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Medical Writer 2

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Primary Location: Durham, North Carolina, United States Full time R1234252

Job description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Job Summary:

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.

Requirements:

  • 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

Minimum Required Education and Experience:

  • Bachelor’s degree in Life Science, Communication and related Field plus 3 years related work experience in regulatory affairs or clinical writing OR Equivalent combination of education, experience and training.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.

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