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MDR - Project Coordinator II

Lafayette, CO 80026

Posted: 10/07/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614942 Is job remote?: No Country: United States

Job Description


Top 3 things the manager is looking for in a candidates experience:
  1. Attention to detail
  2. Program/project management experience
  3. Tech Comm or labeling experience

Top 3 Tasks or Responsibilities in scope for this role:
  1. Manage and input metadata for eManuals publishing on company website.
  2. Cross-functional collaboration to support eManuals activities and accuracy of data
  3. Create best practices and process improvements to eManuals activities.

Education Required: Medical device experience preferred if no Bachelor’s degree.

Years’ Experience Required: 2+ years

Do they need to be local to any MDT office? Yes -  Minneapolis, MN, North Haven, CT, or Lafayette, CO regions.

Does this person need to be on site?  1x/week or more.

If yes – what days? What core hours? Wednesdays

 
TECHNICAL SKILLS
Must Have
  • Bachelor’s degree with 2+ years of job-related experience
  • Master’s degree with 6+ months of job-related experience

Nice To Have
  • Demonstrated ability to work independently and with a team.
  • Demonstrated proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
  • Experience working in a medical device environment.
  • Experience working in a regulated environment.
  • Experience working with FDA, ISO, EN, and/or GMP standards.
  • Proven ability to easily adapt to and master proprietary programs.
  • Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.
  • Proven, strong detail-oriented work skills.

Responsibilities may include the following and other duties may be assigned. Provides project or program support to a functional group or business process. Monitors program/project/system status, budgets and timetables. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding.
  • Configuration Management:
    • Coordinates with Product Release and Configuration Assurance to prepare and route Engineering Change Orders and Change Actions (CO/CAs).
    • Fulfill internal customer requests for electronic versions of labeling.
    • Review parts prior to CO/CA release to ensure that all requirements for end item components and specifications are met, escalating issues as necessary.
    • Create and maintain end items in a product lifecycle management (PLM) system.
  • Quality System:
    • Coordinate with Product Release and Quality Systems to prepare and route product design documentation.
    • Perform change control audits of labeling and packaging components.
    • Perform proofs of labeling components and print vendor labeling.
    • Ensure personal understanding of all quality policy/system items that are applicable.
    • Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • eManuals Release:
    • Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.
    • Coordinate activities surrounding the qualification and release of eManuals for product launches.
    • Participate in user acceptance testing for the eManuals website as needed.
    • Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.
    • Participate in requirements definition and testing for new features on the eManuals website.
    • Work closely with internal and external partners to assist in troubleshooting problems with content, quality, or schedule and negotiate resolution of issues.

OFFICE SUPPORT CAREER STREAM: Individual contributors who provide organizational related support or service (administrative or clerical) for other members within the organization. The majority of time is spent in the delivery of support services or activities, typically under supervision.

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works on clerical and administrative assignments that may require application of prior experience. Works under moderate supervision, making minor adjustments to methods and processes. Organizational Impact: Works to deliver on daytoday objectives with direct impact on achievement of results for the job area, including moderate scheduling or customer satisfaction implications. Work consists of tasks that are typically routine, with some deviation from standard practice .

Innovation and Complexity: Checks and makes minor adjustments to work methods to solve problems that are routine and typically exist in current work processes and systems. May be required to highlight areas of concerns/problems and puts forth solutions in own job area. Communication and Influence: Communicates typically with internal contacts within and outside of immediate team. Obtains and provides information requiring some explanation or interpretation .

Required Knowledge and Experience: Requires full job knowledge of systems and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Lafayette, CO

Ready to take your career to new heights? Explore job opportunities in the vibrant area surrounding Lafayette, Colorado! Located in Boulder County just a stone's throw away from Denver, Lafayette boasts a perfect blend of small-town charm and big city amenities. With a thriving arts scene, including galleries like The Collective Community Arts Center and performances at the Mary Miller Theater, as well as easy access to outdoor adventures at Waneka Lake Park and Indian Peaks Wilderness, this area offers a unique mix of culture and natural beauty. Join our team and discover why Lafayette, CO is the perfect place to grow both personally and professionally. Start your job search today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.