Training Specialist III (Clinical Research)

About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities• that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Description Title: Training Specialist III Location: MD, Gaithersburg - Corporate Headquarters Req: 01801 Position Summary: The Training Specialist III (TS III) position will support the Medical Organization Training and Standards Department (MOTSD) team in delivery of quality training services to the Medical Organization (MO). This position will provide for all MO Functional Areas comprising seven departments including Clinical Development, Clinical Operations, Product Leadership, Project Management, Medical Administration, Medical and Scientific Affairs, and Patient Safety. Responsibilities include: providing administrative assistance to on-boarding of new employees, Good Clinical Practice (GCP) training, core curriculum training, record documentation training, and the creating and developing job-related training (e.g., training concerning procedures, self-governance documents, technology/systems, etc.). The Training Specialist III responds to customer requests, both independently and as part of a team. The TS III manages increased responsibilities and works with limited supervision. S/he demonstrates attention to detail and to on-time delivery of MOTSD services. The Training Specialist III possesses a good working knowledge of the drug development process, key regulations and guidances that govern clinical research (e.g., Food and Drug Administration (FDA) Code of Federal Regulations (CFRs), International Conference on Harmonization (ICH) and European Union (EU) Directives, and other international standards. The TSIII is familiar with Good Clinical Practices (GCPs) and is able to offer training, as appropriate, related to applicable laws, statutes and statutory instruments, regulations, codes of practice, guidelines and/or policies V for countries in which MedImmune is conducting clinical trials and/or marketing products. S/he is experienced with problem solving, prioritizing, process mapping, and e-clinical technology. The TS III works in accordance with corporate best business practices, operational excellence initiatives, and compliance/quality assurance expectations. Position Requirements Major Duties and Responsibilities (including supervising others): The major duties and responsibilities of the Training Specialist III include but are not limited to: Provides team leadership, •hands-on direction, and guidance V adhering to project timelines, set milestone dates, and deliverables. Serves in the Training Liaison role providing deliverables and, when called upon, leads the team through the 5-step Operational Excellence (OE) process (DMAIC) to achieve specified goals. Assists MOTSD management in procedural document (MSP,SOP, etc.) development including design of related training and creation of Knowledge Assessments (KAs), drafting of computer-based training (CBTs), providing subject matter expert (SME) instructor-led training support, and facilitating of training events. Reaches out to customers to address identified needs in a positive, responsive, timely, and professional manner; handles promptly customer requests and, as necessary, forwards training requests and questions to MOTSD management; encourages Training Requests (TRs) and provides input into the development of Training Plan (TP) solutions. Participates in processing and fulfilling Training Requests/Training Plans for MO customers and recommends training solutions for GCP compliancy requirements, correction action plans, continuing improvement process ideas, and professional advancements. Works collaboratively with MOTSD team members, participating and supporting the completion of training initiatives. Designs, develops, and delivers training/education curricula comprised of MO corporate curriculum, job-related core curriculum, clinical trial conduct, technology/systems training, and drug development (e.g., FDA CFR, ICH, and GCP) topics. Participates in monthly departmental discussions and provides input regarding MOTSD objectives; collaborates in the planning, scheduling, and managing of assigned objectives. Represents, as requested, the MOTSD training-professional at meetings. Employs during the design, development and delivery of training V personal subject matter expertise, knowledge, and experience with regards to topics of clinical trial conduct and drug development (including FDA, OHRP, EU Directive, and ICH topics). Manages assigned goals and objectives for the Clinical Development and Operations (CDO) yearly operating plan that revolves around the following categories: o GCP Compliance o Controlled Documents and Procedural Training o Migrations & Upgrades o Design and Implementation o Vendor Selection & Management o Training Requests/Training Plans o Technology and Systems Training o Other Training Offerings Implements all training duties assigned by direct Supervisor and/or MOTSD Manager/Director. Educational Requirements Education: This position requires a Bachelors/Masters degree or equivalent in a life science, education or engineering discipline V preferred MS, MD or PhD in education or medicinal area. Experience: 5-7 years of clinical research experience in the pharmaceutical or biotechnology industry, showing progressive job growth and responsibilities. An industry professional certification is a plus. Prior project management experience is helpful. Special Skills/Abilities: Knowledge of FDA and OHRP regulations and guidelines, ICH guidelines, EU Directives is mandatory. Proficiency in use of Microsoft Office products (e.g., Word, Excel, PowerPoint, Visio, FrontPage, etc.), Articulate, and Lectora is requisite. Excellent interpersonal skills. Additional Information: Ability to function in a dynamic, growing, diverse and fast paced environment is a must. Personal flexibility to adjust to the needs of business is required. Personality ability to adapt rapidly to change is essential. Ability to support training activities V relating to business processes, technical systems and personal development V is critical. Ability to travel greater than 30% of the time for work commitments domestically and internationally is required. Job Complexity: Intermediate Supervision: Must be able to work independently and under direct supervision. Company Info None Specified

Please refer to job code 01801 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Clinical Research
Location:	Gaithersburg, MD
County:	Montgomery County
ZIP Code:	20877
Pay Rate:	Open
Job Terms:	full time
Company:	MedImmune Inc.
Phone:	email only please
Fax:	email only please