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Scientist/Manager/Director, Clinical Research – NDA

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Taro in USA
JOB TITLE: Scientist/Manager/Director, Clinical Research – NDA
REPORTS TO: Senior Director, Clinical
The Scientist/Manager/Director, Clinical Research-NDA is responsible for preparing documents for inclusion in IB, protocols, briefing documents and clinical/ nonclinical sections of pIND, IND, NDA, and CTD applications to Health Authorities. Participate in development planning for assigned compounds. Responsible for developing clinical strategy for Innovative 505b1 and 505b2 projects.
1. Prepare clinical and nonclinical sections of pIND, IND, NDA, and CTD applications to Health Authorities
2. Develop clinical strategy for Innovative 505b1 and 505b2 projects
3. Review of scientific literature and development summaries in support of nonclinical pharmacology, pharmacokinetics, and toxicology statements in pIND documents.
4. Work with clinical, regulatory consultants, KOL to ensure that the development of innovative projects is in line with modern pharmaceutical industry standards.
5. Participate in Innovative projects team meetings and assist the teams in resolving issues
6. Prepare clinical study synopses for pIND briefing packages
7. Prepare clinical sections of regulatory documents (IB, IP, IND annual reports, NDA sections)
8. Assist the study managers in the review of protocols for IND studies
9. Prepare abstract, manuscripts and presentation for Innovative projects team and external meetings.
10. Work with the study managers and other team members to ensure that the clinical trials progress according to the Investigational Plan.
11. Working with other relevant (internal and external) teams to prepare/review regulatory documents and submissions, including integrated summaries of efficacy and safety, registration dossiers, product monographs/package inserts, and responses to health authorities.
12. Follow internal guidelines for document preparation.
13. Prepare clinical documents for NDA submissions.
14. Participate in IND/NDA meeting with FDA.
1. Provide clinical expertise and support
2. Other duties/responsibilities as assigned.
3. Be an expert in FDA and ICH guidelines for the new drug development
1. Good understanding of the drug development process, GMP/GLP/GCP & ICH/FDA regulations and guidelines.
2. Advanced degree in biological/toxicological or related sciences (PhD, MD, or MS) with 3 to 7 years of professional clinical scientific research and writing experience.
3. Good researching skills and expertise in searching medical literature and databases for clinical and technical information.
4. Good technical scientific writing and verbal communication skills.
5. Familiar with a variety of the field’s concepts, practices, and procedures.
6. Familiarity with toxicology, in vivo animal studies, pharmacokinetics, discovery pharmacology, cell biology, and biochemistry.
7. Proficiency in use of Microsoft Word, Excel, and Adobe Acrobat.
8. Ability to work with multiple complex projects and within cross-functional teams.
9. Excellent interpersonal and verbal/written communication skills.
1. Full time in-house position.
2. Travel 5% to 10% of time.
3. Work with confidential and sensitive information.
4. Work under pressure of meeting time critical deadlines.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude Taro Pharmaceuticals from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
Taro Pharmaceuticals U.S.A., Inc. provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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