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Principal Medical Writer, Medical Writing Services

0-2 years
Preferred by Comapny
16 Nov. 25, 2024
Job Description
Job Type: 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

Role: Principal Medical Writer

The Principal Medical Writer plays a critical role in creating, editing, and ensuring the quality of all documents associated with clinical research. This role involves authoring a wide range of regulatory documents, including protocols, clinical study reports, investigator’s brochures, informed consent forms, and summary documents. As a project lead writer and submission coordinator, the Principal Medical Writer will manage contributions from multiple writers working on related documents and serve as the primary client contact. Additionally, the Principal Medical Writer will provide technical mentoring, support process improvements, and contribute to the sales process by liaising with clients and offering input for proposals.


Key Responsibilities

Document Creation and Editing

  • Research, create, and edit clinical research documents including protocolsclinical study reportsinvestigator’s brochuresinformed consent formssummary documents, and more.
  • Serve as the project lead writer or submission coordinator and coordinate contributions from other writers.
  • Act as the primary client contact for managing communication and document delivery.

Leadership and Mentorship

  • Provide technical mentoring and training to junior medical writers.
  • Facilitate process improvements within the medical writing team.
  • Lead the development and refinement of internal standards and procedures for medical writing.

Sales and Client Interaction

  • Support Medical Writing Services management during the sales process.
  • Contribute to proposals and client liaison efforts to provide comprehensive writing solutions.

Project Management

  • Manage the variable workload and balance multiple projects simultaneously.
  • Ensure all deliverables meet the highest quality standards, ensuring attention to detail and adherence to regulatory guidelines.

Skills and Qualifications

  • 10+ years of experience in regulatory medical writing, with a proven track record of authoring key clinical research documents.
  • Expertise in a range of therapeutic areas, including vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, and more.
  • Strong communication and interpersonal skills, with the ability to lead and mentor teams effectively.
  • Experience in the pharmaceutical/CRO industry, particularly in regulatory medical writing for clinical trials and submissions.
  • Ability to work independently and manage multiple projects, demonstrating excellent time management and organizational skills.
  • Strong analytical skills, with a focus on delivering high-quality, accurate outputs.

Education

  • Bachelor’s or advanced degree (or equivalent education) in life sciences/healthcare.

Why Join?

  • Leadership opportunity to shape the medical writing process and mentor a team of writers.
  • Diverse therapeutic experience, working across a wide range of medical conditions and clinical research domains.
  • Autonomy and responsibility as a primary client contact and project lead writer.
  • Opportunity for career growth within the pharmaceutical and clinical research field.

The Principal Medical Writer role is ideal for an experienced medical writer who is passionate about ensuring the quality and clarity of clinical research documentation, while also contributing to team leadership and client relationship management.