Position Purpose:
The Senior Medical Writer is responsible for planning, preparing, and managing medical writing projects as well as creating and reviewing documents in some instances. The incumbent is responsible for the creation and maintenance of document / presentation templates, and is responsible for the assembly and quality control review of medical writing projects related to clinical development as well as regulatory submissions.
Reporting Relationships:
This role reports to the Head of Medical Writing Japan
Main Responsibilities and Accountabilities:
1 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
2 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
3 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
Position Qualifications and Experience Requirements:
Education
- An undergraduate degree in pharmacy, biological sciences or related disciplines is essential
- Post-graduate qualifications desired
Experience
- Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
- As a guide, a minimum of 5 years Clinical experience in the role of medical writer
- At least one experience as a lead writer for J-CTD
- An experience in developing clinical study reports in English is preferable.
Competencies
- A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development
- Excellent writing skills (clear and logical) in both English and Japanese
- Excellent written and oral communication skills in Japanese as well as business level communication skills in English
- Excellent interpersonal skills
- Excellent 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
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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