Senior Medical Writer
Role : Senior Medical Writer
Location : Remote role
Duration : Long Term
Essential Duties and Responsibilities :
- With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
- Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents / new drug applications / briefing documents per regulations, manuscripts / abstracts for publication and / or presentation.
- Ensure compliance of clinical documents with national and international regulatory requirements and guidelines.
- Work closely with cross functional team members and serve as MW representative at study team meetings.
- Prepare document timelines, with guidance from manager, as needed.
- Conduct literature searches.
- Develop deeper knowledge of specific therapeutic areas.
Qualifications :
- Experience in scientific and / or medical writing.
- Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
- Strong organizational skills and meticulous attention to detail.
- Familiarity with clinical trial-related and regulatory clinical submission templates and documents
- Ability to apply global regulatory authority regulations and / or guidance.
- Manage multiple projects with competing priorities.
- Experience working in a team environment (remotely) as well as independently.
- Medical statistics knowledge
- Proficient in Mircosoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams
Education and / or Experience :
The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills.
5 years of on-the-job experience in scientific / medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
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