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Job ID               0124
Job Location      Mountain View

Job Category     Clinical

Alexza Pharmaceuticals is a specialty pharmaceutical company located in Palo Alto, California. We are developing breakthrough therapies for the treatment of acute and intermittent medical conditions. Alexza was founded by Dr. Alejandro Zaffaroni who is one of the most successful entrepreneurs in the biomedical industry with a long list of successful start-ups to his credit, including ALZA, Affymax and Affymetrix Corporations.

We have an exciting opportunity for a Medical Writer. This person will work closely with our multi-disciplinary team of scientists and engineers who are dedicated to the development of novel drug delivery technologies with the potential to revolutionize the treatment of several common diseases.

Responsibilities:

• Writes manuscripts for publication based on clinical study reports, published literature, and other sources as required.
• Prepares draft abstracts and posters for submission to/presentations at scientific meetings.
• Serves as author of clinical sections of a large volume of regulatory and clinical documents (e.g., study reports) supporting clinical trials and product approvals, working independently with minimal direction, while ensuring appropriate and effective collaboration with key functional contributors.
• Acts as an internal consultant to R&D functional groups on the content and optimal presentation of regulatory documents to facilitate achievement of submission objectives and in accordance with regulatory document requirements / guidance.
• Assists with the development of Company training programs with respect to regulatory submission requirements and related processes. Spearheads group initiatives in relation to document standards, continuing MS template development, cross-functional processes and other aspects of document management (in collaboration with publishing group). Participates in other highly complex Company-wide initiatives

Skills required:

• Excellent medical writing and verbal communication skills
• Knowledgeable of document management, authoring and publishing tools and their applicability for workflow efficiency
• Knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe
• Must be organized, have the ability to successfully manage multiple projects, be able to work in a team environment, and communicate effectively in a fast-paced setting

Education and experience:

• Requires a BS or BA with 5+ years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions
• Demonstrated experience in the preparation of regulatory documents
• We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.

Alexza Pharmaceuticals is an Equal Opportunity Employer.

To apply:
http://www.alexza.com/careers/open.php