IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
The Regulatory Officer is responsible for providing regulatory application writing support for GRA projects. The responsibilities include: researching, writing, and editing materials for regulatory submissions, including meeting briefing packages, INDs, BLAs, NDAs, Annual Reports and DMFs. In addition, the position will assist with compiling and writing ODD, RMAT, PRV and BTD applications. The Regulatory Officer will participate in project delivery and work with GRA staff and sponsors in researching, writing, and editing materials for US and Global regulatory meetings and submission. Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables
- Works with data management, clinical, toxicology and CMC, as well as sponsors to build regulatory submission documents in eCTD format including but not limited to, FDA meeting packages, ANDA, IND, NDA and BLA submissions, pediatric study plans, orphan drug designations and breakthrough designations
- Conducts complex literature searches, finalizes into written summaries for IND or NDA summary sections, or for IND and NDA annual updates
- Assists other writers in the compilation, writing, and editing of regulatory, scientific manuscript, marketing deliverables, and trade journal articles
- Manages multiple, concurrent projects
- Ensures quality of content and format of writing projects in accord with applicable regulations, guidelines,
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
- Performs other tasks or assignments, as delegated by Regulatory management.
Experience writing non-clinical, CMC and clinical (preferred but not required) sections of US and Global regulatory applications. Experience writing non-clinical (in vitro/ in vivo) protocols and reports as well as CMC/Quality Manufacturing protocols and reports or equivalent research writing experience, highly desired.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
Ability to work in a virtual organization and be effective in obtaining materials, information necessary to effectively complete projects.
Strong medical and/or scientific writing skills
Efficient project management skills
Strong knowledge of FDA regulatory requirements, Good Clinical Practice (GCP) and ICH guidelines, including strong familiarity with the eCTD format a plus
Good, solid interpersonal communication (oral and written) and organisation skills
Strong software and computer skills, including MS Office applications
Demonstrates self-motivation and enthusiasm
Demonstrates negotiation skills and is confident in making decisions with minimal supervision
Ability to work on several projects, retaining quality and timelines
Ability to follow SOPs consistently; provides independent thought to assist in process improvements
MINIMUM REQUIRED EDUCATION AND EXPERIENCE :
Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience
Plus at least 2-3 years experience* (*or combination of education, training and experience)
Bachelor's Degree, Masters or PhD
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1082483