Serves as a Senior Medical Writer on Clinical Study or Regulatory Project Teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.
Mentors and leads less experienced medical writers on complex projects, as necessary.
Acts as lead for assigned writing projects.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team providing review comments on draft and final documents.
Adheres to established regulatory standards, including but not limited to ICH－E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on－time and on－budget.
Performs on－line clinical literature searches, as applicable.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing.
The Medical Writing in Japan is part of APAC team.
There is only one Medical Writer and this person will retire soon that is why they are looking for a replacement.
This role will manage variety of projects （most likely APAC, US, EU）
Report line a Manager of Medical Writer in India, who then reports to an Associate Director of Medical Writing in the US.
The Medical Writing APAC team has about 10 members.
【必須（MUST）】Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree （Social Sciences, English or Communications, preferred） with relevant scientific and/or medical knowledge and expertise.
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team－oriented approach.
Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Please understand that only qualified candidates will be contacted. Thank you for your cooperation.