Regulatory Manager (Medical Writing) - F. Hoffmann-La Roche Gruppe : Job Details

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

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

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.