Job Description

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. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Bangalore, Karnataka, India, Mumbai, Maharashtra, India

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Principal Responsibilities:

Serves as the single point of contact for the authoring community and subject matter expert for delivering submission-ready documents for assigned areas of responsibilities. Coordinates operational aspects of document-level support activities, such as, collaborating closely with authoring community to plan for upcoming support needs, connecting with resources to ensure availability to meet support needs, and resolving any resource gaps. Takes a leadership role for the monitoring and effectiveness of the document-level support processes and initiates changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality. Takes a proactive role on multiple projects with respect to timing, scheduling, tracking, and strategy. Promotes understanding of end-to-end process flow, upstream and downstream effects, and develops consistency across document-level deliverables. Applies appropriate submission standards, requirements, processes, and policies to comply with applicable health agency requirements. Assists with training on new processes or software, as applicable. Assists with external vendor alliance management activities by monitoring quality of deliverables and contributing to vendor work order. Completes all training and time-reporting as required in relevant company systems. Coaches or mentors more junior staff on document processing procedures. Provides peer review as needed. May actively participate in or lead process working groups. May have additional major responsibility with supervision: + Takes a proactive role on multiple projects with respect to timing, scheduling, tracking, and strategy. Promotes understanding of end-to-end process flow, upstream and downstream effects, and develops consistency across document deliverables.


Principal Relationships:

Internal: manager, other document specialists, cross-functional contacts (eg, clinical, regulatory, data management, safety, quality) involved in the planning and preparation of submission documents. External: May interact with or oversee the day-to-day work of contractors or external service providers as needed, under supervision.

Education and Experience Requirements:

BS/BA degree preferred as well as 4 years of experience in document processing activities associated with regulatory submission in the pharmaceutical industry. An Individual without a degree may be considered with 5 to 8 years relevant pharmaceutical experience. Expert word-processing skills - using industry standard software. Strong organizational, interpersonal, and written/oral communication experience. Demonstrated mastery of electronic document publishing and electronic document management systems. Ability to manage multiple projects. * Ability to manage and lead others.