Regulatory Medical Writer

Employer
IQVIA - Australia
Location
Melbourne, Victoria; Melbourne, Australia; St Leonards, Australia
Salary
Competitive
Closing date
10 Oct 2020

View more

Discipline
Regulatory Affairs, Regulatory Writing
Hours
Full Time
Contract Type
Permanent
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As a Medical Writer you will prepare, or contribute to the preparation of clinical documents, for either internal customers or external clients, for investigation drugs, biological, or medical devices. You will collaborate with internal experts and specialists; conducts thorough research; maintains expertise on developments in a particular field of focus.

The successful candidate will have excellent attention and accuracy with details, strong individual initiative, organizing skills and commitment to quality. They will also have the ability to establish and maintain effective working relationships with co-workers, managers and clients.

Various ANZ locations can be considered for this role.

Responsibilities:
  • Acts as experienced/lead Medical Writer on a variety of writing projects, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with IQVIA SOPs and the customer's requirements as well as to the agreed timelines .
  • Participates in both internal and external project team meetings and liaises directly with the customer on medical and/or technical writing issues, as appropriate and with senior support as needed.
  • Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance.
  • Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
  • Performs quality control (QC) and peer review of clinical study reports and other deliverables written by other medical writers.
  • Offers proactive solutions and advice to customers as appropriate to experience.
  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
  • Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or medical writing.
  • Complies with IQVIA SOPs and participates in the implementation of new SOPs.

Key requirements:
  • Must hold Bachelor's degree in Life Sciences/Pharmacy. Preferably holding an advanced degree (Masters). PhD not necessary
  • Ideally must hold a minimum of 3 years' experience in writing regulatory clinical documents: clinical study reports (CSRs), protocols and Investigator Brochures (IBs) ideally, all of which gained in a Pharma/CRO setting. Experience with other document types (IND submissions, NDAs/CTDs, manuscripts, abstracts, posters, etc) will be a plus.
  • In-depth knowledge of drug development, medical writing and associated regulations. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
  • Understanding of statistical principles and medical terminology across a range of therapeutic areas.
  • Excellent written and oral communication skills in English, which includes grammatical and technical writing skills .
  • Equivalent experience, education and/or training may be substituted for the education requirements.
  • Must be well organized, be able to meet tight deadlines, be detail-oriented and a team player.
  • Must have the ability to be flexible and work independently.
  • Must have the ability to communicate interpersonally, to track information, to communicate visually or graphically.
  • Must demonstrate the ability to handle multiple priorities and interface with individuals from various departments.
  • Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access and PowerPoint

If you are interested in this position please apply and a member of our Talent Acquisition team will be in contact

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

Let's do better, together.

From research to real world, IQVIA weaves together the technologies, resources, and expertise our customers need to rise to the next opportunity. To look beyond what’s expected. To advance human health with newfound confidence.

 

Ready for today, prepared for tomorrow

IQVIA uses Human Data Science — the integration of data science, technology, and human science — to help customers address both current needs and future opportunities. But to get there, to make Human Data Science work, for you, you need a seamless integration of unparalleled data, advanced analytics, transformative technology, and deep domain expertise. You need the IQVIA CORE.

 

Contact Us
  • Level 8
  • 201 Pacific Highway
  • St Leonards
  • 2065
  • AU
  • +61 2 9805 6800
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