Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.
A posição
This Opportunity
* Be accountable for developing regulatory documents for submission to regulatory authorities under minimal guidance of line manager
* Applies scientific writing, data analysis, document and project management expertise
* Leads cross-functional teams in content preparation with stakeholder management practices
* Supports line manager on functional excellence of regulatory documentation and new technology adoption
Roles and Responsibilities
* Manages the preparation of regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs
* Acts as a key strategic partner for the cross-functional content contributors, and as a lead author who ensures content requirements are met and lean writing principles are followed
* Plans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
* Resolves issues, errors, or inconsistencies in data with contributors as appropriate
* Reviews document content for organization, clarity, grammar, scientific standards, consistency of content, data and messaging; resolves issues with cross-functional contributors; and ensures compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/within a clinical dossier
* Leads the review process, including leading/coordinating adjudication of review comments and incorporating review comments
* Ensures that documents are published in collaboration with Submission Team and that the document is approved by the single accountable signatory
* Obtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documents
* Participates as a member of key functional/cross-functional team(s), ensuring that teams adequately plan for document deliverables
* Actively contributes to best practices and continuous improvement initiatives and projects; represents the team in functional and cross-functional initiatives/projects when required
* Actively engage in the exploration of new technology in content generation and reuse.
* Actively pursues knowledge on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas
* Act as a mentor to new members/less experienced members of the writing team
Key Competencies
Regulatory and Drug Development Knowledge
* Understands global regulations and relevant ICH guidelines; understands China regulatory principles and requirements for submissions of regulatory dossiers to health authorities
* Understands the role and the practice of regulatory activities; and key activities in drug development and commercialization
* Understands non-clinical and clinical concepts from a broad range of disciplines and knowledge on regulatory, scientific & medical issues important to drug development, relevant products, and disease/therapeutic areas
* Understands how regulatory documentation strategies fit within the broader global and local business strategy and operations
Stakeholder Management
* Builds effective and enduring relationships internally and externally, and applies effective stakeholder management practices
* Thoroughly communicates the local needs to assure global partners/stakeholders understanding
* Establishes and maintains support from stakeholders and influences stakeholders for best solutions
Operational Excellence
* Demonstrated clear, high-quality scientific writing style in the English language
Change Management
* Accepts change as positive and adapts to changing conditions
* Departs from accepted group norms of thinking and behaving when necessary
* Demonstrates agility in changing environment
People and Leadership
* Addresses and resolves conflict by creating an atmosphere of openness and trust
* Works effectively with other people over whom he or she has no direct authority
* Be good at promoting an idea or vision and be able to influence without authority
* Strong project management and team facilitation skills
* Ability to independently analyze and synthesize data, and aptitude or proven ability to guide the work of others
* Superb written and oral communication skills
Who You are
Education/Qualifications
B.S. or above in Pharmacy, Medical, Biology or related field
Relevant working experience:
* > 6 years’ experience in MNC Pharma company, at least 4 years in medical/regulatory writing
* independent working
* capable of bilingual writing is a plus
Language and PC Skills:
Chinese (mother-tone level) and English (proficiency level)
Computer skill: word, excel, power-point
Quem nós somos
Um futuro mais saudável nos leva a inovar. Juntos, mais de 100 mil funcionários em todo o mundo se dedicam ao avanço da ciência, garantindo que todos tenham acesso à saúde hoje e nas próximas gerações. Nossos esforços resultam em mais de 26 milhões de pessoas tratadas com nossos medicamentos e mais de 30 bilhões de testes realizados usando nossos produtos de diagnóstico. Nós nos capacitamos para explorar novas possibilidades, promover a criatividade e manter as nossas ambições altas, para fornecer soluções de saúde que mudem a vida e causem um impacto global.
Vamos construir juntos um futuro mais saudável.
A Roche é um empregador que pratica políticas de igualdade de oportunidades.
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