[Remote] Associate Scientific Regulatory Writing Director

Note: The job is a remote job and is open to candidates in USA. Exelixis is a biotechnology company focused on developing innovative cancer therapies. The Associate Scientific Regulatory Writing Director will lead the content development for various regulatory and clinical documents, ensuring high-quality writing and adherence to regulatory standards throughout the asset development process.

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

Skills

• 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. 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
• 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. Engages internal stakeholders to establish productive collaborative relationships
• 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
• Experience in Biotech/Pharmaceutical industry preferred
• Active AMWA member with certificate or certification preferred; BELS certification a plus

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Receive long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year

Company Overview