As a key member of our Clinical Development Team, the Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums.
- Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical
and clinical studies. - Prepares clinical reports, summary documents, investigator's brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation.
- Works collaboratively, contributing to cross-functional teams and projects.
- Develops and drives detailed project timelines according to team-specified deadlines.
- Assists in the development of formats and guidelines for clinical documentation.
- May prepare scientific manuscripts, abstracts and posters.
- May also support clinical research associates and medical doctors in clinical protocol
development. - Proactively keeps abreast of professional information, trends and technology through conferences,
networking and other information sources and brings forward innovative ideas for consideration. - Perform other duties as assigned.
Qualifications- BA/BS required; preferably in a related scientific discipline.
- Advanced scientific degree (MS, Pharm D, PhD) is preferred.
- 2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (e.g., pharmacokinetic and toxicology summaries and investigator brochures).
- Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences.
- Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs.
- Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed.
- Strong project management skills; ability to multitask while driving towards critical deadlines on all
projects. - Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Excellent written/oral communication skills. Good interpersonal skills; able to establish rapport with all functional leaders, experts and colleagues.
- 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.
- Willingness to travel, though travel is likely infrequent.
Additional InformationOur Value Proposition:Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance / Supplemental Life Insurance/Dependent Life Insurance /Accidental Death & Dismemberment Insurance / Business Travel Accident Insurance / Short-Term Disability / Long-Term Disability / Flexible Spending Accounts / Employee's Savings Plan (401K Plan) / Competitive Paid Time Off
