Shire Veteran Jobs

Job Description

Summarized Purpose: Coordinates contracted safety responsibilities for one or more programs, including training, and procedural compliance. Works with managers and senior management, and develops consistent internal processes and ensures compliance with established processes. Provides plans and accurate forecasts for all projects. Proactively liaises with clients and ensures optimal performance and utilization of the safety project team. Essential Functions and Other Job Information: Essential Functions  Manages all aspects of multiple projects, both local and globally, ensures contractual, procedural and regulatory requirements are met. This may include serving as back-up for project coverage when needed.  Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement.  Reviews regulatory/(No Suggestions) publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.  Serves as a resource to other departmental managers.  May assist with preparation and presentation of proposals. Job Complexity Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Job Knowledge Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau. Supervision Received Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Business Relationships Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:  Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff• Strong knowledge of relevant therapeutic areas as required for processing AEs  General understanding of pathophysiology and the disease process  Time management and project management skills  Proficient in Microsoft Office products (including Outlook, Word, and Excel) and safety databases  Good command of English and ability to translate information into local language where required  Excellent oral and written communication skills including paraphrasing skills  Strong attention to detail and accuracy  Strong critical thinking, problem solving and decision making skills  Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents Management Role: No management responsibility Working Conditions and Environment:  Work is performed in an office/ laboratory and/or a clinical environment.  Exposure to biological fluids with potential exposure to infectious organisms.  Exposure to electrical office equipment.  Personal protective equipment required such as protective eyewear, garments and gloves. Physical Requirements:  Ability to work in an upright and /or stationary position for 6-8 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Frequent mobility required.  Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.  Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.  Ability to access and use a variety of computer software developed both in-house and off-the-shelf.  Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  Frequently interacts with others to obtain or relate information to diverse groups.  Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.  Regular and consistent attendance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.