Senior Specialist, Trial Master File

Altria Client Services

Richmond, Virginia

5/30/2019 5:04:24 AM

19092BR

Regulatory Sciences

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Altria Group is a FORTUNE 200 company that holds diversified positions across tobacco, alcohol, and cannabis. Altria’s mission is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products.

Altria Client Services’ role is to provide high-quality services to the Altria family of companies. In support of that mission, we are currently seeking a Senior Specialist, Trial Master File to join our Science Operations team in Richmond, VA. Your role will be to develop and manage the Clinical Operations Trial Master File program in support of clinical study execution.

You will:

* Develop, plan and manage the Trial Master File process and associated infrastructure including contract resources.
* Supervise the study TMF set-up: organizes and leads the TMF kick-off meeting with key representatives from the Clinical Team. Based on the specific organization of the trial, you will evaluate the risks with regards to the TMF.
* Provide direction to the Clinical Documentation Coordinators and partner CROs in the processing of the TMF documents to ensure TMF Document Quality, proper indexing /filing and real-time management of documents submitted to the TMF.
* Organize and perform TMF Readiness checks at key study milestones. Propose and lead any corrective action plan.
* Report study TMF progress or any issue to the Clinical Team and the Operations Manager in charge of the program.

Specific Skills

You have:

* Bachelor's degree required, Advanced degree preferred.
* 3+ years of experience in clinical trials. Experience with clinical research document control ALCOA requirements (Attributable, Legible, Contemporaneous, Original and Accurate).
* Knowledge of FDA tobacco product applications/regulations, ICH guidelines, GCP practices. Awareness and knowledge of applicable clinical research regulatory requirements (Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines)
* Proficiency in Microsoft office products and professional writing skills.
* Understanding of regulatory document review. Overall willingness to learn the tobacco industry and the growth of regulations relating to clinical research.

Altria is a Fortune 200 company, proud to call Richmond, Virginia our home.

Altria Group holds diversified positions across tobacco, alcohol, and cannabis. Our tobacco companies include some of the most enduring names in American business: Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton and Nat Sherman. We also have 35 percent ownership of JUUL Labs, Inc., the nation’s leading e-vapor company; and a 45 percent ownership of Cronos Group, a leading Canadian cannabis company. We complement our total tobacco business with our ownership of Ste. Michelle Wine Estates and our significant equity investment in Anheuser-Busch InBev, the world's largest brewer.

Altria Client Services’ role is to help Altria Group and its operating companies responsibly meet their business goals by providing the high-quality services they require in a financially disciplined way. We believe in developing the leadership potential of our employees by providing opportunities for training, development, and advancement.

In addition to the opportunity to apply and develop your skills toward key business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package.

NOTE*

Each Altria company is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class.



Richmond, VA - Virginia



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