Medical Writing Specialist
A Medical Writing Specialist researches and writes scientific documents related to pharmaceuticals, medical devices, and clinical evaluation reports.
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Sample Job Descriptions for Medical Writing Specialist
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
A Medical Writing Specialist is responsible for creating scientific documentation related to clinical research and regulatory submission. This entry-level position will work under supervision to provide accurate and compliant documents that adhere to guidelines and standards.
Required Skills
- Understanding of medical terminology and concepts.
- Strong research and analytical skills.
- Basic knowledge of the drug development process and regulatory affairs.
- Proficient in writing clear and concise scientific documents.
- Ability to manage multiple projects simultaneously.
- Capability to work independently and as part of a team.
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or a related field.
- Knowledge of Good Clinical Practice (GCP) and regulatory guidelines in document writing.
- Ability to interpret and present clinical data and other complex information.
- Proficiency in Microsoft Office and document management systems.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
Responsibilities
- Assist in the preparation and writing of regulatory documents, clinical study reports, and other scientific literature.
- Perform literature searches and reviews to gather information for document content.
- Ensure the accuracy and completeness of data presented in documents.
- Participate in the development and maintenance of templates and standards for clinical documentation.
- Coordinate with cross-functional teams to obtain necessary information for document creation.
- Review and edit scientific manuscripts for clarity, grammar, and formatting.
- Adhere to document timelines and submission schedules.
Intermediate (2-5 years of experience)
Summary of the Role
As a Medical Writing Specialist, you will play a crucial role in communicating complex medical information in clear and compliant ways. You will be responsible for crafting scientific and regulatory documents that support clinical research, product approval, and marketing in the pharmaceutical or biotech industries.
Required Skills
- Strong writing and editing skills with attention to detail.
- Ability to interpret and present clinical data and other complex information.
- Proficient in the use of medical writing software and tools, such as EndNote and document management systems.
- Excellent project management skills to meet deadlines in a fast-paced environment.
- Good interpersonal skills and the ability to work collaboratively with a multidisciplinary team.
Qualifications
- Bachelor's degree in a life sciences or related field; Advanced degree (Master's or PhD) preferred.
- 2-5 years of experience in medical writing within the pharmaceutical or biotech industry.
- Solid understanding of the drug development process and regulatory requirements.
- Proven record of complex scientific information presentation in a clear and concise manner.
- Experience working with clinical trial data and understanding of statistical principles in clinical research.
Responsibilities
- Research, write, and edit clinical and regulatory documents, such as study protocols, study reports, investigator brochures, and submissions to regulatory authorities.
- Ensure that all documents are prepared in accordance with regulatory guidelines and meet company standards for accuracy and clarity.
- Collaborate with cross-functional teams including clinical research, regulatory affairs, and marketing to gather the necessary information for document preparation.
- Conduct thorough literature searches and reviews to extract and summarize relevant information for inclusion in documents.
- Participate in the creation of publication materials such as abstracts, posters, and manuscripts for scientific conferences and journals.
Senior (5+ years of experience)
Summary of the Role
A Medical Writing Specialist is responsible for the creation and revision of scientific documents related to drugs, biologics, and medical devices. They ensure that all documentation complies with regulatory, journal, or other guidelines in terms of content, format, and structure.
Required Skills
- Exceptional writing, editing, and communication skills in English.
- Ability to interpret and present clinical data and other complex information in a clear and concise manner.
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Proficient in Microsoft Office Suite and familiarity with medical writing software and tools.
- Excellent organizational and time-management skills.
- Ability to work independently and within a team environment to meet deadlines.
Qualifications
- Advanced degree (e.g., MD, PharmD, PhD) in life sciences, pharmacy, or related field.
- At least 5 years of experience in medical writing within the pharmaceutical industry.
- Strong understanding of FDA and ICH guidelines and regulations pertaining to scientific documentation.
- Proven track record of successful document submission and acceptance by regulatory agencies.
- Experience in leading cross-functional teams and project management.
- Experience with Electronic Document Management Systems (EDMS).
Responsibilities
- Collaborate with clinical, regulatory, and other pharmaceutical team members to plan, write, and review clinical study reports, protocols, and other FDA regulatory documents.
- Ensure the accurate translation of clinical study data into appropriate report formats for regulatory submissions.
- Provide expert advice on document design and structure, and lead the development of large, complex documents such as briefing books and regulatory submission dossiers.
- Stay updated with current industry best practices and regulatory requirements related to medical writing and documentation.
- Lead cross-functional document planning and review meetings, and coordinate with external medical writers as necessary.
- Develop and maintain templates for document standards and best practices to ensure consistency across all documentation.
- Engage with subject matter experts to ensure scientific and technical accuracy of documents.
- Manage document review cycles ensuring adherence to timelines and prompt resolution of comments.
- Provide mentoring and direction to junior medical writing staff.
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