Medical Writer
A Medical Writer creates scientific documents that detail research findings, product use, and other medical information. They primarily work for pharmaceutical companies, healthcare agencies, or medical publishers.
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Sample Job Descriptions for Medical Writer
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
As a Junior Medical Writer, you will be responsible for creating clear and coherent medical documents for clients in the pharmaceutical industry, healthcare agencies, and academic institutions. Your role includes drafting research articles, clinical study reports, and regulatory documents while ensuring that all content adheres to industry standards and guidelines.
Required Skills
- Strong writing and editing skills.
- Proficiency in Microsoft Office and document management systems.
- Ability to interpret and present clinical data and other complex information.
- Understanding of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Critical thinking and problem-solving skills.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field.
- Excellent writing and communication skills.
- Understanding of the drug development process and regulatory requirements.
- Familiarity with medical terminologies and a keen attention to detail.
- Ability to work in a team and manage multiple projects in a fast-paced environment.
Responsibilities
- Drafting and editing clinical trial reports, research articles, and other scientific publications.
- Ensuring documents comply with regulatory, journal, or other guidelines.
- Communicating scientific information in a clear and concise manner.
- Collaborating with healthcare professionals and clients to gather the necessary information for document preparation.
- Assisting in the preparation of presentation materials for medical conferences.
- Performing literature searches and reviews to understand current medical and scientific knowledge.
Intermediate (2-5 years of experience)
Summary of the Role
We are seeking a dedicated Medical Writer with a keen eye for detail and the ability to synthesize complex scientific information into clear, well-structured documentation. The ideal candidate will support our clinical and regulatory teams in creating a range of scientific materials, such as clinical study reports, regulatory submission documents, and journal manuscripts, to communicate effectively with both scientific and lay audiences.
Required Skills
- Excellent written communication and editing skills
- Ability to interpret and present clinical data and other complex information
- Strong attention to detail and organizational skills
- Proficiency in MS Office and document management software
- Ability to work independently and collaboratively in a team environment
Qualifications
- Bachelor's degree in a life sciences discipline; advanced degree preferred
- At least 2 years of relevant medical writing experience in the pharmaceutical, biotech, or clinical research organization (CRO) industry
- Familiarity with regulatory guidelines (e.g., ICH, EMA, FDA) and Good Clinical Practice (GCP)
- Proven track record of high-quality clinical and regulatory document preparation
- Experience with electronic document management systems
Responsibilities
- Prepare, edit, and review clinical and regulatory documents in compliance with international standards and guidelines
- Collaborate with clinical teams to ensure accurate representation of study data
- Ensure documents are clear, concise, and scientifically accurate
- Manage the process of writing, including timelines, review cycles, and document quality
- Stay abreast of industry best practices and contribute to the development of internal writing guidelines
- Support the preparation of journal manuscripts, abstracts, and presentations for scientific congresses
Senior (5+ years of experience)
Summary of the Role
We are seeking a highly skilled and experienced Medical Writer to join our dynamic team. The ideal candidate will have a strong background in medical research and writing, with the ability to communicate complex scientific information clearly and effectively. As a Senior Medical Writer, you will be responsible for developing clinical documents, scientific publications, and regulatory submissions that meet the highest standards of quality and accuracy.
Required Skills
- Superior writing and editing abilities.
- Ability to interpret and present clinical data and other complex information.
- Strong attention to detail and accuracy.
- Excellent project management skills.
- Proficiency with standard medical writing software tools (e.g., EndNote, Reference Manager).
- Effective communication and interpersonal skills.
Qualifications
- Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD).
- Minimum of 5 years of experience in medical writing within the pharmaceutical or biotechnology industry.
- Proven experience with regulatory submissions and knowledge of FDA/EMEA regulations.
- Demonstrated ability to manage complex writing projects within a collaborative team environment.
- Strong understanding of statistical principles and clinical trial methodology.
- Excellent command of the English language and outstanding writing skills.
Responsibilities
- Lead the development and compilation of clinical study reports, protocols, and regulatory submission documents.
- Collaborate with clinical, regulatory, and marketing teams to ensure document content meets regulatory and company guidelines.
- Translate complex scientific concepts into clear, concise, and accurate content for a variety of target audiences.
- Participate in cross-functional teams to discuss and define data presentations and review statistical analysis plans.
- Review and edit scientific manuscripts for submission to peer-reviewed journals.
- Ensure that all documents are compliant with industry guidelines and best practices.
- Provide mentorship and guidance to junior medical writing staff.
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