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Senior Analytical Writer

2+ years
Not Disclosed
10 Aug. 8, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Role

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. With patients at the center of all that we do, we help accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Role: Analytical Writer

The Analytical Writer is responsible for writing reports of clinical or non-clinical studies performed in the Bioanalytical Laboratories of ICON, according to international guidelines, regulatory and client requirements.

Responsibilities:

  • Write bioanalytical and method validation reports by assembling data from various sources.
  • Communicate with Project Managers and Bioanalytical Team Leads about lab results and conclusions to be reported.
  • Review reports and process review comments from internal and external reviewers.
  • Finalize reports according to eCTD (pdf) requirements.
  • Create and modify templates.
  • Assist Project Managers by writing study documentation.

Qualifications:

  • Knowledge of bioanalytical laboratory processes (Bachelor level).
  • (Bio)medical background (e.g., LC-MS/MS, HPLC, ELISA, ADA, NAb, Flow cytometry).
  • Proficiency in writing and reading in English.
  • Advanced application of Microsoft Word, Excel, and Adobe.
  • Accurate, analytical, structured, communicative, and client-focused.
  • Available for 32-40 hours a week.

Benefits of Working at ICON:

Our success depends on the knowledge, capabilities, and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, we provide a comprehensive and competitive total reward package that includes an excellent base pay level and a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, due to a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please let us know through the form below.