Officer Npi/lcm Projects

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopaedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.

As pioneers in our industry, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We create people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

**SECTION 1: JOB SUMMARY**

Lead and deliver strategic and design change projects of Organizational importance.

Lead and Deliver Artwork changes as per customer and regulatory requirement.

Maintain Device Master File (DMF) and related documents.

Support changes in RM, PM and FG Specifications.

Responsible for maintenance of in-house printing area activities, as applicable.

**SECTION 2: DUTIES & RESPONSIBILITIES**

Under limited supervision, general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
**NPI/LCM and Design Change Projects**:
Discuss with marketing and gather end customer requirement in business case.

Get business case approved from relevant stakeholders

Prepare project plan and form project team

Align all the stakeholders on project timelines

Schedule and lead project meetings and send regular updates

Highlight risk of projects and prepare mitigation plan

Lead Design Change Projects

Support in management of Records as per Record retention policies.

**Strategic Projects**:
Prepare project case for critical initiative and get approval from relevant stakeholders

Lead and implement critical initiatives with the help of project team

Prepare stakeholder updates and communication plan

Device Master File (DMF) & Artwork Management:
Development, deployment and maintaining procedures and protocols related to product artwork management as per business requirements and ensure adherence to the same.

Lead and/or support NPI/LCM Projects and initiatives while implementing the artwork changes and document the same on time in the business systems

Cater to tender business-relate artwork changes and requirements.

Maintain Device Master File (DMF), Product label (artwork) and leaflet repository.

Ensure self-training and train others on functional procedures and protocols.

Direct and guide product label graphics and artwork agency to deliver required artwork flawlessly and on time and within cost budgets.

Ensure compliance adherence with respect to company policies and regulatory requirement.

**NPI/LCM Specification Management**:
Support in Raw Material (RM), Packaging Material (PM) and Finish Goods (FG) specifications management which includes Creation of New Spec, Change in Spec, Alignment of Spec with Franchise Spec, Phasing out of Specs for Product Family for India Sites

**Printing Area Responsibilities**:
Monthly signoff on - Hazard Waste transfer note, Contractor personal gate pass & Building Ownership Checklist Form (whereas required)

Management of supplier contract extension annually in JJEDS.

**General Responsibilities**:
Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

**Qualifications**:
**SECTION 3: EXPERIENCE AND EDUCATION**

Graduate/post graduate in Engineering/Pharmacy.

A relevant advanced degree is preferred.

A total of 3 - 5 years of work experience is encouraged. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.

Demonstrated knowledge of manufacturing principles and practices, and procedures

Ability to communicate effectively with a diverse clientele base

Ability to work collaboratively with coworkers and the public

**SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and A