Regulatory Writing Specialist (Home or Office-Based) - IQVIA Biotech (R1106342) in Morrisville, NC at IQVIA™

Date Posted: 2/9/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    2/9/2020
  • Job ID:
    R1106342

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.

BASIC FUNCTIONS:

Prepares, reviews and coordinates the preparation of regulatory clinical trial documents for either internal customers or external clients.  Documents may be related to investigational drugs, biologics or medical devices and content consistent with industry practice and client specifications.  Participates in project teams and may lead specific tasks consulting senior staff as necessary.  Builds strong, lasting relationships with client teams.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Leads the preparation of all chemistry manufacturing and controls (CMC), and regulatory documents including, but not limited to, CTD Modules of initial IND, pre-IND packages, EU MPD, clinical trial applications to Health Canada, clinical trial applications in Europe in collaboration with internal teams and members of client authoring teams
  • Supporting the development, implementation, and improvement of internal processes and SOPs
  • Performs gap analysis of CMC packages of client’s investigational products and provides CMC strategy for the drug product development
  • Reviews all regulatory/CMC documents composed by contributing and supporting writers and regulatory staff
  • Responsible for providing document-specific advice to clients, offering both a consultative and regulatory writing service
  • Engages with key opinion leader and client staff to understand CMC aspects of new investigational drug products in a fast-paced environment
  • Interprets and breaks down data from varying sources of CMC information
  • Performs other duties as assigned

KNOWLEDGE, SKILLS AND ABILITIES:

  • Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
  • Demonstrated CMC knowledge, chemical or biologic products.
  • Familiarity with the structural and content requirements of CMC or method validation and batch manufacturing records, and similar documents for internal and external clients.
  • Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
  • Competence in completing good first draft technical reports or CMC modules within a standard timeframe with limited guidance.
  • Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned.
  • Ability to identify deficiencies, errors, and inconsistencies in a report or regulatory documents.
  • Confidence in building relationship with customer and discussing CMC/technical report writing issues with customers in person, via e-mail or on the telephone.
  • Can provide thorough, appropriate and sensitive feedback to peers upon request to review a document.
  • Ability to work on several projects at once while balancing multiple and overlapping timelines.
  • Ability to assess workload and suggest prioritization to senior staff.
  • Demonstrated abilities in collaboration with others and independent thought.
  • Knowledge of regulations relevant to medical writing/technical writing
  • Careful attention to detail and accuracy.
  • Must be computer literate.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

PHYSICAL REQUIREMENTS:

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • May require occasional travel.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s degree (or equivalent) in chemistry/biochemistry, life science, communications or related field; advanced degree preferred.
  • 5 years related work experience in regulatory affairs and/or CMC writing
  • Equivalent combination of education, experience and training

CLASSIFICATION (US):

This position is classified as exempt under the Fair Labor Standards Act.

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: R1106342