International Project Manager Salary in State of Wyoming, USA

Company DescriptionSGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.Job DescriptionField Personnel will safely conduct field and office tasks related to field research for which they have adequately been trained to complete. Training will be provided on a task-by-task basis by one of the supervisory personnel.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Safely perform specific duties associated with the conduct of trials as detailed in SGS Standard Operating Procedures (SOPs). These duties are briefly summarized below:Assist scientist in all aspects of trial initiation, layout, identification and seed processing. Plot maintenance, planting and cultivation under direction of Field Scientist or Farm Manager.Pollinations, Sampling and Field Data collection under direction of Field Scientist.Apply maintenance and test chemicals under the direction of field management.Maintain through knowledge of GLP requirements, regulatory guidelines, and SGS SOP's.Safely complete assigned duties according to applicable SOP's and training.At all times, comply with SGS Code of Integrity and Professional Conduct.Adheres to internal standards, policies and procedures.Performs other duties as assigned.QualificationsRequired:Must be actively pursuing a degree in an agriculture related field.LICENSES / CERTIFICATIONSDesired:sUAS Part 107 licensePesticide Applicator LicenseKNOWLEDGE / SKILLS / ABILITIESLanguage Skills: EnglishMathematical Skills: BasicReasoning Skills/Abilities: IntermediateComputer Skills: Basic Must be able to effectively operate farm equipment, such as tractors, cultivators, and sprayers, and experience with small plot field equipment preferred.Pesticide Applicator Licensed or the ability to acquire.Must be detail-oriented, well organized and able to work independently. Excellent communications skills required.Must be able to work safely in a fast paced environment.Ability to handle a variety of projects effectively, efficiently and with confidentialityMust be able to lift up to 50 pounds.Must be able to attend work regularly and dependably.TRAVELSome travel might be local or international.EQUIPMENTThis job operates in a professional office environment. This role routinely uses standard office equipment such as computers and phones.PHYSICAL DEMANDS OF THE JOBPhysical/Sensory Demands Frequency Requirements Stand Frequently Move or traverse FrequentlySit OccasionallyUse hands ConstantlyReach with hands and arms FrequentlyClimb or balance OccasionallyStoop, kneel, crouch or crawl FrequentlyTalk/hear FrequentlyTaste/Smell NoneLift/carry/push or pull Frequently Vision RequirementClose vision (clear vision at 20 inches/50 centimeters or less)Distance vision (clear vision at 20 feet/6 meters or more)Peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point)Depth perception (three-dimension vision, ability to judge distance and three-dimensional relationships)Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus)Ability to see colorWORK CONDITIONS / EXPOSURE TO ENVIRONMENTAL CONDITIONSLocation of the Job: Wyoming, IL, United StatesENVIRONMENTAL CONDITIONS REQUIREMENTSWet or humid (non-weather) conditions NoneWork near moving mechanical pats FrequentlyWork in high, precarious places NoneFumes or airborne particles NoneToxic or caustic chemicals OccasionallyOutdoor weather conditions FrequentlyExtreme cold (non-weather) NoneExtreme heat (non-weather) NoneRisk of electrical shock NoneWork with explosives NoneRisk of radiation NoneVibration NoneBio-hazard OccasionallyNoise LevelModerate noise (examples: business office with computers and printers, light traffic)Other Physical/Work Environmental Exposures:None#IND123Additional InformationSGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.Perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disabilityAll your information will be kept confidential according to EEO guidelines.Job Location

Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition. This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making. Essential Functions Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution Represent regulatory on cross-functional teams Process, interpret and provide recommendations for complex strategies Provide regulatory and technical expertise to cross-functional teams Critically review documentation for regulatory submissions and provide input for necessary revisions Develop and implement regulatory strategies for CMC aspects of drug development and registration Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration Serve as Liaison for third party service providers Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards Supports the professional development of regulatory staff through mentorship and guidance Present to upper management at required intervals and effectively communicate successes and challenges Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.) Requirements Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities. Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience. Two years of supervisory experience of direct reports required, matrix management experience preferred. In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices. Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority. Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports. Preparing for and executing Health Authority meetings. Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™

Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity (NCE) as well as products already in non-clinical and/or clinical studies. This position will have a secondary focus on existing marketed products or those obtained through acquisition. This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making. Essential Functions Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution Represent regulatory on cross-functional teams Process, interpret and provide recommendations for complex strategies Provide regulatory and technical expertise to cross-functional teams Critically review documentation for regulatory submissions and provide input for necessary revisions Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration Serve as Liaison for third party service providers Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards Supports the professional development of regulatory staff through mentorship and guidance Present to upper management at required intervals and effectively communicate successes and challenges Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.) Requirements Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience. Two years of supervisory experience of direct reports required, matrix management experience preferred. Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority. Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports. Preparing for and executing Health Authority meetings. Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™