You haven't searched anything yet.
Job Title: | Senior Manager/Manager Regulatory Document Submissions |
Location: | Remote |
Position type: FLSA: | Full time Exempt |
Department: | Regulatory Affairs |
At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
Position Overview
The Senior Manager/Manager Regulatory Document Submissions will report to the Director of Medical Writing, Regulatory. This position will partner with Regulatory Affairs as the department brings publishing and submissions in-house. This position will serve as an integral team member during system configuration, validation, and migration of historical documents into Veeva.Once the system is implemented, administration responsibilities will include ongoing system maintenance and development through regular meetings with the Veeva support team, validation of new system functions when added, and collaboration efforts with RA strategists, medical writers, IT, on methods to optimize RIM system use. Additionally, post implementationthe role will expand into submissions management.
What You Will Contribute
What We Seek
Avidity Biosciences | 10578 Science Center Dr. Suite 125 | San Diego, CA | 92121 | O: 858-401-7900 | F: 858-401-7901 |
Full Time
Pharmaceutical
$104k-130k (estimate)
03/07/2024
05/06/2024
aviditybio.com
La Jolla, CA
25 - 50
Pharmaceutical