• integrated resources
  • $32,750.00 -47,810.00/year*
  • Woodcliff Lake , NJ
  • Pharmaceutical/Biotechnology
  • Full-Time
  • 8 Dorchester Rd


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Job Title: TMF Specialist - Global Regulatory Operations

Location:?Woodcliff Lake, NJ 07677

Duration- 1 year+ Contract with a good possibility of extension.

JOB DESCRIPTION:

TMF Specialist - Global Regulatory Operations Department.

On-site position - up to 40 hrs week.

?

Roles and Responsibilities:

? Perform daily Trial Master File management activities such as Review, Processing, and Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready.

? Conduct Quality Control reviews of TMF Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.

? Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; maintain electronic logs which contain the location of study documents.

? Development/Contribution toward user manuals / Best Practice guides

Qualifications:

? Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.

? Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.

? Working knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, and electronic document management systems, preferably Documentum. Agility with ClinOps databases preferred.

? Basic knowledge of CFR, GCP & ICH Guidelines.

2 plus years Pharma experience (includes CRO / Vendor experience)

? Excellent written, verbal, and interpersonal communication skills.

Bachelor?s Degree preferred.

Associated topics: diet, drug, food, health, immuno oncology, immunology, nutrition, nutritionist, trauma, virus

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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