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Elsevier Inc. CompanyCaliforniaSenior Medical Writing Specialist
Chipton-RossRemote, CA- Full-time
- Remote
211228 - Senior Medical Writing Specialist Industry PRO Region Remote Work City Remote State IL Rate $DOE Duration 6 months Description
Chipton Ross is seeking Medicate Writing Specialist for a remote contract opportunity.
JOB SUMMARY :
The healthcare industry requires that our client 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 our client's Worldwide Medical Advanced Surgery sector 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).
RESPONSIBILITIES :
o 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.
o 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.
o Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable).
o Work closely with cross functional team members and serve as MW representative at study team meetings.
o Prepare document timelines, with guidance from manager, as needed.
o Conduct literature searches.
o Develop deeper knowledge of specific therapeutic areas.
Qualifications :
o Experience in scientific and / or medical writing.
o Experience in the analytical evaluation of scientific
data and written or oral presentation in a logical, clear, concise manner.
o Strong organizational skills and meticulous attention to detail.
o Familiarity with clinical trial-related and regulatory clinical submission templates and documents
o Ability to apply global regulatory authority regulations and / or guidance.
o Manage multiple projects with competing priorities.
o Experience working in a team environment (remotely) as well as independently.
o Medical statistics knowledge
o Proficient in Mircosoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams
Education and / or Experience :
o 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.
EDUCATION :
The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline
WORK HOURS :
First Shift, Full Time
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.