International Project Manager Salary in Boise, ID

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™

Let Volt Help You Move ForwardVolt is immediately hiring for an Account Receivable Settlement Specialist in Dulutha, GA.As an Account Receivable Settlement Specialist, you will: Responsible for receiving, processing, and reconciling cash receipts daily, in multiple currencies across several different legal entities and bank accounts. Application and reconciliation of internal/external customer payments, including importation and application of cash batches, wires, and ACH payments. Minimize unapplied cash, over payments and short payments. Process physical checks received and resolve for returned checks Process credit card charges daily Upload and apply credit card payment files available Research unidentified/unapplied cash receipts and resolve issues in accounts receivable Process and service customer refund requests\ Assist with any unclaimed property reporting or processing as needed Build and maintain productive relationships with key external and internal customers (customer centric approach) to trouble shoot issues or inquiries Secure timely filing of cash batch back-up in a logical storage and retrieval system according to retention policy. Follow up with customer contacts for payment related questions and support documentation Balances multiple bank accounts to Subledger daily Prepare bank deposits daily Track daily cash receipts and coordinate wire transfer requests to Treasury Department Track and drive timely resolution of unidentified cash and liability exposure Understanding of Domestic and International payment systems, Wires, ACH payment processing to ensure that payments and settlements are processed in accordance with company policies and procedures (SOX) Meet performance metric goals established by management\ Assists with requests for annual audit and quarterly reviews Supports month end close process Perform ad-hoc analysis as assigned and other duties or projects as needed. This is a Full Time opportunity.Schedule: Monday - Friday: 8:00 am - 5:00 pm Hybrid - Monday, Tuesday, and Friday work remotely Wednesday and Thursday work in officeThe ideal candidate will have: Associate or bachelor's degree in Business or a related field preferred 3+ years' experience in Cash Application and/or accounts receivable. 3+ years of experience working with large corporate ERP such as JDE, Oracle and SAP High degree of comfort with numbers, and reconciliation of transactions and balances Awareness and understanding of SOX audit requirements in a publicly traded company Knowledge of MS Office Software applications, including Excel. Must exhibit advanced Excel skills Must be able to work independently with initiative in a fast-paced environment Excellent communication and interpersonal skills, with the ability to work with all levels of department management and with customers in a highly professional manner Strong understanding of Order to Cash transaction lifecycle Demonstrated extreme attention to detail and accuracy Pay Rate: $31.00 /Hourly *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short-term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please click here or call (866) -898-0005. Please indicate the specifics of the assistance needed.Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.Job ID : 427867