The Lead, Medical Writing in collaboration with global medical writing team and China CPT is responsible for the creation of medical writing deliverables for China, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards.
The Lead, Medical Writing will be the lead author of regulatory and other scientific documentation, manage the overall collection of content from cross functional teams to produce documents according to ICH guidelines, company SOPs, and applicable local regulations and guidelines; be involved in strategic regulatory discussion during entire drug development process collaborating with China Reg Leads and/or CPT
;be the primary Medical Writing point of contact for China with global medical writing function
& manage the work and deliverables of China-based contract/vendor MW as needed
- Will ensure that clinical regulatory documents (e.g., study reports, study protocols, clinical summaries/overviews, contributions to response documents, and other China regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
- Will write briefing books, other strategic regulatory documents such as BTD requests, and participate in the preparation of responses to questions from regulatory agencies, assist with materials for presentations at agency meetings as needed.
- Will work independently to coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents, and ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
- Will maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs,
- Will manage the work and deliverables of contract/vendor writers, as needed
Qualifications：
- Master’s degree in life science discipline (Ph D preferred)
- 7-10 years’ experience of medical writing in global drug development including submission/approval and launch of new products
- Excellent verbal and written English written and communication skills
- Exceptional organizational skills and attention to detail
- Project management skills and familiarity with GCP and ICH guidelines.
- Technical skills with relevant software for authoring
- The ability to remain flexible should priorities change (judgment and decision making) during project execution.
- Able to work in multi-culture environment
- The ability to influence cross-functionally to improve procedures or practice as needed to remain within regulatory compliance and promote internal quality and efficiency
Able to mentor and manage work of vendors or junior writers as needed
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Job Level: Management
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
