Client has an exciting pipeline and is filing an NDA. Exciting times!!
Summary
Manages development of, writes, and edits documents to support drug development. Such documents may include study protocols, informed consents, investigator brochures, clinical study reports, INDs/NDAs, study manuals, and posters/slide decks/manuscripts.
Essential Duties and Responsibilities
Oversees the writing, editing and formatting of various documents to support clinical development.
Manages compilation of the components of complex submissions.
Edits, rewrites, or otherwise prepares drafts of documents.
Integrates various sources of information into a uniform style and language for regulatory compliance.
Manages medical writing staff-both internal and contract writers/editors
Communicates with external vendors as needed.
Determines methods and procedures on new assignment
Experience
Typically requires a minimum of 15 years of related post-graduate experience and/or combination of experience and education/training:
BS/BA degree in related discipline and 11 years of related experience; or, MS/MA degree in related discipline and 9 years of related experience,
Or a PhD degree in related discipline and 6 years of related experience.
Experience and significant participation in the preparation of clinical documents for regulatory
submissions (eg, clinical protocols, IBs, INDs, NDAs, BLAs) within a biotechnology, pharmaceutical, or CRO environment is required.
Experience with electronic publishing (eCTD) is preferred
Experience working in large cross-functional teams within a matrixed environment is required.
Management experience required. Experience managing a medical writing group is preferred.
Certification (eg, AMWA, BELS) is beneficial.
Knowledge/Skills and Abilities
Excellent writing ability and strong editorial & formatting skills are required.
Proficient using Microsoft Office suite on a Windows platform.
Ability to incorporate diverse feedback into a high quality document.
Ability to lead and supervise the work of others, and to provide direction to subordinates, peers, or teams based on general policies and management guidance.
Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
Strong analytical and business communication skills.
Skilled using electronic literature tools to obtain reprints of abstracts and medical publications.
Familiarity with oncology drug development is a PLUS.
Contact
Bonnie Gothmann/Vice President, Executive Search
415-684-1960
bonnie@corpsearchjmi.com 
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