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.

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 Microsoft 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. Education must be accredited.

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.

Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.