---: Collecting all the Life Science jobs for the Washington, DC metro area :---

Friday, September 19, 2008

Scientific/Medical Writer

Intercell USA, Inc. / IOMAI

Location: Gaithersburg, Maryland-Montgomery County 20878
Posted on: 1:09 PM, Thursday, September 18, 2008
Position type: Full time
Job Code: 080131
Required education: Bachelor's Degree
Area(s) of expertise desired: Clinical Research, Medical Writing, Regulatory Affairs

Description
Intercell AG, a Vienna-based biotechnology company, is committed to the discovery and development of innovative immunological products and technologies for the prevention and treatment of infectious diseases.

Intercell USA, Inc., a subsidiary of Intercell AG, located in Gaithersburg, Maryland, USA, is currently seeking talented, motivated professionals that will thrive in our highly productive, results-oriented and collaborative culture.

This position will be under minimal supervision and with the help of clinical department staff, the writer summarizes and present study data and writes checks study reports for accuracy.

Essential duties and responsibilities include the following:
. Write and critically review CSRs;
. Ensure that CSRs accurately reflect the data presented in the statistical tables and listings and other information sources for the CSR;
. Together with medical writing staff, manage the CSR review and approval process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed;
. Critically assess, interpret, and summarize scientific and statistical data for continuity within and across programs;
. Prepare documents for moderate to complex clinical trials including study protocols, informed consent forms, investigator's brochures, including updates and amendments;
. Ensure timely preparation of submissions and full compliance with applicable regulations;
. Collaborate with staff to collect and compile data from multiple sources into documents critical to clinical programs;
. Collaborate with team members to develop and manage timelines for clinical documents and sections, and;
. Perform other assignments or projects as needed.


Requirements .
. Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience
. Requires a minimum of 3 years experience in writing medical and/or technical documentation and manuals in a clinical research or drug development environment (examples include clinical study reports, investigator's brochures, INDs, NDAs, research grant proposals, protocols, journal articles, abstracts).
. Experience with regulatory submissions presented to regulatory authorities a plus, specifically concerning clinical study reports
. Must have working knowledge of FDA and ICH guidelines, as well as GCP and other standards.
. Requires excellent writing skills, interpersonal communication skills, and the ability to independently coordinate and prioritize multiple projects
. Should have experience in data analysis and presentation, statistical analysis, as well as quality control of representative data analyses/displays against raw data
. Should be proficient with MS Office (including Word and Excel), Adobe Acrobat and have a general understanding of statistical concepts and database use.

The successful candidate should be self-motivated, flexible, creative, able to prioritize and multi-task, and able to work in a fast-paced and demanding environment. He/she must think independently, solve problems proactively, and function well as a collaborative team member.

(Local candidate strongly preferred; applicant must provide writing samples that demonstrate ability to describe procedures and present and explain results)

We are an Equal Opportunity Employer with competitive compensation and benefits, including equity participation in the company. If you are qualified and interested, please forward your cover letter with position title and JOB ID # along with resume to the Human Resource Department.


IomaiHR@iomai.com
The above e-mail address is for
JOB APPLICANTS ONLY
.
For any other information please contact Iomai at (301) 556-4500 (press #3 for Human Resources)

Recent Offsite DC Metro BioJobs