where to get the information.
Understanding of product development process.
General knowledge and understanding of Document Management Systems.
Effective interpersonal, teamwork, and communication skills.
Ensures applications of lean business and process excellence approaches to ensure effectiveness and continuous improvement including knowledge management (subject matter intelligence, “lessons learned”), analytical problem solving, and process analyses/development.
Collaborates with leadership and colleagues to develop and maintain scope, strategy, and milestones including support of process and dashboard development opportunities.
Oversees/leads the development, implementation, monitoring, and ongoing evaluation of departmental processes, standards and practices (e.g., SOPs, work instructions, etc.).
Drives, supports, and/or aligns with internal and external innovation initiatives to enhance capabilities / processes to drive development / evolution of standardized business practices.
Consistently delivers services/direction commensurate with business requirements and priorities, including establishing on-going team communications to identify and resolve issues and to assess quality, delivery, and effectiveness.
Oversees and supports audit and inspection activities, if required.
Provides leadership for the CoP team and captures metrics, as required. Measures and maintains compliance.
Liaises with key stakeholders, partners, customers, cross-functional and cross-sector SMEs identifying and differentiating high value opportunities relative to scope and RSMO business within and across relevant functional areas/units (e.g., GRA, Janssen, and other J&J functional areas / companies / sectors as appropriate).
Conducts initial customer needs assessment, including requirements, external drivers (e.g., HAs), time lines, resource requirements, costs and benefits; develops recommendations for RSMO Management Team. Translates customer needs into tailored RSMO services that leverage global capabilities.
A minimum of a Bachelor’s Degree required
A minimum of 6-8 years of relevant/related professional experience required with Bachelor’s Degree. Masters/PharmD/PhD with 4-6 years’ experience is preferred
A minimum of 5 years of Regulatory Affairs experience preferred
In-depth understanding of drug development process is highly preferred
Demonstrated project or submission management capabilities is highly preferred
Demonstrated effective interpersonal, teamwork, and communication skills required
Ability to exercise solid judgment and communicate effectively with varied levels of the organization required
Ability to work or lead in a matrix environment required
Demonstrated ability to build productive relationships and influence stakeholders across an organization required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan
United States-Pennsylvania-Horsham, United States-New Jersey-Titusville, United States-Pennsylvania-Malvern, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden
Janssen Research & Development, LLC. (6084)