RA Strategic Medical Writer

Purpose Statement:
Prepare high-quality and accurate Japan-specific regulatory and clinical documents in accordance with regulatory requirements based on policies of Global R&D including Global SMW, and Japan Development.
Provide project management for all projects for assigned team.
Serve as local coordinator to streamline the communication between Japan project team and all global stakeholders including global medical writing team (Strategic Medical Writing [SMW]).
Liaison activities with medical writing vendor in Japan as needed regarding preparation of regulatory and clinical documents.
Major Responsibilities:
Provide effective leadership of assigned work to support smooth progress of each project in accordance with pharmaceutical regulations, SOPs, manuals, etc. Primary remit includes but is not limited to:
Briefing books including those for PMDA consultation/pre-meeting
Request form for PMDA consultation/premeeting
Responses to PMDA/MHLW for (s)NDA, PMDA consultation, and CTN, including being part of the Rapid Response Team (RRT)/Labeling Subteam (LST) Responses to Agency Questions including ad hoc requests including those for PMDA consultation/premeeting documentation
J-CTD Module 1 to include Japan package insert
Japan s(NDA) application form
Orphan Drug Designation request form, briefing book, application form
Sakigake Designation request form, briefing book, application form
Specific Use designation request form, briefing book, application form
Japan Package Insert Maintenance, including update of side effect sections, assessment description based on CCDS revision
Japan CTD updates during (s)NDA
Post-submission safety updates
Advise on the document structure and content based on medical writing industry best practices and experience in medical writing.
Formulate assignment plan and timeline for responsible cross-functional team members to each project, collecting the inputs from Japan project team and managing the project to completion.
Build cooperative relationships with all cross-functional stakeholders both local and global (Global R&D, Development TA, Data & Statistical Sciences, Global Regulatory Strategy, Global SMW, Clinical Sciences, Japan Project Team, TAG, JDSSG, vendors)
etc.) and effectively represent SMW at assigned meetings, as necessary.
Prepare/update appropriate procedures when using a medical writing vendor.
Ensure that appropriate quality control (QC) checks are performed on medical writing deliverables, as required. Ensure authoring and review with the electronic document management system.
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or PhD/MD degree is preferred.
At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including at least 2 years’ experience in medical writing.
Ability to communicate clinical data succinctly, clearly, and accurately in writing.
A good team player and good planner with proactive, accountable, and details-oriented mindset
Must have excellent fluency in both oral and written communication skills in both Japanese and English.
Excellent skill for operating Microsoft Office (Word, Excel) and Adobe Acrobat is preferred.

Employment type
Full-time

Work arrangement
Hybrid