Sr. Medical Writer

Sr. Medical Writer
Permanent - Taipei

Job details

  • City : Taipei
  • Function : R&D/Science
  • Sector : Pharmaceuticals
  • Reference : 28578

Job description

Job Title: Sr. Medical Writer / Medical Manager

Location: Taipei, Taiwan

Report to: Head of Medical Writing (Beijing HQ)

About Client

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.

Major Responsibilities

  • 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

Desired Qualifications

  • 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

Desired profile