Sr. Medical Writer Position

Job Title: Sr Medical Writer

Location: Northridge , CA

Job Type: Permanent

Assume responsibility for an array of medical/technical documentation
activities associated with Clinical Research organization. The
qualified candidate will work directly with other medical/technical
writers and biostatistician to prepare, edit, and organize a variety
of technical documents that include presentations, manuscripts for
peer-reviewed publications, clinical evaluation report and study
protocols. Will also be responsible for educating members of the
Clinical Research staff in the area of effective visual and written
communication along with making sure that content contained in all
documentation conforms to company design control and legal
requirements. Will interface with Document Control, Research and
Development, Marketing, and Program Management where needed to ensure
the accuracy, timely review, and dissemination of all cross-
functional documentation.

Position Responsibilities

• Prepare, format, and submit summarizes data from clinical studies
for submission to the Food and Drug Administration (FDA).
• Coordinate, prepare, and submit abstracts for presentation at a
variety of annual diabetes meetings
• Review and edit protocol produced by members of the Clinical
Research staff.
• Collaborate with Document Control to development and implement
systems that ensure the timely release of technical documentation
• Work with internal and external resources to enhance the access of
relevant information to all Clinical Research staff. Efforts may lead
to the formation of a library type structure.
• Responsible for the following: Writing or substantively rewriting
investigator's brochures, final reports, papers for
scientific/medical journals, risk/benefit and integrated data
summaries, literature summaries, and position papers according to ICH
guidelnes.
• Working with project management to set timelines. Drives timelines
for projects.
• Ensuring high quality with regard to scientific content,
organization, clarity, accuracy, format, consistency, and adherence
to regulatory and internal guidelines.

Basic Qualifications

• Bachelor's Degree

• 3 years of medical writing work experience

• Candidates must be independent critical thinkers, deadline and
detail oriented, and able to manage multiple projects in a fast-paced
environment

• Proficiency in the use of technical publication tools

• Extensive knowledge of Microsoft Office and the ability to create
documents that seamlessly integrate spreadsheets, images, and text

• Verbal communication skills necessary communicate with an array of
technologists with widely varying backgrounds

• Ability to write technical summaries and articles for internal and
external publication

• Ability to present information to top management

• Ability to read, analyze, and interpret common scientific and
technical journals

Desired/Preferred Qualifications

BS in a scientific discipline

5 years of medical writing experience preferred

Previous experience within a Clinical Research or Regulatory
organization is preferred.

Understanding of diabetes and the medical device management of
diabetes

Be able to show examples of medical reports, papers, and documents
previously created
Contact:

Shanta Lama
Tel: 973-481-0100 Ext: 3069
Fax: 973-481-1020
shanta.lama@vernascientific.com
www.makrotech.com