Regulatory Manager (Medical Writing)
Regulatory Manager (Medical Writing)
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Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
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
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Employment Type
Full-Time
