You independently prepare or oversee the preparation of clinical and regulatory documents such Clinical Summary and overview documents, Briefing Books, response documents to Health Authorities, Protocols, Clinical Study Reports, and Investigator Brochures.
You estimate Medical Writing resource demands for the program(s) you support and may support submissions for market approval under the guidance of a Senior Principal Writer/Associate Director.
You represent the department on clinical teams; lead document-related meetings and review statistical analysis plans.
You perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on adherence to business objectives and company standards, as well as organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
You serve as subject matter expert representing Medical Writing on cross-functional teams.
You will closely collaborate with the local regulatory and clinical team in Japan and also with the respective global teams in R&D.
You will directly oversee work of vendors supporting program deliverables, set communication expectations with the vendor writer and have the ability to coordinate vendor resources.
Qualifications
Minimum requirement of a bachelor's degree in a scientific or writing discipline; Master’s Degree or PhD is preferred.
Minimum of 2 to 5 years of MW related experience in the pharmaceutical industry is required ideally combined with scientific and regulatory knowledge.
Ability to lead discussions on document strategy for less complex programs or country specific documents.
Ability to coordinate vendor resources for filings including country-specific submissions for market approval or label extension thorough knowledge of the drug development process with an understanding of strategy for regulatory submissions.
Fluent in both English and Japanese (oral and written).
Demonstrated ability to understand and represent data clearly in written text.
Strong communication skills (verbal, written and listening) with the ability to interpret and summarize complex data.
Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
Excellent time and priority management; ability to work collaborate and efficiently under pressure.
Strong presentation skills and adapting to a variety of audiences.
Ability to maintain familiarity with current industry practices, regulatory requirements, and guidelines that effect Medical Writing.
Showing innovation and ability to implement change. Strong organizational skills.
Acts ethically, ensures quality, and creates customer value. Ability to travel.
