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Document Management Specialist

2+ years
$90K/yr - $96K/yr
12 June 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

About the job

The GDM Coordinator will drive enhancement of the GDM function by working closely with the Global GxP Document Management (GDM) Leads and Global Standard Operating Procedure (GSOP) Administrators on various initiatives and workstreams. As this is a dynamic role, the ideal candidate should be comfortable performing a wide variety of daily tasks, and quickly be able to adjust their strategies to match the business need. The GDM Coordinator will engage with different units of Global Quality and functional areas as assigned, driving the success and continuous improvement of GDM goals and initiatives, as well as the following tasks:

• Perform delegated tasks, specifically as a backup for the GSOP Administrator, related to GxP procedural and governance document management as defined in the GSOP covering this activity.

• Support the management of GDM initiatives and team meetings, manage teams and channels in MS Teams.

• Develop agendas and communicate meeting outcomes.

• Ensure project plans are implemented in accordance with timelines and any issues, challenges, or deviations are escalated for resolution in a timely manner.

• Prepare management presentations for meetings and forums.

 

Education and Experience:

• Minimum of a bachelor’s degree, preferably in a life science-related field

• 2+ years of experience in the use of an electronic document management system, preferably in a GxP environment

• Technical writing experience

• Excellent communication skills, i.e., colloquial and correspondence skills, as well as be able to adjust effectively within an international team

• Advanced Microsoft Office Suite skills, including proficiency in PowerPoint and MS Teams, required

• Experience with Visio, Monday.com, or SharePoint is a plus

• Interface with senior management on various projects and initiatives as needed

• Team player with the ability to work effectively in a multi-cultural, multifaceted corporate environment across different time zones

• Able to adapt and work administratively in a technical environment

• Ability to work with attention to detail while maintaining a high level of accuracy

 

Term & Start

  • 12+ month contract with the possibility to extend

  • Must be within driving distance to Princeton, NJ to go onsite 1 time/month

  • Healthcare benefits available

  • 2 weeks to start from offer