Reg Affairs Officer 2 (R1082483) in Rockville, MD at IQVIA™

Date Posted: 6/19/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Rockville, MD
  • Experience:
    Not Specified
  • Date Posted:
    6/19/2019
  • Job ID:
    R1082483

Job Description

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.

PURPOSE:

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorization activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.

RESPONSIBILITIES :

• Lead and manage regulatory activities related to asset transfers following established organizational processes and procedures.

• Manage regulatory projects planning, execution, and monitor & control efforts, report on progress, manage project closing as required.

• Work with project leadership, team and other stakeholders preparing project plans and associated agreements.

• Organize, attend and facilitate cross-functional and regulatory meetings as needed.

• Coordinate tracking and delivery of the project strategic plans including preparation of regulatory submissions, provide status updates as required.

• Lead and/or assist in Regulatory Risk management efforts for the assigned projects.

• Ensure collaborative relationship with the assigned project internal and external stakeholders.

• Responsible for timely and seamless delivery of the assigned work.

• Assist with location of documents, ad hoc requests or communication of the project plan.

• If assigned, lead a broad cross-functional teams.

• If assigned, act as the Patient Safety and Regulatory Affairs lead in the cross-functional teams

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Highly organized, proactive and detail oriented

• Skilled communicator and facilitator

• Effective time manager

• Proficiency in standard business productivity tools (e.g. Microsoft Office package)

• Strong understanding of regulatory and patient safety documentation, and GDP

• Knowledge/experience in systems for document storage and retrieval

• Strong team building capabilities

• Good organization and problem-solving skills

• Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE :

• Bachelor’s degree in a Health or Science field. MS is preferred. PM formal training is preferred.

• Minimum 7 years of biotechnology/pharmaceutical industry experience working in regulated environment.

• 1 or more years in a Project Management role or equivalent.

• 6 or more years working in a Regulatory role including assisting in the developing regulatory submission documents and coordinating delivery to submission plans.

Patient Safety/Pharmacovigilance experience is highly preferred.

• Experience in regulatory requirements for asset transfers is highly preferred.

• Knowledgeable in worldwide RA and PV Regulations, ICH guidance

Join Us

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 workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1082483