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Senior Regulatory Medical Writer (CSR / Protocols)

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Primary Location: Livingston, West Lothian, United Kingdom Additonal Locations: Amsterdam, Netherlands,NLD; Antwerp, Belgium,BEL; Aschheim, Germany,DEU; Athens, Greece,GRC; Barcelona, Spain,ESP; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Dublin, Ireland,IRL; Kaunas, Lithuania,LTU; Ljubljana, Slovenia,SVN; Milan, Italy,ITA; Milan, Italy,ITA; Oeiras, Portugal,PRT; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sarajevo, Bosnia,BIH; Sofia, Bulgaria,BGR; Tallinn, Estonia,EST; Vienna, Austria,AUT; Warsaw, Poland,POL; Zagreb, Croatia,HRV Full time R1300717

Job description

Due to expansion, we are looking for multiple Senior Medical Writers with experience in the International Council for Harmonization's (ICH) Common Technical Document (CTD), Module 5 (Clinical Study reports and Protocols)

You will Prepare or contribute to the preparation of clinical and/or regulatory documents, for either internal customers or external clients, for investigational drugs or biologicals. Collaborating with internal and external experts and specialists; maintains expertise on developments in a particular field of focus.

This role can be conducted within Europe, it can be home, office or Hybrid based for the right candidate.

About us:

"IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.    

Why IQVIA? Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

Role Overview:

  • Acting as Lead Medical Writer on most types of writing projects. Preparing assigned documents in accordance with company Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments.
  • You will provide written and verbal feedback to junior staff, and to customers when appropriate.
  • You will Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Responsibilities

  • Taking a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the customer.
  • Planning and organising workload for assigned projects and tasks: identify project needs, track timelines, and implement customer requests.
  • Leading meetings on more challenging topics independently.
  • You may present on standard Medical Writing processes at full-service bid defence meetings.
  • Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.
  • May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
  • Complete project finance activities, including monitoring and forecasting budgeted hours.
  • Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
  • May take on a small customer lead role or assist an established partnership lead in their role.
  • May represent region or site on a Medical Writing initiative or cross-functional initiative.
  • Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.

Do you meet the minimum education and experience requirements below?

  • You have Regulatory Medical Writing experience, typically this would be demonstrated by 3 - 5 years + Writing Clinical Study reports and Protocols. (Required)
  • You have a BSc in a life sciences or related discipline / related field (Required)
  • If you have a MSc or PhD this would be advantages but is not essential.
  • You can effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output        
  • You can integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
  • You have an in-depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.            
  • You have the right to live and work in the UK, EEA, or EU without needed sponsorship.

Skills and Abilities

  • Excellent written and oral communication skills including grammatical/technical writing skills in English.          
  • Excellent attention to detail and accuracy.                 
  • Confident and effective communication and negotiation skills with customers and project managers.
  • Able to deliver difficult messages in constructive manner.           
  • Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.              
  • Demonstrated abilities in collaboration with others and independent thought.                        
  • Demonstrates confidence and maturity in most routine medical writing situations.                 
  • Demonstrates good judgement in requesting input from senior staff.                          
  • Ability to establish and maintain effective working relationships with co-workers, managers, and customers.               
  • Ability to effectively manage multiple tasks and projects.            
  • Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

Apply now

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