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Senior Medical Writer

0-2 years
Preferred by Comapny
10 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: Senior Medical Writer

The Senior Medical Writer plays a key role in researching, creating, and editing clinical research documents. In this position, the Senior Medical Writer may serve as the project lead writer and submission coordinator, overseeing contributions from multiple writers working on related documents. Additionally, the Senior Medical Writer will support the Medical Writing Services management team, providing technical mentoring, facilitating process improvements, and assisting in the sales process by liaising with clients and contributing to proposals.


Key Responsibilities

Document Creation and Editing

  • Research, create, and edit a variety of clinical research documents, including protocolsclinical study reportsinvestigator’s brochuresinformed consent forms, and summary documents.
  • Serve as the project lead writer or submission coordinator for major projects and coordinate the efforts of other medical writers.
  • Act as the primary client contact, managing communication, ensuring deadlines are met, and delivering high-quality content.

Leadership and Mentorship

  • Provide technical mentoring and training to junior writers within the team.
  • Contribute to process improvements and standardization of writing practices.
  • Provide leadership in guiding and reviewing the work of other writers.

Sales and Client Interaction

  • Support Medical Writing Services management in the sales process.
  • Participate in client liaison, offering writing expertise and input during proposal discussions.

Project Management

  • Manage the variable workload effectively, balancing multiple projects with different priorities and timelines.
  • Ensure all documents meet the highest standards of quality, ensuring attention to detail, accuracy, and adherence to regulatory guidelines.

Skills and Qualifications

  • 6+ years of experience in regulatory medical writing, with experience in creating key clinical research documents.
  • Experience in multiple 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 manage teams effectively.
  • Experience in the pharmaceutical/CRO industry, particularly in medical writing for regulatory documents.
  • Ability to work independently while managing multiple projects, with excellent organizational and time management skills.
  • Strong analytical skills and a commitment to producing high-quality, error-free documents.

Education

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

Why Join?

  • Leadership opportunity to manage complex writing projects and lead teams.
  • Exposure to a diverse range of therapeutic areas, enhancing professional growth and expertise.
  • Collaborative work environment, with opportunities for technical mentoring and process improvement.
  • Career advancement within the pharmaceutical and clinical research industry.

The Senior Medical Writer role is ideal for a highly skilled medical writer with experience in regulatory documents and clinical trials, who enjoys managing multiple projects, mentoring others, and contributing to the success of client relationships and proposals.