Job Title: Sr. Medical Writer / Medical Manager
Location: Taipei, Taiwan
Report to: Head of Medical Writing (Beijing HQ)
Our client in this search is a global biopharma company focusing on developing immuno-oncology and molecularly targeted therapeutics. As the company is growing rapidly at commercial stage, they are seeking for a strong Regulatory Manager to input strategic decision making across APAC region and take charge of their new product registration in Taiwan.
Purpose of This Role
- Develop high-quality clinical documents (Phase 1 to Phase 4 globally or locally for China) timely for submission to regulatory authorities. Clinical regulatory documents, including but not limited to: clinical study protocols and amendments, investigator brochures, clinical study reports, regulatory briefing documents, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.
- Manage junior full-time employee (FTE) writers and/or external medical writers, as needed.
- Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
- Develop and manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
- Ensure clinical documents adhere to company standards and regulatory guidelines
- Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
- Ensure the key messages as defined by the team are clearly and adequately represented in the documents; drive the team to reach agreement in case of conflicting opinions.
- Establish effective cross-functional communication and relationships with counterparts both internally and externally.
- Participate in departmental or interdepartmental process improvement and training initiatives.
- Mentor and manage junior FTE writers as needed
- Minimum requirement of a master’s degree of life science/pharmacy/ nursing/medical/health related science or equivalent; PhD/PharmD in life sciences preferred
- At least 4 years of relevant industry experience as a regulatory medical writer
- Demonstrated ability to communicate and write English and Chinese clearly, concisely, and effectively
- Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands
- Independently motivated with good problem-solving ability
- Excellent interpersonal skills; a team player
- Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner
- Ability to comply with company and/or industry style guides and templates
- Strong project management skills
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems
- Experience in managing or mentoring junior FTE writers is a plus