Medical Writer 2 - (R1028682) in Ithaca, NY at IQVIA™

Date Posted: 6/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Ithaca, NY
  • Job Type:
    Regulatory
  • Experience:
    At least 5 year(s)
  • Date Posted:
    6/5/2018
  • Job ID:
    R1028682

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.

Description

PURPOSE
Prepares, or contributes to the preparation of more advanced or complex clinical documents, for either internal Quintiles
customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff.
Participates in project teams and may lead specific tasks, consulting senior staff as necessary.

RESPONSIBILITIES
  • Acts as Lead Medical Writer on more advanced writing projects and performs competently, with guidance from senior staff
  • as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with
  • Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client
  • requests with senior review.
  • Participates in both internal and external project team meetings and liaises directly with the customer on medical writing
  • issues, including setting of project timelines, as appropriate and with senior support as needed.
  • Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
  • May perform QC review of documents or parts of documents prepared by more senior staff.
  • May deliver basic level training to small groups or individuals within Quintiles on the role of the medical writer.
  • Takes responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff.
  • Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug
  • development/medical writing.
  • Complies with Company SOPs and participates in the implementation of new SOPs.

All responsibilities are essential job functions unless noted as nonessential (N).

Job Requirements

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 a good first draft clinical study report in any therapeutic area within a standard timeframe with
  • limited guidance, and ability to prepare a good first draft protocol, with senior 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 a protocol.
  • Ability to effectively review a statistical analysis plan.
  • Ability to identify deficiencies, errors, and inconsistencies in statistical output.
  • Confidence in building relationship with customer and discussing Medical Writing issues with customers in person 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.
  • 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
  • Bachelor’s degree in a life science-related discipline, plus 2.5 years' experience as a medical writer within a
  • pharmaceutical environment; or equivalent combination of education, training and experience
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
  • Occasional travel
EEO 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: R1028682

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