Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. 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. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). 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.

The Opportunity

The Manager, Training, reporting to the Associate Director, Document Management and Training, will assist in the daily management of Veeva Vault Training and overall training program compliance.

The candidate will facilitate new hire onboarding training assignment, maintain organizational training curriculum and personnel training records, monitor training completion, and provide compliance metrics to QA management.

What You Will Contribute

• Serve as Veeva Vault Training Administrator, facilitating GxP new hire orientation, curriculum assignment for new/existing GxP employees, and overall GxP training program management.
• Collaborate with Document Control and GxP department management to assess and implement training requirements for new SOPs.
• Assist with the development of Veeva Vault Training user training materials, including SOPs, and provide technical and training support to users.
• Establish and maintain employee training files and curriculum records, including on-boarding/off-boarding of employees and consultants.
• Assist with the development of New Employee Orientation course content in Veeva and deliver live training as requested by QA management.
• Facilitate annual and ad hoc curriculum review with department heads to ensure appropriate assignment of training.
• Conduct annual training record review to ensure regulatory compliance and inspection readiness.
• Coordinate and facilitate Annual GxP Training requirements.
• Compile and report training compliance metrics for management review.
• Partner with IT to support Veeva system change control activities for new release validation.
• Provide feedback to Veeva on LearnGxP course offerings and facilitate requests for new content.
• Serve as backup Veeva Quality Docs Document Administrator and support document control functions.
• Perform other duties and complete special projects as required.

What We Seek

• Minimum of Bachelor’s degree in a relevant scientific discipline or equivalent.
• Minimum of 8 years of experience in document management, preferably in the biopharma industry.
• Minimum of 2-3 years of experience in Veeva Vault Training administration and proficiency with Veeva Quality Docs.
• Experience in managing and maintaining GxP and corporate training programs, and Document Control systems.
• Strong knowledge of GxP/FDA regulations and experience in supporting regulatory inspections.
• Strong written and verbal communication and interpersonal skills.
• Commitment to supporting internal and external teams and customers.
• Meticulous attention to detail and well organized.
• Ability to multi-task, shift priorities, work in a fast-paced environment, and adeptly solve problems.
• Effectively collaborate as a team player in a highly matrixed organization, demonstrating professional demeanor, enthusiasm, and self-motivation.
• Ability to travel to the San Diego office 3-4 times per year.

What We will Provide to You:

• The base salary range for this role is $137,750 - $152,250. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity, and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.