Experienced Analyst, Marketing Operations-IFU

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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We are searching for the best talent for Experienced Analyst Marketing Operations-IFU.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: As Abiomed expands its product set and global business there is a need to increase standardization of processes and capacity to manage changes in technical documentation including Instructions for Use (IFUs). This role will play an integral part in developing consistent project management practices for IFU releases and Experience Analyst Marketing Operations for IFU will be part of the Marketing Operations Management team overseeing IFUs and be primarily responsible for managing the intake of project requests supporting Product Managers and project originators to drive and track their projects and managing the production workflow and tasks. This role will interface with multiple functions across the organization including Product Management Engineering Quality Regulatory Labeling and more to ensure alignment to standards and operating procedures and facilitate prioritization and decision-making where needed.

The right candidate is curious fearless and dedicated to improving patient outcomes. A detail-oriented individual with big picture aspirations will find satisfaction with orchestrating this global operation of technical documentation.

You will be responsible for:

Overall:

• Drives consistency and efficiency of processes and ensures continuous improvement

• Accountable for ensuring IFU changes align to project timelines and Quality systems

• Leads overall orchestration and prioritization of IFU projects

• Maintains oversight of IFU production backlog including driving execution of production tasks and ensuring status of projects and activities is accurate and current

• Facilitates cross-functional and cross-platform IFU projects communications and governance

IFU Projects

• Ensures all requests follow standard processes and contain required information

• Facilitates communication between project originators Product Managers labeling experts and any other parties to clarify requirements

• Maintains tracking of new in-flight and released projects in Roadmunk tool

• Provides reporting on project status including risks and actions needed escalating appropriately as needed

• Works with various Project Teams to align on priorities including balancing potentially competing business objectives

• Creates and coordinates production tasks driving accountability for timely and accurate execution

• May manage change request and release process for select IFU projects

• As needed performs Quality Control (QC) proofreading review once requested changes have been incorporated

• Engages with translation vendor ensuring timely and accurate delivery of certified translations

• Maintains project backlog and contributes to defining execution strategy

Operations

• Hosts regular strategy and project review meetings and facilitates executive communication

• Supports internal operations goals including system and process improvement strategic initiatives stakeholder enablement SharePoint site maintenance etc.

• Drives continuous improvement in systems process and communications

Qualifications/Requirements:

• Bachelors degree required

• Minimum 2 years of project management experience within a regulated environment (e.g. medical devices quality or regulatory) preferably in MedTech or a similar industry.

• Proficiency in Microsoft Office365 Adobe Acrobat

• Experience with Project Management tools (e.g. Smartsheet Roadmunk or similar)

• Strong communication and collaboration skills

• Strong skills in project governance status reporting and risk/issue management

• Tolerance and flexibility within a fast-paced environment

• Experience coordinating diverse cross-functional teams

• Attention to detail including review of written materials

• Strong understanding of technical documentation regulatory compliance and other product lifecycle requirements

• Strong understanding of labeling technical documentation regulatory compliance and other product lifecycle requirements preferred; relevant experience could include Quality Systems Document Control Operations Sr. Tech Writers Process Owners/Engineers

• Limited travel required (less than 10%).

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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Senior IC