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Regulatory Medical Writer 2 (Home-Based/Office Based) (R1065486) in Durham, NC at IQVIA™

Date Posted: 5/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    5/13/2019
  • Job ID:
    R1065486

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.

Regulatory Medical Writer 2

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.

Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.

Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.

Competence in completing good first draft clinical protocols, clinical study reports, and Investigator Brochures within a standard timeframe with limited guidance.

Good understanding of common statistical methods used in clinical trials and interpretation of their results.

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 regulatory documents.

Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.

Confidence in building relationship with customer and discussing medical 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 prioritize tasks to meet timelines. 

Demonstrated abilities in collaboration with others and independent thought.

Knowledge of regulations relevant to medical writing/technical writing, such as Good Clinical Practices (GCP) and other relevant guidances (e.g., ICH).

Careful attention to detail and accuracy.

Must be computer literate.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

A Bachelor’s degree in a life science-related discipline, communications, technical writing, or related field, advanced degree preferred, with at least 2.5 years of experience in a medical, clinical, preclinical, chemistry or related environment; or equivalent combination of education, training and experience.

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: R1065486