J&J Family of Companies is hiring: Associate Director, Document Publishing in Ti

J&J Family of Companies - Associate Director, Document Publishing

Titusville, New Jersey

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:

1. Manage assigned Therapeutic Area and/or Business deliverables.
2. Oversee DPS staff, ensuring high-quality deliverables and compliance with industry standards.
3. Accountable for the quality of deliverables and compliance of direct reports and approves any critical decisions.
4. Lead performance management and succession planning efforts for direct reports.
5. Actively participate in resource management and hiring decisions.
6. Contribute to setting the overall strategic vision of the DPS function.
7. Impact guidelines and standards, resource assessments and assignments, allocation of internal and external resources, and recommendations for global sourcing strategies.
8. Work independently and as a member of a team when making recommendations and decisions.
9. Make recommendations and decisions that influence the overall strategic vision of the DPS function.
10. Accountable for recommendations and decisions that have both a short-term (1-2 years) and long-term (3+ years) focus.
11. Contribute to the research and development of new technologies and process innovations that will increase the efficiency of document publishing.
12. Participate in cross-pharma initiatives that support the document preparation process.
13. Take a leadership role in representing the needs of functional areas in the implementation and maintenance of the document management system.
14. Make recommendations and decisions that impact internal processes, guidelines and standards, global technology systems, and the interpretation of submission requirements regarding documents.
15. Balance the needs of customers with those of the upstream and downstream contributors/customers in cross-functional teams.
16. Oversee the development and maintenance of processes and procedures for document preparation, review, and approval.
17. Ensure adherence of documents to all quality and submission standards.
18. Partner effectively with cross-pharma R&D groups.
19. Participate in the annual budget setting process for DPS function.
20. Participate in vendor and flex partner activities.
21. Work collaboratively with cross-functional teams to support proper development of electronic publishing practices.
22. Complete all training and time-reporting as required in relevant company systems.
23. Participate in initiatives, as applicable.
24. Directly contribute to metrics and KPI standards.
25. Serve as knowledge base for technical and style-related issues.
26. Communicate updates and other critical information to the DPS user community.
27. 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 are 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.

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

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