Job Description

Johnson & Johnson Medical Devices Companies is recruiting for a Senior Medical Writer, Distiller Specialist located in Warsaw, IN, United Kingdom, Philippines or Armenia. Remote work options may be considered on a case-by-case basis and if approved by the Company. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. The Senior Medical Writer/Distiller Specialist manages the design, maintenance and quality of the Distiller database for medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), PMA FDA Reports, and State of the Art (SOA) Reviews for assigned therapeutic areas within Johnson & Johnson Global Medical Device (HMD) businesses within his/her scope of responsibility. The Senior Medical Writer/Distiller Specialist demonstrates knowledge of the therapeutic areas and incorporates project specific strategic direction based on product Instructions for Use and the systematic literature protocol and will ensure the execution of credible deliverables to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices. The Senior Medical Writer/Distiller Specialist collaborates with other Medical Affairs and Operations Team members including Medical Writing Managers, Senior Medical Writers, and Medical Writers as applicable as well as cross functional teams such as the Complaints Handling Unit and Technical Writing.

Key Responsibilities:

• Leads the development and implementation of effectively designed data collection forms for clinical data from published articles on J&J medical devices and similar devices using a software by Evidence Partners, Inc (Distiller).
• Configures new projects in Distiller through the data collection form, workflow, other settings and ensures alignment with the systematic literature protocol.
• Incorporates output from literature searches into the Distiller database.
• Programs, builds and maintains project-specific screening and extraction form templates across all therapeutic areas.
• With the Senior Medical Writer or Medical Writing Manager performs quality checks of newly built or edited screening and extraction Distiller project-specific forms to ensure performance meets expectations.
• Maintains consistency across Distiller projects to enable cross-project reporting and merging of data.
• Facilitates the organization and prioritization of Distiller project form building.
• Manages user access and associated quarterly reviews.
• Designs reports and pulls metrics using Distiller datarama feature.
• Manages and delivers the Distiller training program for Medical Writing Managers, Medical Writers and/or Medical Information Specialists.
• Liaison with Evidence Partners, the Distiller software company
• Performs quality reviews of standard variable names and provides variable listing sheets to writers upon request.
• Collaborates with Distiller users to troubleshoot issues.
• Assists with other medical writing tasks as needed.

Qualifications
Education:

• BA, BS, or BSN is required with 5 years of related experience, Master’s with 3 years relevant experience, or PhD with 2 years relevant experience is required.

Experience and Skills:

Required:

• Understanding of good data management practices is required.
• Experience using software systems (e.g. Microsoft Excel, Medidata Rave) to manage data is required.

Preferred:

• Knowledgeable in clinical data management, database design (e.g. Electronic Data Capture Systems [EDC] such as Medidata Rave or Systemic Literature Review software such as Distiller) and/or Biostatistics is preferred.
• Experience within the medical device industry is preferred.
• Knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is preferred.
• Demonstrated knowledge and experience in clinical research, data collection and organization, quality regulatory compliance, adverse event reporting is preferred.
• Knowledge of bibliographic software (e.g. Endnote, Reference Manager) is preferred.

Other:

• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. The base pay range for this position is $101,500 to $142,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits

Primary Location
United States-Indiana-Warsaw-700 Orthopaedic Drive
Other Locations
Europe/Middle East/Africa-United Kingdom, Asia Pacific-Philippines, Europe/Middle East/Africa-Armenia
Organization
Medical Device Business Services, Inc (6029)
Job Function
R&D
Requisition ID
2206044059W