Create/revise medical related high quality documents such as common technical document (CTD) and clinical study report (CSR) in accordance with various regulatory guidance, and disclosing those documents as necessary as a department in charge of MW. To establish and maintain good relationships with relevant department in Pfizer throughout ‘Japan Medicin/Vaccine Team (JMT/JVT)’ activity, in order to improve the ability of writing skills by exchanging opinions  between different departments. 

For global simultaneous development projects, collaborate with Global Medical Writing Group, contribute to Global NDA submisions and submit for JNDA as soon as possible after US/EU NDA 

Furthermore, by supporting a line manager, trying to make all MW’s activities(including daily tasks) going more smoothly. 

Creating/revising CTD and CSR in accordance with the standard of process. In accordance with the related guidance and SOP, verify our documents meet the high quality standard (such as contents matche with original source documens and texts are logically described), and confirm that documents have no error or any mistakes. To establish and maintain good relationships with relevant departments in Global and Pfizer Japan in order to smoothly prepare documents and disclose documents for JMT/JVT activities and MW responsible projects. By means of discussing about review comments or descriptions of the documents, making an effort to improve  MW members’ writing skills. In response to the queries from PMDA, creating high standard of documents in order to reduce the time of PMDA review and gaining early drug approval. Create some part of PMS documents in accordance with the standard process. Drafting disclosure documents based on the latest CSR and CTD, and preparing the redacted CTD. In simultaneous development projects, contribute to create CTD for Global use and submit for JNDA as soon as possible from US/EU NDA. Handling appropriately (including writing) of publication, as required. Aiming to promote efficient work, maximizing use of outsourcing, sharing our knowledge and skills with outsourcing partners. By attending the activities of MW industry, making an effort to pfizer’s opinion able to reflect for drafting of MW-related guidelines.

  
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs