Associate Scientific Regulatory Writing Director

Assoc Scientific Regulatory Writing Director page is loaded## Assoc Scientific Regulatory Writing Director locations:
Alameda, CAtime type:
Full time posted on:
Posted Todayjob requisition :
JR6365
** SUMMARY/JOB PURPOSE** **(Basic purpose of the job):
** Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross‑functional documents and reports as needed.
** ESSENTIAL DUTIES/RESPONSIBILITIES:
*** Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.
* Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.
* Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables.
* Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.
* Proposes and manages timelines for the document development process from initiation through approval.
* Oversees the assembly of appendices for regulatory submission documents as needed.
* Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.
* Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.
* Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.
* Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.
* Other duties as needed.
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* SUPERVISORY RESPONSIBILITIES:

*** No direct reports.
* Supervises work of junior writers and regulatory editors on document tasks.
* May direct and review the work of contract writers as needed.
* May mentor less experienced writers.
** EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

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* Education:

* BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or,
* MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or,
* PhD in related discipline and a minimum of five years of related experience including industry; or
* Equivalent combination of education and experience.
* Active AMWA member with certificate or certification preferred; BELS certification a plus.

Experience:

* Experience in Biotech/Pharmaceutical industry preferred.
* Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry.
* Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).
* Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.
* Familiarity with therapeutic area of oncology.
* Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards.
* Advanced knowledge of AMA style, medical terminology, and clinical data analysis.
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* Knowledge, Skills and Abilities:

*** Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.
* Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
* Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
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