Category Medical Science & Translational Research
Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market.
The Director, Medical Writing establishes strategies for document authoring, contributes strategically and scientifically at the project and/or study team level, manages internal/external medical writers for document quality, and develops medical writing timelines, processes, and working standards.
This can be a remote position.
- Directs internal/external medical writers responsible for writing and/or editing a variety of medical/clinical/safety/regulatory documents.
- D irects the medical writing team and writes key documents and/or oversees the writing of others.
- Facilitates and collaborates with internal and external stakeholders in support of clinical/regulatory/safety documentation objectives.
- Leads or contributes to process improvement initiatives.
- Position may independently serve as primary author of complex clinical documents and leads regulatory submission document development.
- Works with senior management to develop strategy and set direction for the function.
- Tracks and prioritizes writing projects and activities related to disclosure and transparency.
- Bachelor's degree is required.
- Advanced scientific degree (MS, PharmD, PhD) is preferred
- 10+ years of pharmaceutical or pharmaceutical Clinical Research Organization (CRO) regulatory medical writing experience. Well-documented, proven medical writing experience is preferred.
- Experience in a managerial or lead role, including project allocation. People management experience (managing medical writers) is preferred.
- Ability to draw on broad expertise to recommend new company SOPs (or revisions to existing ones) to continually improve internal processes.
- Outstanding team player. Can work as both a leader and a team member in a collaborative, supportive role; demonstrates leadership through assigning/managing the work of other writers and developing people through mentoring.
- Knowledge of clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH, NIH), AMA writing style, use of Word templates, and familiarity with GCP guidelines. An attentive, fast learner willing to continually build regulatory medical writing expertise and implement medical writer/MTDA working processes and SOPs.
- Outstanding interpersonal, written and oral communication skills; an ability to work in collaboration with a cross-functional study team and to establish rapport with all functional leaders, experts and colleagues.
- Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and nonclinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences.
- Ability to lead and/or contribute to the new or revised relevant company SOPs to continually improve internal processes.
- Ability to multitask while driving towards critical deadlines on all projects
- Superior attention to detail. Ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US- and UK-based English.
- Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions.
- Required to travel as needed though travel is likely infrequent.
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Posting ID: 564762657Posted: 2020-08-09