Clinical Research Scientist

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