Summer Internship 2023 R&D Medical Writer
The Medical Writer Intern will play a key role and participate in cross-functional clinical project teams. The Intern will support planning, preparing, and coordinating medical writing projects for Clinical Development. He / she will learn to mitigate risk associated with medical writing and disclosure processes by participating in the development and maintenance of medical writing and publication planning SOPs and Best Practices. In this internship role you will learn about the creation and maintenance of document / presentation templates and will gain responsibility for the assembly and quality control review of medical writing projects for Clinical Development.
Responsible for planning and preparing high quality medical writing deliverables that support the clinical development and regulatory requirements for Clinical Development.
1. Develops medical writing project timelines
2. Coordinates and manages the tasks, roles, responsibilities and timing of the authoring team and internal / external reviewers to facilitate document completion
3. Responsible for ensuring the appropriate plan, process and tools are in place for content editing, formatting, quality checking and publishing.
4. Maintains awareness of potential delays, problems or gaps of information that exist in the team effort of document preparation to effectively manage the process.
5. Coordinates the review, QC and assembly of medical writing deliverables.
6. Provides input into medical writing vendor selection, defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverable
7. Participates in the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high-quality medical writing deliverables.
The intern will learn an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
An undergraduate degree in pharmacy, biological sciences or related disciplines is essential, a preference for post-graduate qualifications desired (PhD or MD preferred)
• Good written communication skills, proficient with MS Word, detail oriented, good organizational skills.
• Editing, copy edit/proofread, formatting, check references and verify data content in documents, including manuscripts
• Assist Coordinating authors with the document development process (ie references, source documents, manage document for reviews, retention and Approvals)
• Edit check documents not Authored by Medical Writers
• Author sections of documents ie: Narratives
• Contribute to MW initiatives
• Become proficient with MW tools ie: PleaseReview, DocNet, Perfectid