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Program Documentation Specialist I

3+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Program Management Support - Electronic Design History Files (eDHF)

Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office


About the Company

Thermo Fisher Scientific Inc. is a global leader in serving science, with revenues over $40 billion and a workforce of approximately 130,000 employees. We provide support across life sciences research, analytical challenges, patient diagnostics, and the development of life-saving medicines. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services – we offer innovative technologies and services to enhance laboratory productivity and deliver customer solutions.


Position Summary

This role supports the divisional program management team by ensuring the proper completion, organization, and approval of electronic design history files (eDHFs) during new product development.


Key Responsibilities

  • Support for Program Managers: Assist in preparing and submitting documents into OCPLM PPM via Change Orders (COs).

  • Document Review: Ensure that program-specific information is consistent across all documents.

  • Compliance: Verify that all program documents contain the correct project number and comply with existing procedures and corporate standards.

  • Adherence to SOPs: Ensure compliance with site-level and corporate SOPs or Work Instructions to align with ISO standards.

  • Document Uploading: Upload documents into the system, ensuring proper document linking and approvals are in place.

  • Change Order Tracking: Follow up with relevant stakeholders to confirm timely processing of COs.

  • Program Status Communication: Regularly track and communicate CO status updates to program managers.

  • Organize eDHFs: Ensure all eDHFs are organized clearly and in line with quality standards.


Preferred Minimum Requirements/Qualifications

  • Education: Bachelor’s degree from an accredited college/university.

  • Collaboration: Ability to work effectively with global teams and establish positive internal relationships.

  • Document Management Systems: Experience with document change control systems such as Agile PPM and Documentum.

  • Communication Skills: Strong verbal and written communication skills, with the ability to address issues effectively.

  • Independence: Capable of working independently with established procedures.

  • Organizational Skills: Diligent, detail-oriented, and organized.

  • Software Proficiency: Proficient in Microsoft Office 365 suite and Agile.


Thermo Fisher Scientific is an EEO/Affirmative Action Employer, providing equal opportunity for all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other legally protected status.