Analyst II Document Publishing HyderabadBangaloreMumbai

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Bangalore Karnataka India Hyderabad Andhra Pradesh India Mumbai Maharashtra India

Job Description:

Analyst II Document Publishing - Hyderabad/Bangalore/Mumbai

Position Summary:

• Supports the technical aspects of document production for the authoring community. Primary focus is on activities with both short-term (1-2 years) and long-term (3 years) horizons.

• Must communicate closely with the authoring community other departments and vendors.

• Works independently and mentors Document Specialists.

• Requires strong interpersonal skills with a service-oriented attitude and ability to interact effectively with all levels of the organization in an inter-disciplinary environment.

• Makes decisions with limited guidance: recognizing how to best interpret and coordinate department specific standard operating procedures work practices and health authority guidance on preparing electronic submissions; and decisions that support the resolution of troubleshooting issues.

• Follows established document processing procedures and standards.

• Overall priorities are guided by the supervisor with incumbent exercising a moderate level of autonomy and judgment on daily work assignments and priorities within the context of the document publishing process.

• Ability to resolve moderate-to-complex document processing-related issues for assigned documents in collaboration with colleagues and/or supervisor as needed.

• May have additional major responsibility with supervision
• Ability to use AI and digital tools to support day-to-day tasks and current processes improve efficiency and comply with company policies on data privacy security and disclosure.

Principal Responsibilities:

• Includes but not limited to the creation of submission documents (individual documents and compound documents).

• Meets internal document standards regarding formatting timeliness and submission readiness with minimum guidance.

• Provides advanced publishing services of complex documents using industry standard publishing tools including submission ready formatting hyper-linking and bookmarking.

• Provides document management services including electronic document secure storage in the submissions document repository indexing and archiving of approved documents in accordance with quality standards.

• Performs technical QC of Word PDF and complex files.

• Participates in testing and validation of new publishing and document management software releases and tools.

• Provides technical guidance to document authors in producing e-submission ready documents.

• Assists with training for new processes or software as appropriate.

• Learns and adheres to SOPs templates best practices and policies.

• Regularly meets with manager and mentors and attends departmental meetings.

• Completes all training and time-reporting as required in relevant company systems.

• May mentor more junior staff on document processing procedures or provide peer review.

Principal Relationships:

• Internal (as collaborator and peer): manager other document specialists cross-functional contacts (eg clinical regulatory transparency team 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 close supervision.

Education and Experience Requirements:

• 4-6 years of experience in document processing activities preferably with pharmaceutical industry experience.

• Proficient word-processing skills - using industry standard software.

• Ability to handle multiple projects.

• Solid organizational interpersonal and written/oral communication experience.

• Demonstrated mastery of electronic document publishing and electronic document management systems.

Other:

• In-depth knowledge of publishing software electronic document management systems and intra- and inter-document linking.

• Strong word-processing skills and proficiency with MS Office and Word templates Adobe Acrobat and other relevant tools.

• Knowledge of templates and complex document formats.

• In-depth understanding of the document-level processes and guidelines that impact those processes.

• Effective interpersonal teamwork and communication skills.

• Ability to work or lead in a matrix environment and influence stakeholders.

• Knowledge of Regulatory Information Systems Veeva publishing tools project management and tracking tools.

• Knowledge and skills to build productive relationships across the organization and with external stakeholders.

• Demonstrated problem solving troubleshooting and adaptability.

• Proficiency in submission-related HA and Industry regulations and guidelines as relevant.

Required Skills:

Preferred Skills:

Analytical Reasoning Brand Research Business Behavior Design Thinking Detail-Oriented Industry Analysis Market Research Package and Labeling Regulations Problem Solving Process Oriented Product Packaging Design Project Management Project Support Proof Reading Software Quality Assurance (QA) Regulatory Affairs Management Regulatory Compliance Risk Assessments Safety-Oriented