Senior Regulatory Medical Writer - Homebased or Office Based in Durham, NC - (1722727) in Durham, NC at IQVIA™

Date Posted: 11/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    At least 3 year(s)
  • Date Posted:
    11/10/2018
  • Job ID:
    1722727

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.

Description

Lead the preparation of high quality regulatory documents, for either internal IQVIA customers or external clients, for investigational drugs, biologics, biosimilars, or medical devices.
 
Primary Duties and Responsibilities:
  • Act as Lead Medical Writer, with limited guidance from supervisory staff, and maintains consistent high quality and efficiency.
  • Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed.
  • Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance.
  • Offers proactive solutions and advice to customers as appropriate to experience.
  • Reviews and monitors budget for assigned projects, including identification of out of scope activities, and ensures that revenue is recognized as appropriate.
  • Provides senior review, and guidance for documents prepared by junior staff.
  • May coordinate Medical Writing activities for a series of full-service projects, with focus on efficiencies, consistency, client liaison, and tracking.

Job Requirements

Excellent written and oral English communication skills. Superior attention to detail with regard to in spelling, punctuation, grammar, consistency, clarity, and accuracy.  Ability to communicate effectively with colleagues and customers. High level and in-depth knowledge of the structural and content requirements of regulatory clinical documents such as clinical study reports, protocols, and investigator brochures.  Experience with the clinical modules of the CTD (ISE, ISS, 2.7, 2.5) is also desired. Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. Demonstrated ability and experience to work independently on most writing projects.  Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
 
 Minimum of Bachelor’s degree in a life science-related discipline, advanced degree preferable, with at least 3 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including extensive experience in preparing all types of regulatory documents with consistently positive customer feedback; 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™.”

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: 1722727