ProPharma Group

Title: Director, Purchasing Location: United States Remote Full time Job Description: For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. ​The Director, Purchasing will provide strategic leadership and oversee the centralization of the purchasing function. This role is responsible for developing and executing short - and long -term sourcing strategies to improve operational performance, ensure cost efficiency, and main tain a competitive advantage through the procurement of capital assets, direct and indirect materials, and services supporting global operation Essential Functions : - Lead and manage the company’s purchasing organization. - Develop and execute purchasing strategies aligned with business objectives. - Ensure compliance with vendor, purchasing, and logistics goals; adjust strategies as needed. - Build and maintain strong external partner relationships. - Drive cost savings through innovation and operational efficiencies. - Maximize spend leverage on select direct materials to achieve significant savings. - Provide strategic vision and thought leadership to support organizational goals. - Oversee daily purchasing operations, including account alignment and roadmap execution. - Perform other duties as assigned. Necessary Skills and Abilities: - Expertise in designing and implementing purchasing processes and systems. - Ability to leverage technology for scalable, efficient solutions. - Strong understanding of contractual obligations and risk mitigation. - Skilled in issue resolution and escalation management. - Proven change leader with the ability to drive strategic transformation. - Analytical problem -solver capable of breaking down complex challenges. - Motivational leader who fosters engagement and enthusiasm. - Highly collaborative with strong influence and communication skills across diverse stakeholders. - Solid knowledge of corporate governance principles and requirements. - Proficient in negotiating and implementing Master Services Agreements, including innovative pricing and resourcing models. - Ability to manage multiple programs and priorities simultaneously. - Excellent interpersonal, organizational, presentation, and communication skills. Educational Requirements: - A Bachelor’s degree in Business or similar is required, advanced degree preferred. Experience Requirements: - Minimum 15 years of purchasing and supply chain management experience, preferably in the clinical or pharmaceutical industry. - Demonstrated success in building strategic, mutually beneficial supplier partnerships with both a strategic and hands -on approach. - Proven ability to lead and implement change management initiatives. - Deep knowledge of outsourcing cost drivers, resourcing and costing models, with experience in contracts and/or accounting. #LI-JH1#LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

Title: Director, Regulatory Affairs CMC Location: United States Job Description: For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne’s development programs, from early-stage development through commercialization and post-approval lifecycle management. This individual will serve as a strategic leader and subject matter expert (SME), ensuring high-quality, compliant, and globally aligned CMC regulatory submissions. The role will partner closely with Manufacturing, Quality, Clinical Operations, and Program Teams to support clinical registration, commercial readiness, and ongoing regulatory compliance. The position requires a highly experienced regulatory professional capable of operating independently, influencing cross-functional stakeholders, and driving complex regulatory strategies while meeting critical timelines in a fast-paced, dynamic biotech environment. Primary Responsibilities Include: - Lead and execute global CMC regulatory strategies across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle activities - Provide strategic regulatory guidance to Manufacturing and Quality teams to ensure global compliance and readiness for clinical and commercial supply - Oversee the planning, development, and delivery of CMC sections for global regulatory submissions, including responses to Health Authority (HA) questions - Manage regulatory activities related to clinical and commercial manufacturing changes, ensuring alignment with global requirements - Ensure CMC regulatory content aligns with evolving regulatory expectations, guidance, and policy trends across regions - Coordinate global submissions, product registration maintenance, and change control activities throughout the product lifecycle - Partner cross-functionally with Manufacturing, Quality, Clinical Operations, and Program Teams to deliver key regulatory milestones - Proactively identify regulatory risks and develop mitigation strategies to support program success - Leverage deep regulatory expertise to anticipate challenges and drive effective, forward-looking solutions - Contribute to organizational regulatory knowledge by sharing insights, lessons learned, and best practices Education and Skills Requirements: - Bachelor’s degree in Life Sciences or a related scientific discipline required; advanced degree (MS/PhD) preferred - Minimum of 10+ years of experience in biotechnology or pharmaceutical industry, including at least 7+ years in Regulatory Affairs with strong focus on CMC - Demonstrated experience leading CMC sections of global regulatory submissions, including biologics marketing applications (BLA/MAA) - Strong experience supporting global regulatory filings and health authority interactions (e.g., FDA, EMA, and other international agencies) - Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management - Strong working knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks - Experience with EU and international regulatory requirements for both clinical and commercial programs is preferred - Extensive experience with CTD structure, content, and global submission requirements - Proven ability to independently manage multiple complex regulatory programs in a fast-paced environment - Strong strategic thinking and problem-solving skills, with the ability to balance scientific, operational, and regulatory considerations - Excellent written and verbal communication skills, including regulatory writing and executive-level communication - Demonstrated ability to influence cross-functional stakeholders and senior leadership without direct authority - High level of attention to detail with strong commitment to quality and compliance - Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities - Ability to work independently and operate in a highly autonomous manner with minimal oversight - Candidates must demonstrate recent, hands-on experience supporting CMC regulatory activities within regulated life sciences environments Engagement Details: - Contract Duration: 12-month contract with potential for extension based on performance and business needs - Engagement Type: Full-time contractor (FTE-equivalent) - Time Zone Required: EST hours - Location / Delivery Model: Primarily remote, with potential for occasional on-site presence in Waltham, MA as needed - Travel: May be required for end-user training and key project phases We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Title: FSP Site Contract Specialist Location: United States time type Full time hybrid job requisition id JR 9604 Job Description: For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Senior Clinical Contract and Budget Specialist position is responsible for administering and negotiating site contracts that support clinical trial set up and execution on a global level. This role will ensure site contract documentation follows sponsor and ProPharma requirements, will work with internal and external team members to implement solutions for project and / or individual site contract related problems, establish strong working relationships with customers, internal project teams and sites, and ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/ Sponsor requirements. Essential Functions - Administer all contract management processes from start of document draft, through final document completion, negotiations, agreement, and signatures. - Support agreement on country template contract and budget. Assist in producing site-specific contracts from country template as appropriate. - Lead negotiations of budget and contract with site and with inclusion of cross functional teams as appropriate. - Lead with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. - Lead the reviews of contracts for completeness and accuracy and ensure that corrections are appropriately made and documented. - Assist cross functional teams with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues as per agreed roles and responsibility matrix. - Provide and generate (amended) contract and / or budget documents as necessary, prepare contract management documentation for projects, and streamline the contract / proposal or internal processes; initiate and introduce creative ideas and solutions. - Work within the forecasted country / site contracting timelines, ensure they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time. - Collaborate with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues. - Facilitate the execution of contracts by company signatories. - Support the development and maintenance of contract templates and site-specific files as appropriate. - Provide functional guidance and keep internal and external teams aware of all contract statuses or pending issues. Prepare correspondence as necessary. - Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP / Sponsor requirements. - Develop and review Confidentiality Disclosure Agreements (CDA) per study scope. Liaise and negotiate with sites and clients to fully execute the agreement. - Develop Clinical Trial Agreement and Budget grid templates as needed per study scope. - Utilize Grants Manager or equivalent internal systems to generate site budget templates per Fair Market Value parameters. - Assist the Director, Clinical Operations in developing workflows, Work Instructions, drafting SOPs (as a subject matter expert) for the Clinical Contract and Budget Specialist role. - Deliver any site-by-site client facing updates on the contract status / amendments during study start up or during the maintenance period. - Required to join client calls as outlined in the project budget or join any ad hoc calls pertaining to contracts & budgets status if the need is warranted. - Other duties as assigned. Necessary Skills and Abilities: - Ability to understand, explain and communicate contract concepts and put into detailed plans for progressing activities. - Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, encourage, and motivate. - Excellent verbal, written, presentation and communication skills are desired. - Knowledge of FDA and / or applicable regional regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials. Educational Requirements: - Bachelor’s Degree or International equivalent. - Advanced degree / Paralegal and / or Law Degree a plus. Experience Requirements: - Minimum 5-8 years’ Experience working with site and budget contracts. - Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. #LI-JH1 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

Title: Global Audit Coordinator Location: United States Job Description: For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Audit Coordinator is responsible for working directly with the Global Audit Coordination, Sr. Manager to primarily monitor and manage the Quality & Compliance Audit Program. This position works closely with Project Managers and Project Sponsors, generating documents, proactively tracking, and reporting, and providing administrative and clerical support as needed. Essential Functions: - Take primary responsibility for Audit Coordination and related activities, and to effectively support, Global Audit Coordination, Senior Manager, Project Managers and Sponsors according to current ProPharma best practices. - Effectively and proactively communicate with Project Managers and Sponsors, regarding contract documents, proposals, assignment letters, purchase orders, change orders and other contract modifications. - Responsible for generation of documents including contract documents (NDA/CDA), proposals, change orders, affiliate agreements and assignment letters. - Responsible for audit setup in DOT and Workday, support, time and expense review and approval, and invoice review and approval. - Be an active participant in the Project Management of large audit projects. - Develop, generate and/or maintain audit/project reports including the audit tracking log, personnel plan and utilization reports. - Ensure all correct documentation is in place prior to the commencement of the project in accordance with SOPs and or client training requirements. - Assist Global Audit Coordination, Senior Manager, , Project Managers and Sponsors with specific project reporting needs. - Other duties as assigned. Necessary Skills and Abilities: - Proficient computer knowledge and computer keyboarding skills including intermediate proficiency in Microsoft Office Suite to create client documents and reports. - Intermediate database skills to enter and retrieve information from multiple databases including ProPharma CRM and ProPharma Accounting/Project Management software. - Flexibility and adaptability to meet changing needs of the group. - Strong verbal, written and interpersonal communication skills. - Strong organization and prioritization skills; with strong attention to detail. - Ability to work independently and within a team. - Detail oriented to create documents and reports. - Able to project professionalism and maintain composure in handling difficult situations and in times of stress. - Exceptional customer service skills. Educational Requirements: - Required: Associate degree or equivalent work experience Experience Requirements: - Required: Experience in work related customer service function - Required: Computer data entry experience - Required: Intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel) - Preferred: 2 years of experience in related field of expertise or 2 years of administrative experience - Preferred: Experience within the Pharmaceutical/Medical Device Industry #LI-KP1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Title: Virtual Pharmacovigilance Auditor Location: United States Job Description: For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. PV Auditor - 10+ year of experience of PV Auditing - Remote working. Contract opportunity first 4-6 weeks FT hours. Additional as needed hours throughout the remainder of the year. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

Title: Sr. R Programmer (PK/PD) Location: United States Job Description: Full time job requisition id JR 9462 For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Uses R and companion software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Summary of the Essential Functions of the Job - Data preparation and cleaning: - Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis. - Programming PK/PD analyses: - Writing R or Rmarkdown code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships. - Data visualization: - Creating clear and informative graphs and tables to effectively communicate PK/PD findings. - CDISC compliance: - Ensuring data is formatted according to CDISC standards for regulatory submissions - Validation and quality control: - Performing thorough validation checks on programming code and analysis results to maintain data integrity. - Identifies problems and develops tools that increase the efficiency and capacity of the Clinical PK/PD Programming group. Minimum Requirements - Bachelor’s degree in Math, Stats, Computer Science or similar - 3+ years of industrial experience - Must have advanced R programming skills, including tidyverse, ggplot2, Markdown, Quarto, Shiny, etc. Python and/or SAS programming skills are a plus, but not required. - Knowledge of CDISC standards (SEND, SDTM, and ADaM) is required. - Desire to work in clinical PK/PD – knowledge and experience of PK/PD concepts and related programming is highly desirable. - Experience visualizing/presenting data for internal stakeholders or clients - Capable of implementing more advanced modeling and statistical procedures as requested by study team. - Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting/modeling of analysis results. Including handling of data issues and uncleaned data. - Professional attitude, self-motivated, logical thinking - Excellent attention to detail - Strong organization skills and ability to work on multiple tasks simultaneously while achieving quality standards and meeting deadlines - Good verbal and written communication skills. Strong interpersonal skills and ability to work collaboratively across teams - Ability to problem solve and develop innovative approaches along with a drive to learn and master new techniques and technologies We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.