In PersonTravel up to 30% domestically and internationally is required.
About the job
Requirements
A minimum of 2–5 years of pharmaceutical industry clinical trial experience is required.
Primary experience with development of clinical trial protocols is required.
Medical or scientific writing experience and familiarity with clinically applied science or pharmaceutical development are required.
A good understanding of Food and Drug Administration regulatory, International Council for Harmonisation, and Good Clinical Practice requirements is required.
The candidate must be able to communicate effectively in writing and verbally and work across company disciplines and functional units.
The candidate must be able to manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high-quality, on-time deliverables are required.
Willingness to travel up to 30% domestically and internationally is required.
Responsibilities
Prepare clinical-related documents with minimal supervision and routine documents independently, including protocol synopses, protocols, case report forms, and supporting work for regulatory submissions such as Investigational New Drug applications.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Prepare, present, and defend complex aspects of protocol design and study data at investigator and internal meetings.
Oversee and coordinate the collection of pre-study documents and collect them when needed.
Participate in data review, discrepancy resolution, and team meetings and presentations with increasing independence, and support the Program Clinical Leader or senior management as needed.
Assist in managing regulatory safety reporting, including serious adverse event queries and follow-up, annual reports, and investigator brochures, and learn various databases.
Critically review and synthesize complex information from scientific and clinical literature.
Desired Qualifications
Experience in immunology or endocrinology therapeutic areas is a plus.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed.Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our 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