Job Description

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

Description

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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.
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Collaborate and Represent: Represent Medical Writing on clinical and cross-functional teams, lead document-related meetings, and review statistical analysis plans.
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Resource Planning & Submission Support: Estimate Medical Writing resource needs for supported programs and assist with market approval submissions under senior guidance.
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Quality Review: Review documents prepared by staff, contractors, or CROs to ensure clarity, consistency, adherence to standards, and high-quality language.
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Vendor and Global Coordination: Oversee vendor deliverable, set communication expectations, and collaborate closely with local and global clinical and regulatory teams.

Profile

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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.
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Regulatory and Submission Expertise: Proven ability to lead document strategy discussions for less complex programs and coordinate vendor resources for country-specific regulatory filings.
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Language and Communication Skills: High Fluency in English and Japanese (non-native level speakers are not selected)
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Technical Proficiency: Skilled in Microsoft Office, Word templates, Adobe Acrobat, document management systems, and familiar with SharePoint and structured content management concepts.
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Data Interpretation and Writing: Demonstrated ability to understand scientific data and represent it clearly and accurately in regulatory documents.
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Soft Skills and Adaptability: Strong time management, organizational skills, and the ability to collaborate under pressure. Effective presenter adaptable to different audiences.
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Professionalism and Compliance: Stays current with industry practices and regulatory guidelines, acts ethically, ensures quality, drives innovation, and is willing to travel when required.

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.

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