Medical Writing Manager
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Scope
Contribute as a medical writer with primary expertise in clinical documentation while also supporting nonclinical sections as needed. This role leads and supports the development of regulatory documentsincluding CTD modules and briefing documentsand actively participates in strategic regulatory discussions throughout the drug development process from early development to JNDA submission and approval for Biogen programs.
Key Responsibilities:
- Lead the preparation of CTD Module 2 (clinical sections) Module 5 and relevant parts of Module 1.
- Lead the preparation of briefing documents (BDs) for PMDA consultations both informal and formal.
- Contribute to drafting response documents for PMDA inquiries during the approval review process and consultations.
- Support lead nonclinical writers in preparing documents such as CTDs BDs and PMDA response documents.
- Collaborate closely with global teams to obtain necessary information and crossfunctional support.
- Manage external vendors for document development including translation and editorial services.
Essential Skills and Qualifications Required:
- Strong experience in writing and reviewing clinical nonclinical and regulatory documents (e.g. protocols investigators brochures CSRs briefing documents CTDs).
- Demonstrated leadership skills to plan coordinate and drive document development.
- Ability to build effective teams that bring diverse opinions and perspectives.
- Broad understanding of clinical development beyond medical writing enabling contributions to Japan regulatory strategy.
- Strong writing proficiency in both English and Japanese.
- Proficiency with MS Word (including style templates) Adobe Acrobat and Documentumbased electronic document management systems.
- Strong communication problemsolving and timemanagement skills in both English and Japanese.
- Experience in vendor management.
- A proactive workstyle that incorporates emerging technologies including generative AI.
Education
- Life Science degree
Experience Requirements:
- Approximately 5 years of clinical medical writing experience in global drug development including new drug application approval and launch.
- Approximately 3 years of nonclinical writing experience in global drug development is preferred.
Why Biogen
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 onto learn more about our DE&I efforts.
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.
Required Experience:
Manager
Key Skills
- Anti Money Laundering
- Accomodation
- Compensation
- Instrument Maintenance
- Hotel Front Office
- Arabic
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
