Documentation Specialist For a Growing Biotechnology Company

SUMMARY:

 

Provide general clerical and administrative support to Clinical and Regulatory Affairs. An energetic, flexible team player with a positive attitude; willingness to go beyond the scope of the job to help the Company meet its objectives. Able to perform well under pressure and meet deadlines in a fast-paced environment. Ensure on time submission and approval of applications, amendments, and supplements. Maintain approved applications in compliance with appropriate statutes, regulations, and guidance. Coordinate with business, research, and operations professional staff to ensure generation and review of core regulatory and clinical documents.

 

DUTIES AND RESPONSIBILITIES:

 

Specific activities include, but not limited to the following: Generate a file inventory of all existing records (Master and Investigator Files) for Clinical Operations and Regulatory Affairs Establish a records management system for regulatory affairs and clinical operations Generate and maintain controlled copies, Standard Operating Procedures, Working Practice Documents, and tracking logs Formulate administrative strategy and tactics for all appropriate regulatory submissions (e.g., INDs, BLAs, MAAs,amendments, and supplements) for domestic, international, and/or contract projects Coordinate, prepare, and review all appropriate regulatory submissions (e.g. INDs, BLAs, MAAs, dossiers, amendments, and supplements) for domestic, international, and/or contract projects within a specified time frame in conjunction with the organization Follow Juvaris Safety, Health, and Environmental policies and procedures

 

JOB REQUIREMENTS:

 

Skills required in the following: Proficient in Microsoft Office applications (Outlook, Word, Excel, Project, Access, and PowerPoint) Prior pharmaceutical experience and knowledge of regulatory affairs and/or clinical operations Ability to maintain control of complex documentation systems under pressure Experience in creating procedures, work instructions and forms Able to perform well under pressure and deadlines in a fast-paced environment  Possess excellent judgment and analytical skills; strong verbal and written communication skills Excellent time management and organizational skills and able to manage multiple projects Professional appearance, attitude and demeanor

 

EDUCATION AND EXPERIENCE:

 

Bachelor’s degree in a scientific or healthcare discipline or equivalent combination of education and experience, with a minimum of 4 years administrative experience required.

 

COMPENSATION:

 

Salary base will be competitive with the field and experience.  Compensation package includes base salary, stock options, vacation time, sick leave, paid holidays and benefits.  Benefits include medical, dental, vision, life insurance, short-term and long-term disability insurance, flexible spending account plan and 401(k) plan.