Senior Medical Writer

Senior Medical Writer

South San Francisco , CA

Full time

Writes and edits various documents to support Clinical Development. Such documents may include Study Protocols, Investigator Brochures, Clinical Study Reports, INDs/NDAs, study manuals, and posters/slide decks.
• Edits, rewrites, or otherwise prepares drafts of Clinical Protocols and Investigator Brochures, CSRs, INDs, etc.
• Compiles, analyzes, and summarizes data from other sources as needed.
• Manages compilation of the components of complex submissions.
• Communicates with external vendors as needed.
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Strong editorial & formatting skills are required.

SUPERVISORY RESPONSIBILITIES:
• May delegate to more junior writers or contract writers as needed

• Typically requires a minimum of 5 years of related post-graduate experience and/or combination of experience and education/training.
• Biotechnology/Pharmaceutical/CRO experience in oncology therapeutic development is preferred.


• Prior medical technical writing experience within the biotech/pharmaceutical/CRO realm.
• Experience and significant participation in preparation of clinical documents for regulatory submissions (eg, clinical protocols, IBs, INDs, NDAs, BLAs).
• Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications
• Excellent writing ability.
• Proficient in Microsoft Office suite.
• Ability to incorporate diverse feedback into a high quality document.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Determines methods and procedures on new assignments.  
• Has good general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
• Applies strong analytical and business communication skills.

• Familiarity with therapeutic area of Oncology desirable.

If you are interested and available kindly send me a MS Word Doc of my resume’ to [Click Here to Email Your Resumé]  

Thank you for your time

Best regards,
Sudha Parameswaran
Buxton Consulting
4637 Chabot Drive,#115
Pleasanton CA- 94588
Email: [Click Here to Email Your Resumé]