Regulatory/Quality Document Specialist
Mapp Biopharmaceutical, Inc. is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Regulatory/Quality Document Specialist is responsible for managing the logistics, preparation, maintenance of regulatory and quality documents in accordance with applicable guidelines and regulations. The Specialist will also support generation and review of important Quality/Regulatory documents and will support the functional leads on projects involving document management/quality systems. The Specialist will assist with management and authorship of SOPs and other duties as assigned.
- BS in a relevant discipline is required
- Minimum of three (3) years experience providing Regulatory/Quality document management support
- Knowledge of the drug development paradigm for New Biological Entities
- Ability to mine the FDA.gov and OUS agency websites for pertinent regulations and background information
- Strong knowledge of Microsoft Office Suite and Adobe Acrobat
- Experienced and proficient with writing technical documents suitable to technical audiences (funding organizations, Regulatory agencies, etc.)
- Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail
- Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities
- Experience with facilitation of efforts within a team from planning through to completion
- General awareness of Project Management tenets (scope, timeline, budget, risk)
- Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for US submission types (g. IND, PAS, NDA, PSUR, etc.)
- Familiarity with current regulatory submission standards and industry best practices preferred
- Knowledge of Adobe Plug-Ins (g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools is an asset
- Files and maintains archives of regulatory communications and important quality documents
- Participates in the assembly of regulatory submissions for Mapp's development and commercial stage products
- Assists with Quality Management System projects Assists with downloading, verification of Mapp documents in electronic document control system
- Plans and establishes requirements for the Quality System in accordance with applicable regulations and standards
- Assists the organization in development, documentation and implementation of policies and procedures that define, implement and support the Quality System
- Participates in the gathering of scientific data, preclinical and clinical study reports, manufacturing and analytical data and reports, and other technical information to support regulatory submissions
- Assists and/or participates in the implementation, migration, and upgrade of regulatory systems, tools and templates
- Performs document management tasks including file transfer, storage, tracking, and archiving of Regulatory submission documentation
- Establishes and maintains Regulatory submission tracker and other trackers to assist team members in understanding upcoming workload
- Develops and administers in-house training, according to Quality/Regulatory and submission project team needs, to include training on authoring templates, processes and tools critical to Quality/Regulatory endeavors
- Participates in the writing and reviewing of Regulatory communication (SOP, Work Instructions and internal guidelines)
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in Carmel, Indiana or may have the opportunity to work remotely. Travel (~<5%) will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.