Work Schedule

Other

Environmental Conditions

Office

Job Description

Summarized Purpose: Provides complex study reporting and other project services to department personnel. Compiles, coordinates, revises and finalizes appendix documents. Interacts with project teams within the company and in many cases direct contact with clients to ensure that all federally required documents are complete, accurate, and final according to local, national, or international regulatory authorities. Enforces timelines and ensures deliverables are met for project teams, and in some cases for the client. Essential Functions and Other Job Information: Essential Functions  Provides study reporting and project services to the team.  Compiles, organizes and publishes clinical study reports including appendices.  Supports document formatting and report publishing  .  Evaluates the compilation needs in relationship to the overall project timelines, quality & delivery.  Engages other project team members, functional units or management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery.  Maintains high level of expertise providing accurate and complete documents to ensure that materials sent to clients are of high quality and without error.  Assumes leadership for complex compilation projects as necessary; provides training and guidance to junior team members. Job Complexity Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations. Job Knowledge Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks. Supervision Received Normally receives little instruction on daily work, general instructions on newly introduced assignments. Business Relationships Contacts are frequent with individuals representing other departments, and / or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function, or the department, or which may be of sensitive nature. Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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:  Good understanding of FDA and ICH guidelines  Strong understanding of clinical research, and/or regulatory environment  Capable of balancing client standards and company procedures with regulatory requirements  Strong grammatical and communication skills, both written and oral including English grammar  Strong software skills, including but not limited to Microsoft Word, Excel, and Adobe Acrobat  Solid problem-solving capabilities and organizational skills  Capable of independently performing numerous tasks simultaneously without losing sight of overall objectives  Adaptable to changes in work duties, responsibilities, and requirements  Capable of working independently as well as part of a team  Strong editorial and proofreading skills  Thorough knowledge of medical terminology  Familiarity with regulatory documents Management Role: No management responsibility Working Conditions and Environment:  Work is performed in an office or clinical environment with exposure to electrical office equipment.  Occasional drives to site locations. Potential Occasional travel required. Physical Requirements:  Frequently stationary for 4-6 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Occasional mobility required.  Occasional crouching, stooping, 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.  May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.  Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.  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 multi-task.  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.