Senior Medical Writing Specialist

Job Description

Job Description

Chipton Ross is seeking a Senior Medical Writing Specialist for a REMOTE contract opportunity. **3 Month Contract (could go longer)**
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 their 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).
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
ew 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 client 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.
REQUIREMENTS:
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)
o 5 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
EDUCATION:
o The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills.
WORK HOURS:
Full time
Company Description Chipton Ross, a leader in staffing Technical Engineering, Information Technology (IT), Industrial, Professional, and Administrative career opportunities throughout the United States. (Now offering a Logistics Recruiting Division.)
Visit our web site @

http://www.chiptonross.com/

to get details on over 2500 job openings in 28 states.

Company Description

Chipton Ross, a leader in staffing Technical Engineering, Information Technology (IT), Industrial, Professional, and Administrative career opportunities throughout the United States. (Now offering a Logistics Recruiting Division.) Visit our web site @ http://www.chiptonross.com/ to get details on over 2500 job openings in 28 states.
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