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Principal Medical Writer, Medical Writing Services

10+ years
Not Disclosed
10 Jan. 8, 2025
Job Description
Job Type: Full Time 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

Join Us at Parexel - Principal Medical Writer
At Parexel, we share one common goal: to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is driven by a shared belief in what we do. We are committed to the development of therapies that ultimately benefit patients. Each of us, regardless of role, makes a meaningful contribution with empathy, care, and dedication.

We are seeking a Principal Medical Writer who will be responsible for researching, creating, and editing all documents associated with clinical research. The Principal Medical Writer will act as the project lead writer or submission coordinator and serve as the primary client contact, managing contributions from multiple writers on related documents. Additionally, the role involves facilitating process improvements, mentoring, and providing technical training. This position will also support the Medical Writing Services management during the sales process by offering client liaison and proposal input.

Minimum Qualification Requirements:

  • 10+ years of experience in regulatory medical writing.
  • Experience in authoring protocols, clinical study reports, investigator brochures, informed consent forms, summary documents, etc.
  • Expertise in multiple therapeutic areas including vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, etc.
  • Strong communication and interpersonal skills.
  • Bachelor’s or advanced degree in life sciences/healthcare or equivalent.
  • Experience in the pharmaceutical/CRO industry.
  • Ability to work independently and lead projects.
  • Strong analytical skills and attention to detail.
  • Ability to manage a variable workload while ensuring high-quality outputs.