Medical Writer at Top Global Biopharma

Be part of one of the top global biopharma companies in the industry. Take lead in medical writing activities for the business.

Client Details

• One of the top global biopharma companies in the industry
• Specialising in oncology, immunology, immuno-oncology, and fertility
• Rich development pipeline with extensive patient-centric focused products/therapies
• Hybrid working style
• International working environment

Description

• Lead Document Preparation: Independently prepare or oversee the creation of key clinical and regulatory documents such as Clinical Summaries, Briefing Books, Protocols, Clinical Study Reports, and Investigator Brochures.

• Collaborate and Represent: Represent Medical Writing on clinical and cross-functional teams, lead document-related meetings, and review statistical analysis plans.

• Resource Planning & Submission Support: Estimate Medical Writing resource needs for supported programs and assist with market approval submissions under senior guidance.

• Quality Review: Review documents prepared by staff, contractors, or CROs to ensure clarity, consistency, adherence to standards, and high-quality language.

• Vendor and Global Coordination: Oversee vendor deliverable, set communication expectations, and collaborate closely with local and global clinical and regulatory teams.

Job Offer

• Competitive salaries and benefits
• Great work life balance
• Hybrid working style
• Amazing career progression in medical writing
• Work with industry leaders who are solving various unmet medical needs

Page Group Japan is acting as an Employment Agency in relation to this vacancy.

• Education and Experience: Bachelor's degree in a scientific or writing discipline required; Master's or PhD preferred. Medical writing experience in the pharmaceutical industry with scientific and regulatory knowledge.

• Regulatory and Submission Expertise: Proven ability to lead document strategy discussions for less complex programs and coordinate vendor resources for country-specific regulatory filings.

• Language and Communication Skills: High Fluency in English and Japanese (non-native level speakers are not selected)

• Technical Proficiency: Skilled in Microsoft Office, Word templates, Adobe Acrobat, document management systems, and familiar with SharePoint and structured content management concepts.

• Data Interpretation and Writing: Demonstrated ability to understand scientific data and represent it clearly and accurately in regulatory documents.

• Soft Skills and Adaptability: Strong time management, organizational skills, and the ability to collaborate under pressure. Effective presenter adaptable to different audiences.

• Professionalism and Compliance: Stays current with industry practices and regulatory guidelines, acts ethically, ensures quality, drives innovation, and is willing to travel when required.