Senior Medical Writer eCTD NDA\ IND

Senior Medical Writer eCTD NDA\ IND

Round Lake, IL

Req ID 48803BR

Business Title
Senior Medical Writer- eCTD NDA/ IND

Business
Medical Products

Sub-Business
Research & Development

Country
US

State/Province
Illinois

Location of Position
Round Lake, IL

Shift_
1st

Job Description
The Medical Writer is responsible for the preparation of clinical regulatory documents, including NDAs/CTDs, INDs, briefing packages, annual reports, clinical study reports, and Investigator Brochures. This individual will contribute to clinical protocol development and will critically assess, interpret, and summarize data from Phase 1 through Phase 3 clinical studies for multiple products on a global level. He/She will collaborate with team members to develop and manage timelines for various sections of regulatory submissions. This individual will organize and manage multiple tasks related to the development of clinical regulatory documents and ensure that timelines are met and that documents are completed according to Baxter standards and processes. He/She will ensure consistency in documents within and across clinical programs by managing messages and developing and maintaining document standards. He/she will participate in SOP development and review, and be actively involved in the coaching/development of other team members (in-house and/or contractors). The individual will be responsible for creating posters and manuscripts as needed.

Job Requirements
Ideal applicants will possess outstanding written communication skills, a solid understanding of clinical data analysis, advanced knowledge of researching, writing, editing, and reviewing clinical documents, and a strong record of innovative problem-solving. Applicants must exhibit proficiency in teamwork, organization, project management, oversight of contractors, outstanding attention to detail, exceptional follow-through with assigned tasks, and self-motivation. Experience with electronic submissions and document templates is a plus.

Advanced degree (e.g. Masters, PharmD, PhD) is preferred with clinical pharmaceutical industry experience. A BS in a scientific field and 5-7 years of relevant work experience will be considered.

Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.