Associate Director, Document Publishing

Job Description - Associate Director, Document Publishing (2406222997W)

Associate Director, Document Publishing - 2406222997W

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.

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.
• Makes recommendations and decisions that influence the overall strategic vision of the DPS function and the processing of documents.
• 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.
• Makes recommendations and decisions that impact internal processes, guidelines and standards, global technology systems, and the interpretation of submission requirements regarding documents.
• Balances the needs of customers with those of the upstream and downstream contributors/customers in cross-functional teams.
• Oversees the development and maintenance of processes and procedures for document preparation, review, and approval.
• Ensures the 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 and ensure cohesive and coordinated approaches are maintained.
• 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.
• Participates in vendor and flex partner activities, such as annual purchase order preparation, onboarding/offboarding, billing, quality assessment, and operational oversight meetings.
• Works collaboratively with cross-functional teams to support proper development of electronic publishing practices, including evaluation and adoption of new technologies.
• Completes all training and time-reporting as required in relevant company systems.
• Participates in initiatives, as applicable.
• May have additional major responsibility with minimal supervision:
• Partnering across functional areas and business operations team to manage department forecasting, demand, supply, and system time entry standards.
• Directly contribute to metrics and KPI standards.
• Serve as knowledge base for technical and style-related issues, processes, and regulatory submission requirements for clinical customers.
• Take a proactive role on cross-functional/cross-pharma project teams as needed, representing the Clinical perspective, and promoting understanding of the end-to-end process flow, upstream and downstream effects, and consistency across projects.
• Communicate updates and other critical information to the DPS user community.
• 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 and the ability to seek out new appropriate technologies 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.
• Proactively identifies potential risks and develops strategies to mitigate is preferred.
• Ability to build and maintain solid and productive relationships with cross-functional team members is required.
• Ability to act as change agent and adapt to rapidly changing organizational & business challenges 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.

The anticipated base pay range for this position is 120000 to 207000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Primary Location Other Locations Organization Job Function Job FunctionRegulatory Product Submissions and Registration #J-18808-Ljbffr

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