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Regulatory Writing Specialist, Device (Home/Office-Based) IQVIA MedTech (R1065252) in Morrisville, NC at IQVIA™

Date Posted: 3/14/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    3/14/2019
  • Job ID:
    R1065252

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

IQVIA MedTech is now hiring 2 Regulatory Writing Specialists to sit either Home/Office-Based. Must have previous Medical Device experience.

Seeking regulatory writer with experience in core clinical operations documents (IRB/EC, CEC, Protocol / CSR, IDE, and agency submissions) to work on their ever-growing book of business within the medical device and advanced therapies clinical trials. This is an exciting opportunity for a motivated regulatory writer interested in a joining a fast-paced team and a company that prides itself on delivering quality and efficient results in innovative clinical trials solutions. Preference to candidates located in or near the Raleigh-Durham NC area, this position offers a great deal of flexibility to work remotely.

  • Lead the preparation of all clinical and regulatory deliverables including but not limited to CSRs, Protocols, IBs, CTD Modules and major IDE / 510(k) / PMA submissions in collaboration with members of client authoring teams
  • Develop a pivotal role in supporting the development, implementation, and improvement of internal processes and SOPs
  • Build strong, lasting relationships with client teams from small/midsized venture clients and large top 50 partners
  • Review all regulatory/clinical documents composed by contributing and supporting writers
  • Responsible for providing document-specific advice to clients, offering both a consultative and regulatory writing service
  • Engage with medical technology key opinion leader and client staff to understand medical devices and digital health systems in a fast-paced environment
  • Interpret and break down data from varying sources of clinical information

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 in life science, communications or related field

•           3 years related work experience in regulatory affairs or clinical writing

•           Or, equivalent combination of education, experience and training

CLASSIFICATION:

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

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1065252