(Onsite in Nashville)
A specialty pharmaceutical company that acquires, develops and commercializes branded prescription products designed to improve quality of care and address unmet medical needs.
Markets, including hospital acute care, Oncology and gastroenterology.
What you can expect to be doing…
- Assist in non-clinical, clinical, and regulatory responsibilities, primarily researching, coordinating, and drafting regulatory packages for new product candidates.
- Research, write, and edit nonclinical, clinical, and/or regulatory documents for submission to regulatory agencies (e.g., U.S. Food and Drug Administration) or for publication or presentation.
- Be responsible for authoring, compiling, reviewing, and submitting various industry documents such as but not limited to, INDs, NDAs and clinical protocols.
- Be responsible for implementation, planning, and execution of assigned clinical trial activities.
- Draft and assist with preparation of scientific and clinical information for IND and other submissions to FDA, related to both existing and new product candidates.
- Identify clinical and nonclinical research sites, design the needed study related documents and oversee their research activities.
- Independently lead, plan and execute trial activities for multiple non-clinical and clinical studies.
- Conduct and oversee activities related to data generation and validation, including Case Report Form design, clinical data review, query resolution to ensure high quality data.
- Assume responsibility for the activities and special projects as assigned in support of the company’s product development and regulatory initiatives.
What you will bring to the table:
- B.S. degree in Life Sciences required – Advance Medical/Scientific Degree preferred.
- 2+ years of experience in clinical research, science, or equivalent.
- Excellent verbal, written, communication and interpersonal skills
- Ability to assimilate technical information quickly
- Detail oriented, routinely takes initiative, strong sense of teamwork
- Proficient knowledge of relevant disease areas including, compounds under study (including MOA, PK/PD, biomarker & safety profile), indications and KOLs
- Proficient critical thinking, problem-solving, decision-making skills
- Adaptable / Flexible – willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism