What are the responsibilities and job description for the Trial Master File (TMF) Specialist position at Tbwa Chiat/Day Inc?
About QED Therapeutics & BridgeBio Pharma
Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.
QED Therapeutics, an affiliate of BridgeBio Pharma , focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
Our business is inspired by our values :
- PUT PATIENTS FIRST
- EVERY MINUTE COUNTS
- THINK INDEPENDENTLY
- BE RADICALLY TRANSPARENT
FGFR=fibroblast growth factor receptor.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at https : / / www.qedtx.com / | https : / / bridgebio.com
Reporting to the Senior Manager, TMF Operations, the TMF Specialist is an important study team member working closely with Clinical Operations and Quality Assurance on ensuring a high quality and complete eTMF for our ongoing clinical trials. With the ultimate objective of constant inspection readiness for a pivotal program, the TMF Specialist, as an individual contributor, will be responsible for supporting the processes outlined in the TMF Plans, and associated processes / documents, established for our studies (at QED and the CRO) to support timely, accurate, and complete submission of documents to the eTMF by all study team representatives, as well as supporting overall eTMF activities. The TMF Specialist is a vital link between the day-to-day operations of the clinical project and the ultimate collection of documentation providing evidence of applicable compliance to regulatory authorities’ requirements and expectations. The TMF Specialist plays an integral role in the quality control review of all TMF documents, in support of the Senior Manager, TMF Operations.
Responsibilities
No matter your role at BridgeBio, successful team members are :
Education, Experience & Skills Requirements
What We Offer
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
90,000 - $120,000 USD
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Salary : $90,000 - $120,000
