Dendreon Corporation

Technical Writer (Contract)

Department: Research and Development

Description:

Dendreon Corporation is a publicly held biotechnology company developing therapeutic vaccines, monoclonal antibodies and small molecule candidates for the treatment of cancer and other diseases.

We are currently looking for a Contract Technical Writer for three to six months.

• Writes and edits documents for submission to regulatory agencies in support of Investigative New Drug and Biological License Applications; CMC sections, in particular.
• Writes and edits Standard Operating Procedures (SOPs), Technical Reports, Process Descriptions, Batch Records and related documents in support of moving developed processes into cGMP production and creating a design history file in support of regulatory submissions.
• Integrates various sources of information into a uniform style and language for regulatory compliance; this includes electronic submission formats.
• Assists in developing documentation for instructional, descriptive, reference and/or informational purposes.

Requirements:

• Candidates should have a degree in a scientific discipline with 3-5 years direct biopharmaceutical experience and the writing of technical documents in this industry.
• Prior experience within pharmaceutical manufacturing or CMC is a highly desirable. Any additional product development and process validation experience is also a plus.
• Candidate must be proficient in the MS Office Suite (with advanced skills to include creating linked table of contents, using cross-referencing tools, importing tables and figures, and easily adapting to customized corporate templates). Prior experience with Visio, Endnote and/or Adobe Acrobat 6.0 is also favorable.
• Candidate should possess strong organizational, stylistic, grammatical, and editorial skills with knowledge of advanced data presentation (tables, graphs, charts etc.), and experience guiding manuscripts through the entire publication process.
• Prior experience with the CTD and/or an NDA/BLA is preferable, but not required, as is experience with electronic documentation development and conversions.
• Essential to the position are the ability to work effectively in a fast-paced, dynamic environment; strong organization, communication, and analytical skills; excellent written and oral communication skills; impeccable accuracy and attention to detail; willingness to adapt as work evolves; results and goals oriented; and the ability to work in a team environment with minimal supervision.

The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Candidate should submit a cover letter, r‚sum‚ and two writing samples (i.e., oncology or biopharmaceutical, preferred, but at a minimum clearly demonstrating the ability to sufficiently explain a scientific technical principle to the lay population) of less than 250 words apiece.

We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. For consideration, please email your resume to:

Please include the job title and job #04510 in the subject line.

Dendreon Corporation
Reference Job Code: 04510
Attention Human Resources

Email: jobs@dendreon.com

Dendreon Corporation is an Equal Opportunity Employer

Submitted: 06/26/2004