Medical Writer, Japan

CSL•Ottawa, ON

14d

About The Position

The Senior Medical Writer is responsible for planning, preparing, and managing medical writing projects as well as creating and reviewing documents in some instances. Reporting to the Head of Clinical Development Japan, the Senior Medical Writer is responsible for the creation and maintenance of document/presentation templates, and the assembly and quality control review of medical writing projects related to clinical development as well as regulatory submissions.

Requirements

An undergraduate degree in pharmacy, biological sciences or related disciplines is essential
Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
A minimum of 5 years Clinical experience in the role of medical writer
At least one experience as a lead writer for J-CTD
Excellent writing and oral communication skills (clear and logical) in both English and Japanese
Strong interpersonal skills and time management skills
Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and templates
An excellent understanding of all aspects of ICH and J-GCP
An ability to analyze, interpret, and communicate data accurately and concisely
Ability to work independently and as a team member
Ability to work to deadlines while maintaining focus on details and quality
Demonstrated ability to work collaboratively; demonstrated negotiating skills and resourcefulness

Nice To Haves

post-graduate qualifications desired
Experience in developing clinical study reports in English is preferable
A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development

Responsibilities

Responsible for planning and preparing high quality medical writing deliverables that support the clinical development and regulatory requirements for Japan
Develops medical writing project timelines in collaboration with relevant functions and global counterparts
Responsible for ensuring the appropriate plan, process and tools are in place for content editing, formatting, quality checking, and publishing
Creates and reviews documents according to the plan
Coordinates the review, QC, and assembly of medical writing deliverables including appropriate measures for PMDA inspections
Provides input into medical writing vendor selection, defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables
In close collaboration with the global counterpart, make sure the Japan deliverables fully meet Japanese regulatory requirements and conventions
Participates in the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides, content guides, and relevant systems/tools to ensure efficient preparation of high quality medical writing deliverables
Proactively determines the needed changes to existing or creation of new guideline, standards, templates, and relevant systems/tools
Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of external networks
Provides expert medical writing support to other functions as appropriate
Manage vendors with respect to deliverable timelines, costs, and quality while keeping desirable relationships
Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship
Negotiate with partners to determine roles, responsibilities, processes and mutual expectations
Negotiate with partners to determine the timeline that will be used for document delivery