YOUR ROLE:

As the Associate Director of Medical Writing, you will play a crucial role in producing high-quality clinical documents that are essential for product approval and lifecycle management. The purpose of this role is to address the challenges of delivering clear and effective clinical documentation, thereby contributing to our mission of advancing healthcare solutions. This role is based in Japan, and we offer flexible remote work options up to two days a week. 

KEY ACCOUNTABILITIES

Under the supervision of the Director, your responsibilities will include:

• Manages Medical Writing staff (Expert Level 1-3) for a single therapeutic area or complex program.
• Ensures timely delivery of high-quality clinical documents (e.g., clinical study reports, clinical summaries, protocols) to support product approval and life cycle management.
• Ensures lean processes and skilled resources.
• Recruits, trains, leads, and develops talent.
• Proactively contributes to the development and implementation of Medical Writing best practices and improvements.
• Performs Principal Medical Writing activities as needed to backup and support staff to meet business demands including overseeing clinical and regulatory document deliverables.

PROJECT & PROCESS MANAGEMENT 

• Oversees Medical Writing therapeutic area deliverables 
• Prioritizes and organizes simultaneous projects 
• Develops innovative solutions 
• Leads change management efforts 

SCOPE OF PEOPLE RESPONSIBILITY 

Vendor Management:  
Ability to review and provide feedback to contract writers and ability to provide support to Director for vendor governance 

People Management:  

• Ability to hire, train, develop and lead 
• Defines objectives and evaluates performance  

COOPERATION 

Internal Communication: 

• Interacts with all levels of the organization across functions and for specific programs 
• Requires strong influencing and interpersonal skills 
• Interacts with teams and stakeholders on a continuous basis 
• Delivers training 

External Communication: 

• Attends external conferences 
• Recognized for medical writing expertise, leading working groups and/or delivering presentations to a broad audience 
• Manages vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices on medical writing 

WHO YOU ARE:

EDUCATION 

• Advanced degree in science or writing discipline
• Fluent in English with native Japanese language skills.

WORK EXPERIENCE

• Minimum of 5-8 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge. 

• Demonstrated people development and management skills.  Able to lead, coach, and train more junior team members within the function. Adeptness to work in a matrix environment of cultural diversity and in a global setting. 
• Extensive experience writing all types of clinical & regulatory documents for worldwide use. 
• Experience in leading teams to produce clinical regulatory submission documents, including CTD Module 2 summaries. Lead of at least two submissions with accountability for preparation of summary documents. 
• Demonstrated experience mentoring and managing the project work of other Medical Writers. 

• Experience in the Therapeutic area or program assigned. 

JOB-SPECIFIC COMPETENCIES & SKILLS

• Strong understanding of drug development, study design, and biostatistics. 

• Expert knowledge of international regulations, requirements, and guidelines associated with clinical regulatory document preparation and submissions.  Ability to advise and guide teams regarding compliance. 
• Excellent written and oral communications skills.   
• Effective influence and relationship management skills. 
• Ability to assess risks, solve problems, and make decisions on a therapeutic area or program level. 
• Must be highly motivated, able to work independently, and willing to accept and assume a leadership role. 
• Ability to motivate, inspire and develop teams.  
• Independently motivated, and good problem-solving ability. 
• Able to innovate for continued improvement and growth. 
• Strong project management skills, detail oriented, and ability to organize and prioritize simultaneous projects. 
• Able to work well with all levels of multicultural staff. 
• Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structure content management. 
• Strong presentation skills and adapting to a variety of audiences. 
• Acts ethically, ensues quality, and creates customer value. 
• Fluent in English (oral and written) – knowledge of an additional language might be beneficial. 
• Position requires both domestic and international travel up to 10% of time.