Senior Manager, Regulatory Informatics

United Therapeutics Corporation Silver Spring , MD 20901

Posted 3 months ago

The Job Details are as follows:

What we do

About United Therapeutics

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens having a positive impact on patients, the environment and society will sustain our success in the long term.

We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you'll contribute

Drives improved performance and process optimization by managing company's Regulatory Information Management (RIM) systems, including publishing, submissions viewer, registration tracking, and content management solutions. Manages electronic regulatory submissions from creation through archival, global data standards, definition and revision of business process, and project/information management.

Key Job Responsibilities

  • Oversee portfolio of Regulatory information systems necessary to meet needs of Regulatory Affairs and other departments within the company

  • Manage overall functionality of RIM systems to maximize efficiencies within UT and subsidiaries, eliminating need to maintain redundant information in multiple systems.

  • Maintain scalable Regulatory systems, minimizing possibility of UT and subsidiaries needing to migrate to new systems as Regulatory requirements evolve

  • Supervise and develops Regulatory Informatics staff, including coordinating activities of contract or regulatory consultants as necessary

  • Proactively solicit feedback from user community on enhancements and upgrades for RIM systems

  • Oversee configuration changes and validation of RIM system

  • Manage changes to RIM's system objects, including product dictionaries, clinical and nonclinical dictionaries, configuration changes and validation of RIM systems

  • Function as the subject matter expert and primary resource for UT and subsidiaries on regulatory submission technical requirements

  • Assist with the preparation, submission, and maintenance of new and existing regulatory applications in compliance with evolving health authority requirements

  • Act as the primary contact to communicate regulatory submission requirements and ensure preparation according to defined templates and timelines

  • Interact with internal and external stakeholders as the primary contact for regulatory informatics and technical aspects of regulatory submissions

  • Ensure proper life-cycle management for electronic regulatory submissions

  • Represent Regulatory Informatics at internal team meetings

  • Interact with partner companies and regulatory agencies to ensure all technical requirements for submissions and documents are met

  • Develop and maintain standardized authoring templates for documents, ensuring the templates meet the technical requirements of FDA, EMA, HC, and ICH

  • Oversee the document formatting process to ensure documents meet the requirements of different Health Authorities

  • Work with Regulatory Agencies, Stakeholder Organizations (e.g., Implementation of Regulatory Submission Standards [IRISS], Health Level 7 [HL7]), and sponsors to assist in developing and testing data standards, ensuring standards address needs of UT's product portfolio

  • Manage implementation of data standards (e.g., Identification of Medicinal Product [IDMP]), including ensuring systems meet evolving agency requirements, managing system configuration changes as needed, data mapping, educating internal stakeholders

  • Collaborate with Regulatory Affairs on agencies' requirements for data standards, ensuring no submission is rejected for not meeting requirements

  • Create, edit, and revise SOPs and department business process documents

  • Perform other duties as assigned

For this role you will need

Minimum Qualifications

  • BA/BS degree

  • 8+ years direct experience with electronic document management and regulatory submissions experience

  • 3+ years of experience managing direct reports

  • Familiarity with drug development process, FDA and ICH guidelines, regulatory submission process and application types for US and Canada

  • Strong attention to detail and proven organizational skills with strong ability to prioritize workload.

  • Experience and comfort in working independently and as part of a multi-functional team

  • Ability to handle high workloads, stressful situations, and deadlines

  • Ability to interact and communicate effectively, both verbally and in writing, with colleagues and executive management, cross-functional teams, external government personnel, and clinical investigators and site personnel

  • Advanced knowledge of EDMS and publishing software

  • Experience and continuing education with eCTD, Regulatory systems, and data standards

  • Expertise in RIM software applications and with MS Office, Adobe Acrobat, and required productivity applications.

  • Ability to travel up to 25% as needed

Preferred Qualifications

  • Experience with ISI Toolbox, Veeva Vault RIM, and Lorenz docu

Bridge

Life as a Unitherian

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our Company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities


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Senior Manager, Regulatory Informatics

United Therapeutics Corporation