Senior Medical Writing Specialist REMOTE

Description:

The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce clinical documents which support the safety and efficacy of our products. 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 nonclinical 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 Client 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 trialrelated 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 onthejob experience in scientific/medical writing (e.g. clinical trial and regulatory documents) preferred but not mandatory.