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Exelixis · 1 day ago

Associate Scientific Regulatory Writing Director

Alameda, CA

Full-time

Onsite

Lead/Staff, Director/Executive

$148K/yr - $210K/yr

5+ years exp

Exelixis is a biotechnology company focused on developing innovative cancer therapies. The Associate Scientific Regulatory Writing Director will lead the content development for regulatory and clinical documents, ensuring high quality and compliance throughout the asset development process.

BiotechnologyHealth CarePharmaceutical

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

Qualification

Regulatory writing experienceBiotech/Pharmaceutical experienceDocument development leadershipAMWA certificationBELS certificationClinical data analysisDrug developmentInterpersonal skillsEffective communicationProblem-solving skills

Required

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 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

Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results

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

Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution

Manages effectively performing teams to achieve common objectives

Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems

Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives

Capable of managing the execution of multiple tasks

Ensures appropriate prioritization and execution for area of responsibility

Proactively anticipates, prioritizes and resolves task-related challenges

Designs and implements solutions to address task-related challenges, taking into consideration the broader impact