[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.ResponsibilitiesIndependently 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 audienceIncorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracyCompiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tablesAssigns and supervises partner regulatory editors for all document tasks unrelated to writingProposes and manages timelines for the document development process from initiation through approvalOversees the assembly of appendices for regulatory submission documents as neededServes as the primary writing contact on regular and ad hoc study/program/asset or project teamsProvides writing guidance to internal teams based on organizational goals and company policy, with responsibility for resultsPeer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team membersContributes to SOP and work instruction development and review for the Regulatory Science Communications teamOther duties as neededSkillsBS/BA degree in related discipline and a minimum of eleven years of related experience including industry; orMS/MA degree in related discipline and a minimum of nine years of related experience including industry; orPhD in related discipline and a minimum of five years of related experience including industry; orEquivalent combination of education and experienceActive AMWA member with certificate or certification preferred; BELS certification a plusExperience in Biotech/Pharmaceutical industry preferredPrior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industryExperience 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 publicationsFamiliarity with therapeutic area of oncologyAdvanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standardsAdvanced knowledge of AMA style, medical terminology, and clinical data analysisDevelops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality workApplies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex workDemonstrates 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 colleaguesStrong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolutionManages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationshipsApplies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problemsLeads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectivesCapable of managing the execution of multiple tasksEnsures appropriate prioritization and execution for area of responsibilityProactively anticipates, prioritizes and resolves task-related challengesDesigns and implements solutions to address task-related challenges, taking into consideration the broader impactExperience in Biotech/Pharmaceutical industry preferredActive AMWA member with certificate or certification preferred; BELS certification a plusBenefits401k plan with generous company contributionsGroup medical, dental and vision coverageLife and disability insuranceFlexible spending accountsDiscretionary annual bonus programSales-based incentive planOpportunity to purchase company stockReceive long-term incentives15 accrued vacation days in their first year17 paid holidays including a company-wide winter shutdown in DecemberUp to 10 sick days throughout the calendar yearCompany OverviewExelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases. It was founded in 1994, and is headquartered in Alameda, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.exelixis.com.