Description:
Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Document Publishing. This position can be located in the US (Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ); Beerse, Belgium; High Wycombe, United Kingdom; and Allschwill, Switzerland. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. The Associate Director drives decisions impacting document processing, establishes guidelines and standards, oversees resource allocation, and leads cross-functional initiatives to improve efficiency and compliance in regulatory submissions. A leadership role contributing to shaping the strategic direction of the Document Publishing Solutions (DPS) function. Position Summary: Manage assigned Therapeutic Area and/or Business deliverables. Oversee DPS staff, ensuring high-quality deliverables and compliance with industry standards. Oversight of personnel within DPS in the processing of documents using established guidelines. Accountable for the quality of deliverables and compliance of direct reports and approves any critical decisions. Lead performance management and succession planning efforts for direct reports. Actively participates in resource management and hiring decisions. Contributes to setting the overall strategic vision of the DPS function. Impacts guidelines and standards, resource assessments and assignments, allocation of internal and external resources, and recommendations for global sourcing strategies. Works independently and as a member of a team when making recommendations and decisions. Accountable for recommendations and decisions that have both a short-term (1-2 years) and long-term (3+ years) focus. May have additional major responsibility with minimal supervision: Contributes to the research and development of new technologies and process innovations that will increase the efficiency of document publishing. Participates in cross-pharma initiatives that support the document preparation process. Takes a leadership role in representing the needs of functional areas in the implementation and maintenance of the document management system. Balances the needs of customers with those of the upstream and downstream contributors/customers in cross-functional teams. Principal Responsibilities: Oversees the development and maintenance of processes and procedures for document preparation, review, and approval. Ensures adherence of documents to all quality and submission standards. Partners effectively with cross-pharma R&D groups, such as Regulatory Operations, Information Technology, and other functions, in providing support and process improvements to maximize operational efficiency. Participates in the annual budget setting process for DPS function, and proactively manages resource planning and allocation of individuals to meet the portfolio objectives throughout the year. Works collaboratively with cross-functional teams to support proper development of electronic publishing practices, including evaluation and adoption of new technologies. May oversee the work of others without a direct reporting relationship. Qualifications: BS/BA degree and 7-10 years’ experience in technical and document processing activities associated with regulatory submissions in the pharmaceutical industry. Individuals without a degree may be considered with 12-14 years of relevant pharmaceutical/scientific experience. At least 2 years of people management experience is required. Experience managing external providers is required. In-depth knowledge of industry standards and internal submission standards for documents used in health authority submissions is required. Advanced working knowledge of publishing software, electronic document management systems, e-submission requirements, Microsoft Word and template functionality is required. Effective interpersonal, teamwork, and communication skills is required. Ability to work or lead in a matrix environment and influence stakeholders is preferred. Demonstrated problem solving, troubleshooting, and adaptability is required. Ability to build and maintain solid and productive relationships with cross-functional team members is 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.
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Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Document Publishing. This position can be located in the US (Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ); Beerse, Belgium; High Wycombe, United Kingdom; and Allschwill, Switzerland. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. The Associate Director drives decisions impacting document processing, establishes guidelines and standards, oversees resource allocation, and leads cross-functional initiatives to improve efficiency and compliance in regulatory submissions. A leadership role contributing to shaping the strategic direction of the Document Publishing Solutions (DPS) function. Position Summary: Manage assigned Therapeutic Area and/or Business deliverables. Oversee DPS staff, ensuring high-quality deliverables and compliance with industry standards. Oversight of personnel within DPS in the processing of documents using established guidelines. Accountable for the quality of deliverables and compliance of direct reports and approves any critical decisions. Lead performance management and succession planning efforts for direct reports. Actively participates in resource management and hiring decisions. Contributes to setting the overall strategic vision of the DPS function. Impacts guidelines and standards, resource assessments and assignments, allocation of internal and external resources, and recommendations for global sourcing strategies. Works independently and as a member of a team when making recommendations and decisions. Accountable for recommendations and decisions that have both a short-term (1-2 years) and long-term (3+ years) focus. May have additional major responsibility with minimal supervision: Contributes to the research and development of new technologies and process innovations that will increase the efficiency of document publishing. Participates in cross-pharma initiatives that support the document preparation process. Takes a leadership role in representing the needs of functional areas in the implementation and maintenance of the document management system. Balances the needs of customers with those of the upstream and downstream contributors/customers in cross-functional teams. Principal Responsibilities: Oversees the development and maintenance of processes and procedures for document preparation, review, and approval. Ensures adherence of documents to all quality and submission standards. Partners effectively with cross-pharma R&D groups, such as Regulatory Operations, Information Technology, and other functions, in providing support and process improvements to maximize operational efficiency. Participates in the annual budget setting process for DPS function, and proactively manages resource planning and allocation of individuals to meet the portfolio objectives throughout the year. Works collaboratively with cross-functional teams to support proper development of electronic publishing practices, including evaluation and adoption of new technologies. May oversee the work of others without a direct reporting relationship. Qualifications: BS/BA degree and 7-10 years’ experience in technical and document processing activities associated with regulatory submissions in the pharmaceutical industry. Individuals without a degree may be considered with 12-14 years of relevant pharmaceutical/scientific experience. At least 2 years of people management experience is required. Experience managing external providers is required. In-depth knowledge of industry standards and internal submission standards for documents used in health authority submissions is required. Advanced working knowledge of publishing software, electronic document management systems, e-submission requirements, Microsoft Word and template functionality is required. Effective interpersonal, teamwork, and communication skills is required. Ability to work or lead in a matrix environment and influence stakeholders is preferred. Demonstrated problem solving, troubleshooting, and adaptability is required. Ability to build and maintain solid and productive relationships with cross-functional team members is 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.
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