Location: Philadelphia,PA, USA
General Summary
The Associate Director, Advarra Consulting has the responsibility, as assigned, to serve in a team leadership role and operate as a client liaison and provide consultancy services as an individual or as part of an increasingly diverse consulting group for Advarra Consulting Client Projects.
The GXP Service Line generally includes Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), Good Pharmacovigilance Practice (GVP), collectively known as GXP. The Regulatory service line generally includes regulatory compliance, regulatory affairs, protocol development, and medical writing business opportunities in the human subject research market and broader life sciences field. Both service lines may also include Information Technology (IT), medical device and other support and may expand or change based on business needs.
The Associate Director operates as a client liaison and provides consultancy services as an individual contributor or as part of a larger team for Advarra Consulting Client Projects. The Associate Director professionally applies working knowledge and expertise in clinical research, quality assurance, regulatory affairs, research administration and other diverse areas, as assigned by the management team, to effectively manage services and project deliverables to Clients.
Primary Duties and Responsibilities
* Assisting the Senior Director/ Director in the oversight of Consulting Services provided to Clients
* Assisting in the supervision and allocation of resources relating to Client projects
* Providing training and oversight, and serve as a mentor to departmental staff members and independent sub-contractors
* Establishing, cultivating and maintaining relationships with specific clients as the primary point of contact for all service-related client communication and cross-project issues
* Maintain a goal of a billable utilization rate of approximately 50%
* Attend and participate in Management and Infrastructure Support Meetings
* Evaluate processes and gauge ongoing procedural compliance within Advarra Consulting and influence process improvement initiatives
* Represent Advarra Consulting on Business Development /Sales calls
* Advise on the development of departmental Standard Operating Procedures, Guidelines and other tools to support Client consulting services
* Performs other assignments as directed by the Advarra Consulting Management Team
* Position may require extensive travel, up to 50% at times
Job Requirement
Education
* Bachelor's degree, or equivalent, from an accredited college or university required
* Preferred: Degree in Nursing, Science, or related field (or equivalent)
Experience
* Minimum of ten (10) years of Quality Assurance and/or Clinical Research experience in pharmaceutical, biotech, medical device, and other life science industries
* Strong Quality Assurance management experience and knowledge in Clinical, Laboratory, Manufacturing, Pharmacovigilance (GxP) experience
* Three (3)+ years of management experience in a related field
Knowledge/Skills/Experience
* Working proficiency in Microsoft Office (Word, Excel and Power Point)
* Project management and team building skills
* Excellent organizational and time management skills
* Outstanding interpersonal, communication, and writing skills
* Ability to work independently; planning, organizing, scheduling and completing work within deadlines
* Attention to detail with a high level of accuracy
* Work remotely, within a self-provided, designated workspace which includes reliable internet connectivity
* General Working Conditions include, but are not limited to:
* Home or corporate office environment
* No physical demands;
* Domestic travel requirements (up to approximately 35%)
Physical and Mental Requirements:
* Sit or stand for extended periods of time at stationary work station
* Regularly carry, raise, and lower objects of up to 10 Lbs
* Focus and attention to tasks and responsibilities
* Verbal communication; listening and understanding, responding and speaking
EEO Statement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.
EEO/M/F/Disabled/Vets