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Document Specialist, Translational Oncology and Clinical Reporting

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Document Specialist, Translational Oncology and Clinical Reporting will be integrated within the Translational Oncology & Clinical Reporting team of scientists, medical reporting curators, scientific copy editors, and project managers, to carry out organizational and operational tasks in support of Foundation Medicine’s medical reporting development and processes.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

Key Responsibilities

• Support writing and process of QA documents, such as non-conformance reports (NCRs), standard operating procedures (SOPs), continuing education documentation etc.

• Manage processes.

• Perform routine activities as specified in a process document or SOPs.

• Assist in drafting change control forms for international and domestic product updates.

• Document and maintain product requirements in cross-functional shared spaces.

• Track project updates and major milestones using Smartsheets and other software.

• Provide support for design-related updates, such as removing Protected Health Information (PHI) and making PDF adjustments as needed.

• Summarize and track software release packages.

• Record and distribute meeting minutes and action items to key stakeholders.

• Represent FMI to an external audience or partnership.

• Maintain availability to work outside of a regularly scheduled shift.

• Other projects as periodically assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree

Preferred Qualifications

• 1+ years of experience in a scientific field

• Experience with QA or Regulatory documents

• Experience with Atlassian software (such as Jira and Confluence)

• Ability to perform careful, detail-oriented work under deadline pressure

• Ability to deliver high quality documentation on time while paying attention to details

• Ability to manage and prioritize multiple tasks

• Ability to quickly grasp and adapt to complex, changing systems

• Ability to perform assignments with minimal supervision

• Ability to collaborate with colleagues across departments to quickly resolve questions or technical issues

• Superior verbal and written communication skills

• Strong organizational, administrative, and analytical skills

• Creativity and problem solving skills

• A desire to learn and develop

• Understanding of HIPAA and importance of privacy of patient data

• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion

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Internal applicants, please use your FMI email address.

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