Senior Medical Writer - Thinknicity

Position Description

Job Number: F2652

Job Title: Senior Medical Writer

Location: South San Francisco, CA

Job Type: Fulltime

Salary/Pay rate: Dependant on experience.

Contact Details:
· Jessica Gottstein
· (415) 247 7700.
· jessica@thinknicity.com

Eligibility Requirements
· Relocation expenses are not available for this position.
· No resumes from third party agencies representing their own candidates.
· Position cannot entertain candidates requiring visa-transfer or sponsorship.

Thank you.

Job Description:
· The Senior Medical Writer is responsible for writing, editing, and/or reviewing clinical documents including, but not limited to, clinical study reports, investigator’s brochures, integrated regulatory summary documents, protocols, and manuscripts.
· Create documents that effectively and clearly convey scientific data, ensuring that such documents comply with regulatory, journal or other guidelines in terms of content, structure, and style.
· Additional responsibilities include the following:
· Write high-quality clinical documents that support client goals and objectives.
· Identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers.
· Understand the key components / messages for regulatory submissions as embodied in FDA and ICH guidelines, for instance, the Clinical Expert Report and Clinical Overview components of the Common Technical Document.
· Keep current with therapeutic area(s) relevant to assigned projects.
· Use appropriate client stylistic conventions.
· Keep up-to-date on the software needed for this position.

Candidate Requirements
· Minimum of 5 years of industry experience as a medical writer; an undergraduate degree in a scientific discipline, pharmacy, or medicine is preferred; an advanced scientific degree is a plus.
· Knowledge of, or aptitude for understanding, medicine; familiarity with the drug development process and regulatory documentation.

How to Apply

Application Instructions / Send a Resume