Manager, RA Submissions

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Manager, Clinical Trial Applications Submissions Management,

Johnson & Johnson is recruiting for a Manager RA Submissions. This hybrid work position will be located in Allschwil, CH, Leiden NL, Warsaw, PL. The position will manage Clinical Trial Applications as a member of the Next Generation Submissions (NGS) organization.

Key Responsibilities:

• Be responsible for the operational management and delivery of global clinical trial regulatory submissions.

• Create and handle dossier plans/submission packages in line with clinical trial regulatory strategy,

• Support decision making impacting the quality and timeliness of Clinical Trial Health Authority submissions

• Make decisions on clinical trial submission operational strategies for the best project management approach within process/timeline/resource constraints.

• Lead Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.

• Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.

• Cultivate effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.

• Develop departmental work practices, process enhancements / improvements, and associated training materials

• May be responsible for performance and development of direct reports.

Qualifications, Experience and Skills:

• University/bachelor’s degree and 6 years of related professional experience, or

• Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience

• In-depth understanding of drug development process

• Ability to demonstrate in-depth knowledge of clinical trials regulatory submissions, filings, and processes

• Ability to work and lead in a matrix environment

• Proven ability to build positive relationships and influence stakeholders across an organization

• Proficiency in relevant clinical trials submission-related Health Authority and Industry regulations and guidelines

• Proficient use of Regulatory Information Systems

• Fluency in English; other languages may be required depending on assignment.

• Project / submission management proficiencies

• Previous experience leading Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of submissions and filings

Other

• May lead and/or contribute to special projects and participate in process improvement initiatives.

• May require up to 5% travel, domestic and international.