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Regulatory Operations RIM Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Closing date
Mar 19, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Organization Type
Biotech
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Job Details

Primary Duties

The Regulatory Operations RIM Lead is responsible for the day-to-day operational performance of the Regulatory Information Management (RIM) group. She/he is responsible for maintaining the correspondence and registrations tracking systems and also the Veeva RIM submission document and archive vaults as the Veeva admin/system owner in accordance with Spark policies, guidelines, and procedures. He/she will work with all of Spark’s global regulatory affairs department to identify new issues or unmet needs and initiate projects or programs to address them. She/he will also work closely with Spark’s IT organization to understand and translate needs into actionable work and support efforts. This individual represents the Regulatory Operations group on multi-disciplinary and cross-functional teams and establishes relationships to influence and lead. The incumbent will be involved with Veeva trimester configuration upgrades, validation projects, and change controls. The company’s historical paper archive will be overseen by this individual.

Responsibilities

Job Function and Description

Function as the Veeva Admin for the RIM submission document vault (including the PleaseReview tool) and the archive vault. Assist all users with issues in finding documents, obtaining accounts, managing workflows, and all other troubleshooting requests. Active in the Veeva trimester upgrades by evaluating, configuring, testing, and training in conjunction with IT.

Function as the Admin for the correspondence and commitment system which catalogs all of the health authority communications to and commitments by Spark.

Collaborate with Regulatory Affairs team to explore new systems and processes improving how documents are created and used effectively in health authority applications to bring our gene therapies to the patient community.

Manage the Regulatory Information Management team to achieve business goals and objectives.

  • Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
  • Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
  • Develop people. Understand each individual team member’s career goals. strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

Education and Experience Requirements

  • This role typically has an advanced degree with 7+ years Regulatory Information Management experience or a minimum of a BA/BS degree with 10+ years of relevant experience.
  • Extensive understanding of RIM and regulatory operations including demonstrated ability to develop and implement global RIM systems processes.
  • Proficient in use of RIM tools; such as electronic document management systems, registrations/correspondence and commitments databases/systems/tools.
  • 3+ years as a Veeva RIM Vault system owner/Admin
  • Demonstrable experience interfacing with IT organizations and translating tech and business needs to critical stakeholders

Key Skills, Abilities, and Competencies

  • Function as the Veeva admin for the RIM Submission Document and the Archive Vaults.
  • Oversee the management of databases for registrations and correspondence with health authorities globally.
  • Oversee the management of hard copy records storage.
  • Review prior records for any systematic errors or ways to improve tracking or accessibility, and then develop and implement upgrades.
  • Work with IT on Veeva trimester upgrades; writing or performing UAT.
  • Solve user challenges with documents, provide templates, correct errors made by users.
  • Experience with PleaseReview is a plus.
  • Manage user accounts (creation, changes, termination), create How-To guides, keep guides/processes/training materials current, conduct user training, update system FAQs.

Complexity and Problem Solving

  • Manage the RIM group; hiring, recommending annual compensation and promotion.
  • Troubleshoot problems with RIM systems, i.e. Veeva, PleaseReview, HA correspondence, Registrations.
  • Oversee management of the paper archival system, interpreting policies for specific issues.
  • Management of the day-to-day operations of the RIM systems.
  • Recommend new processes and systems for RA or Development to utilize, with the final decision to be made with senior management and the team impacted.

Internal and External Contacts

Internal

  • Work with IT on Veeva trimester upgrades; writing or performing UAT.
  • Work with RA and SMEs in R&D to troubleshoot problems, manage document templates, assist with generalized Veeva misunderstandings, train.
  • Work with Regulatory Operations team to determine how systems can work with each other to increase efficiency in planning, preparing, publishing, reviewing, approving, dispatching, and archiving documents and dossiers.
External

  • Work with Veeva on trimester upgrades and evaluating new vaults for synergy with existing vaults.
  • Work with vendors to troubleshoot problems with current systems and provide feedback for improvements needed.
  • Work with potential new vendors to evaluate their system for applicability to Spark’s needs for the functionality.

#LI-Remote

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Mini-site
Spark Therapeutics
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
US
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