Job Description
Kelly Science & Clinical ® is seeking an experienced Sr. Medical Writer for a short term contract with a Global Biotech Company.
Job Title: Sr. Medical Writer Specialist in Worldwide Medical Advanced Surgery Job Description: The Senior Medical Writing Specialist in Worldwide Medical Advanced Surgery will write and edit clinical documents to support regulatory submissions for relevant products. The ideal candidates must have a scientific background and be fluent in English both writing and speaking .
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 and Baxter procedures as applicable .
- 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, TeamsEducation 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
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Job Tags
Full time, Fixed term contract, Remote job, Worldwide,