Validus Pharmaceuticals Llc Jobs in Usa
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This role is ideal for candidates who thrive in a fast-paced, team-oriented production environment , focusing on high-volume prescription preparation and automated pharmacy operations .
This position does not involve direct patient interaction, answering phones, or dealing with insurance claims .
The Pharmacy Technician will work under the supervision of a Pharmacist to accurately prepare, package, and distribute medications while ensuring compliance with all federal, state, and HIPAA regulations .
Key Responsibilities Accurately pick, count, and prepare prescription medications including tablets, capsules, and specialty products.
Replenish automated dispensing cells and maintain proper inventory levels.
Utilize handheld scanners to track barcodes, expiration dates, and lot numbers.
Perform quality assurance checks to prevent cross-contamination and ensure product integrity.
Prepare cold chain and specialty prescriptions following strict handling and packaging requirements.
Assist with packing and shipping prescriptions according to established procedures.
Complete weekly cycle counts and audits , assisting with research and discrepancy resolution.
Maintain a continuous and productive workflow to meet daily production goals.
Demonstrate problem-solving skills by identifying, addressing, and escalating operational issues.
Adhere to federal and state pharmacy regulations, safety standards, and HIPAA policies .
Required Qualifications Pharmacy Technician License in the State of Washington National certification through PTCB or ExCPT High school diploma or equivalent Strong attention to detail and accuracy in high-volume, repetitive tasks Ability to work effectively independently and as part of a team Experience in pharmacy operations, medication counting, and inventory management preferred Ideal Candidate Traits Comfortable working in a fast-paced, automated central fill environment Able to maintain focus and consistency in repetitive tasks Strong organizational skills and ability to meet production goals Proactive problem-solver with attention to quality and safety standards Collaborative team player committed to operational excellence and patient safety Why This Opportunity Stands Out Competitive pay: $26.00 per hour Work in a high-volume central fill pharmacy supporting a leading healthcare organization Structured schedule: Sunday through Thursday, with clear shift times Opportunities for career growth and advancement in the pharmacy supply chain industry Join a team-focused, safety-conscious, and quality-driven workplace Qualified candidates with pharmacy technician licensure, national certification, and experience in high-volume automated pharmacy operations are encouraged to apply for this onsite Central Fill Pharmacy Technician opportunity in Everett, Washington .
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At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.
We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a SKAN Isolator; Pharmaceutical Operator (II) to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia. (Relocation + Sign On Bonus )
Overview of this Position:
The SKAN Isolator Pharmaceutical Operator (II) plays a critical role in sterile pharmaceutical manufacturing by operating and maintaining isolator systems for aseptic filling processes. This position ensures compliance with Good Manufacturing Practices (GMP) and supports the production of high-quality injectable drug products in a controlled environment.
Non-Negotiable Requirements:
• At least two (2) years of experience operating isolators in a sterile/aseptic manufacturing facility
• At least two (2) years of experience in a GMP manufacturing facility
• At least one (1) year of experience with routine cleaning, decontamination, and setup of isolators according to SOPs.
•High School Diploma or GED
Preferred Requirements:
• Experience working with Master Control, and/or SAP.
• Experience with cleanroom operations and environmental monitoring
•Experience with automated filling equipment and troubleshooting isolator
•Previous experience in pharmaceutical or biotech manufacturing
•Exceptional attention to detail and communication skills
•Bachelor’s degree in biology and /or Life Sciences
Responsibilities Include:
•Operate isolator systems for aseptic filling of sterile injectable products
•Perform routine cleaning, decontamination, and setup of isolators according to SOPs
•Handle sterile components and materials in compliance with aseptic techniques
•Complete batch records and controlled documentation accurately and timely
•Monitor and document environmental conditions and equipment performance
•Collaborate with Quality Assurance and Engineering teams to resolve issues and maintain compliance
•Participating in training and continuous improvement initiatives
•Maintain a clean and organized work environment in accordance with GMP standards
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.
Safety Monitor II
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.
Responsibilities
- Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
- Reviews safety events.
- Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
- Provides first line evaluation of serious adverse events (SAEs).
- Communicates with site staff regarding reported AEs or SAEs to gather additional information.
- Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
- Coordinates the timely completion and submission of required reports to health authorities and business partners.
- Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
- Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
- Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
- Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
- Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
- Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
- Coordinates with project staff.
- Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
- Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
- Ensures maintenance of documentation required by both corporate and project SOPs.
- Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
- Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
- Guarantees compliance and adherence to the quality standards.
- Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
- Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
- Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
- Completes all relevant professional training in the given scope and time frame.
- Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.
Qualifications
- Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
- 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
- Experience in safety monitoring/pharmacovigilance preferred
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
COMMERCIAL DEVELOPMENT MANAGER
COMPANY OVERVIEW
AlpHa Measurement Solutions is a liquid sensor technology platform serving the complex testing needs of water quality, pharmaceutical, laboratory, and industrial markets with an unmatched combination of precision, reliability, innovation, and flexibility. We are a vertically integrated manufacturer, creating thousands of units and processing several hundred orders and shipments each day for customers throughout the world. We approach the market as both an OEM manufacturer and with our own brands: Van London, ANDalyze, and Aurora Scientific Instruments.
WHAT MAKES ALPHA MEASUREMENT SOLUTIONS SPECIAL
At AlpHa Measurement Solutions, we make analytical sensors and instruments that are essential to everyday life. What we do matters; our products are used to test and monitor water quality in industrial, health, and safety applications worldwide. Our sensors are critical for wastewater and drinking water processing, environmental monitoring, pharmaceutical (vaccine) manufacturing, food & beverage supply, power generation, and many other fundamental applications.
Municipalities, multinational organizations, and system integrators rely upon our sensors as critical, consumable components of their systems around the globe. We at AlpHa understand the important role we play in ensuring safe drinking water, clean aqueous environments, and the general health and safety of communities worldwide.
BENEFITS & PERKS
- Medical, Dental & Vision Insurance
- Health Savings Accounts (HSAs)
- Short-Term Disability
- 401k
- Life insurance
- Paid Vacation
- 8 Paid Holidays per year
- Paid Jury Duty Leave
- Recognition and Reward Programs
- Diverse & Inclusive Work Culture
OPPORTUNITY
AlpHa Measurement Solutions has tremendous opportunity to capitalize on new commercial opportunities and recognizes the need to strengthen its Sales & Marketing capabilities to meet increased demand and support continued growth by further penetrating attractive end markets with its differentiated product portfolio. We have an immediate need for a Commercial Development Manager to lead our Houston-based business development team.
Our company has over 100 years of liquid sensing experience and is accelerating growth through its recent acquisition by Enpro Inc. (NYSE: NPO). Enpro is a leading industrial technology company manufacturing high-performance proprietary products for the semiconductor, aerospace, and compositional analysis sectors. Enpro companies employ nearly 4,000 associates globally, while AlpHa's team consists of over 350 employees, including 235 team members in Houston, Texas and 120 in Shanghai, China. We need an organized and energetic Commercial Development Manager who wants to lead a growing team, who is self-motivated to advance the company's goals, and who can take the Sales Team to the next level.
Our global headquarters is conveniently located in Houston at the southwest intersection of I-69 and Sam Houston Tollway, just north of Sugar Land.
This individual will report to the VP of Sales & Marketing.
Classification : Salaried/Exempt, Full-Time, Monday through Friday, 8:00 AM to 5:00 PM, and as required to maintain business momentum.
JOB DESCRIPTION
Position Summary
The Commercial Development Manager (CDM) is responsible for leading new business development execution and commercialization of New Product Introduction (NPI) initiatives within the commercial organization. This role is structured as a hands-on player–coach, directly managing a team of Business Development Representatives and Inside Sales while personally owning select strategic accounts and growth initiatives.
The CDM drives new account acquisitions, target market expansion, and early-stage product commercialization efforts. Reporting to the VP of Sales & Marketing, this role establishes segment-level priorities, ensures disciplined pipeline development, and maintains accountability for both individual and team performance. The CDM partners cross-functionally with Engineering, Marketing, and Operations to align new product launches and market development strategies with commercial execution.
Essential Functions
Reasonable accommodation may be provided to enable individuals with disabilities to perform the following essential functions:
- Lead and develop the business development team, including hiring, onboarding, coaching, performance management, and development of business development and inside sales resources, while establishing clear prospecting standards, pipeline expectations, and measurable activity metrics aligned with company growth objectives
- Lead business development execution from strategy through implementation, maintaining direct involvement in prospecting initiatives, new account acquisition, forecasts, and customer engagements, while driving accountability through regular pipeline reviews and one-on-one meetings
- Act as a hands-on "player coach", personally leading and supporting new account acquisition efforts across emerging markets and new product launches, including strategic prospecting, trade show engagement, networking, and targeted outreach campaigns
- Directly manage and grow a limited portfolio of strategic or high-impact accounts and opportunities, serving as primary commercial lead in customer meetings, negotiations, pricing discussions, and deal execution
- Support new product launches and capitalize on AlpHa's New Product Development team's efforts by effectively penetrating target end markets with AlpHa's differentiated new sensor technologies
- Own and execute the commercial components of the NPI process from market validation through launch, translating competitive analysis, customer requirements, market feedback, and early adopter engagement into actionable product and go-to-market strategies in alignment with Engineering, Marketing, Commercial, and Operations
- Own the business development and NPI forecasting and budgeting processes, including setting annual targets in partnership with Finance, managing group expenses relative to budget, and measuring performance against revenue and margin objectives
- Establish and approve pricing strategies and deal structures for NPI initiatives and strategic opportunities, ensuring alignment with margin objectives, competitive positioning, and customer value propositions
- Design, implement, and continuously improve business development processes, including prospecting strategies, NPI commercialization workflows, opportunity qualification standards, CRM discipline, and pipeline management to ensure consistency and accountability across the team
- Own and execute the regional trade show strategy in partnership with the North America Commercial team, including show selection, budgeting, messaging, staffing, pre-show planning, on-site execution, and post-show follow
- Use data and analytics to drive decisions, leveraging dashboards, and reporting tools (e.g. CRM, Power BI, etc.) to evaluate NPI launch performance, prospecting effectiveness, pipeline health, conversion rates, and team productivity and conduct regular data-driven business reviews with the executive and cross-functional stakeholders
- Collaborate cross-functionally with Engineering, Marketing, Finance, and Operations to ensure successful product launches, seamless new account onboarding, demand planning alignment, and execution of growth initiatives
- Travel as required to coach team members in the field, engage key prospects / customers, represent the company at trade shows and industry events, and gather market and competitive insights to support strategic growth initiatives
Required Key Competencies
- Drive for Results
- Managing and Measuring Work
- Directing Others
- Strategic Agility
- Customer Focus
- Business Acumen
- Dealing with Ambiguity
- Process Management
Required Qualifications and Experience
- Bachelor's Degree required, preferably in a technical field
- Minimum 5 – 10 years of business development leadership experience in a technical / manufacturing environment, with a strong preference for direct experience in water treatment, liquid analytical sensing / industrial process control, or test & measurement industries
- Must have extensive experience leading business development teams, including managing groups remotely or over a large territory
- Must have proven experience driving commercialization of new products, leading NPI processes, and successfully penetrating new or emerging markets in a technical B2B environment
- Must be comfortable working with and driving diverse team members
- Experienced leader with proven results in making authoritative business decisions, executing decisions and accounting for results
- Excellent communication skills (written and verbal) are required
- Experience with communicating technical and complex information concisely and clearly to senior management
- Successful experience utilizing a CRM and an ERP system to manage team sales tasks, pipeline, closing data, and transaction execution
- Must be analytical and data driven with an ability to analyze multiple leading indicators of revenue and pipeline information to direct team
- Must be highly competent in Microsoft Office, with advanced Excel skills and hands-on experience building, analyzing, and interpreting reports and dashboards in Power BI
- Ability to travel up to 50% of the time
*Enpro Inc. is an equal opportunity employer. Legal authorization to work in the United States is required. We will not sponsor employment visas now or in the future for this job.
*This position involves access to information that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant's capacity to serve in compliance with U.S. export controls.
About the Company
Job Title: IT Infrastructure Support Specialist – IT Services (Pharmaceutical Manufacturing) Location: Lebanon, Indiana, US ---(Onsite)
Required Experience & Qualifications:
- Solid understanding of enterprise networking concepts including LAN/WAN, TCP/IP, VLANs, routing protocols (BGP, OSPF), network security principles, and SD-WAN technologies
- Deep understanding of enterprise-grade network equipment and how they are deployed and supported, including Cisco/Juniper routers, switches, firewalls, and wireless infrastructure
- Strong Network monitoring and troubleshooting experience using tools such as SolarWinds, PRTG, or Wireshark
- Proficiency in deploying and troubleshooting Windows OS (Windows 10/11, Server 2019/2022), end-user devices, and enterprise imaging tools such as SCCM or Intune
- Experience automating repetitive processes using tools or scripting (PowerShell, batch script, python, etc)
- Experience installing and supporting networked printers, scanners, MFDs, and manufacturing floor devices such as barcode scanners and label printers
- Familiarity with Active Directory, Group Policy, virtualization platforms (VMware/Hyper-V), and ITIL-based ticketing systems such as ServiceNow
- Experience providing technical support in a GxP or FDA-regulated pharmaceutical manufacturing environment
- Working knowledge of computer system validation (CSV), change control processes, and GxP documentation requirements
- Ability to work independently while leveraging existing processes and developing new ones to support a site start-up environment
- Strong interpersonal and communication skills with the ability to build effective relationships with cross-functional business partners
- Bachelor's Degree in Computer Science, Information Technology, or a related technical field; certifications such as CCNA, CompTIA Network+, or CompTIA A+ preferred
Senior Manager, Operations
Location: Rochester, NY (Onsite)
Industry: Regulated manufacturing (medical device / life sciences)
Travel: Limited, as needed
Reports to: Director of Manufacturing / Site Operations Leader
Compensation: 170K salary range + 20% bonus + benefits (commensurate with experience)
The Opportunity
A well-established manufacturer operating in a highly regulated environment is seeking a Senior Manager, Operations for the Rochester, NY facility.
This is a high-visibility, senior leadership role with responsibility for a 24x7 multi-shift operation, focused on operational excellence, safety and environmental improvements, equipment performance optimization, and team development. The role plays a critical part in driving performance, reducing operational risk, and strengthening manufacturing systems and culture.
The ideal candidate is a hands-on operations leader and change agent with experience in high-volume manufacturing, strong people leadership capabilities, and a proven ability to improve OEE, quality, and engagement in regulated environments.
Why This Role Is Unique
- Ownership of a mission-critical, 24x7 manufacturing operation.
- Opportunity to strengthen and evolve tiered operating mechanisms and standard work.
- Strong mandate to improve EHS, equipment effectiveness, and process capability.
- High degree of influence across Manufacturing, Quality, R&D, Supply Chain, Finance, and Facilities.
- Blend of strategic leadership and hands-on operational execution.
Key Responsibilities
Operational Leadership
- Lead daily operations to meet production, quality, cost, and safety objectives.
- Set operational goals, KPIs, and development paths for supervisors.
- Deploy, monitor, and sustain standard work across the operation.
- Lead a multi-shift supervisor team supporting a 24x7 manufacturing schedule
Process & Performance Optimization
- Drive continuous improvement initiatives to improve OEE, reduce downtime and waste, and optimize changeovers.
- Assess and improve operational practices to reduce errors and improve process capability.
- Apply formal problem-solving tools while addressing real-world equipment and process challenges.
- Make risk-based decisions to optimize equipment performance while maintaining product quality and employee safety.
Quality & Regulatory Compliance
- Proactively improve quality performance, reduce nonconformances, and drive CAPA implementation.
- Ensure compliance with cGMP, FDA, OSHA, ISO, and internal quality systems.
- Oversee manufacturing documentation, investigations, SOPs, batch records, and NCMRs.
Cross-Functional Collaboration
- Partner with R&D, Quality, Engineering, and Supply Chain on new product introductions, validations, and troubleshooting.
- Communicate capacity constraints, technical risks, and performance trends to Planning and Finance.
- Collaborate with Facilities on short- and long-term equipment and layout planning.
People & Culture
- Lead, mentor, and develop supervisors and operators.
- Foster a culture of accountability, safety, continuous improvement, and performance.
- Support individual development plans and career progression for salaried and hourly employees.
Must-Have Qualifications
- Bachelor’s degree in a scientific or engineering discipline (preferred).
- 8+ years of manufacturing operations experience.
- 3+ years in a leadership or people management role.
- Experience leading high-volume, equipment-intensive manufacturing operations.
- Strong knowledge of GMP and regulated manufacturing environments.
- Experience with manufacturing documentation, investigations, and quality systems.
- Proven ability to drive operational improvements tied to OEE, scrap, waste, and productivity.
- Experience with Lean Manufacturing, Six Sigma, or similar methodologies.
Nice-to-Have / Preferred
- Experience in medical device, pharmaceutical, or similarly regulated industries.
- Lean Six Sigma certification (Green Belt or higher).
- Experience strengthening tiered accountability systems and standard work.
Precision Talent Partners, LLC values diversity and is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive workplace where all employees feel respected, supported, and empowered to contribute. This description reflects management’s assignment of essential functions and does not restrict the tasks that may be assigned. Employment is at-will, and this job description does not constitute a contract of employment.
Global Project Manager - Ophthalmology
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Global Project Manager (GPM) is critical to the successful conduct of Biopharmaceutical -sponsored clinical trials as a matrix leader of the core project team. The GPM is responsible for the successful delivery of a Biopharmaceutical project(s). The GPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The GPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through relationship management.
Responsibilities
- May serve as a primary lead for project bids and multi trial initiatives.
- Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance.
- Develops effective working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
- Serves as the primary point of contact for biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs.
- Tracks project deliverables against contract using Emmes' tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client.
- Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
- Manages project resources (i.e., budget, personnel, and subcontracts).
- Identifies and manages change to scope and requests for out-of-scope activities. Collaborates with Business Development, the Contracts Team, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations.
- May present in bid defense meetings in collaboration with Business Development.
- Develops study management plans in collaboration with core project team members.
- Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
- Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
- Performs other duties as assigned.
Qualifications
- Bachelor's degree in a scientific discipline.
- Minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio including multi-phase research experience in a broad range of indications and client types.
- At least 3 years working in a pharmaceutical and/or CRO setting, serving in a global Trial Team Lead or Global Project Management role or equivalent position.
- Minimum of 2 years of experience in Ophthalmology clinical trials, 5 years of experience preferred.
- Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-4, in a global capacity.
- Demonstrated experience in developing and fostering client and internal relationships.
- Thorough understanding of ICH GCP and applicable global regulatory regulations and
guidelines. - Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions.
- Successful record in managing diverse staff and leading strong teams.
- Strong verbal and written communication skills.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
Senior Analyst, Sales Operations, Basking Ridge, NJ
Who We Are
Aucta Pharmaceuticals is an emerging product development pharmaceutical company.We are on our way to becoming a significant specialty pharmaceutical company in the U.S. marketplace integrating R&D, manufacturing, and commercialization. We focus on improved dosage forms for patients with a therapeutic focus in CNS and select orphan drug disease states.
Aucta successfully launched its first branded product, Motpoly XR, in the epilepsy space with a targeted sales force in March 2024 and an expanded presence of 20 field sale territories and 3 inside sales positions in late 2024. Our objective is to enhance our marketing, managed care, and sales capabilities to support future pipeline products in neurology over the coming years.
Position Description
The Senior Analyst, Sales Operations, is a key member of Aucta’s Commercial Operations team and plays a critical role in enabling sales effectiveness, operational execution, and data-driven decision-making across the organization.
This role serves as the primary point of contact and vendor manager for core Sales Operations platforms, including Veeva CRM, MMIT, and Power BI, and is responsible for managing core quarterly commercial processes such as Incentive Compensation updates, targeting changes, sales force size and structure adjustments, and system governance.
In addition, this position leads the development and maintenance of training materials and delivers training for both field and inside sales and home office teams across Commercial Operations tools and platforms.
This is a highly visible, hands-on role in a fast-growing environment that requires strong analytical skills, operational rigor, comfort working cross-functionally, and the ability to translate complex data and systems into clear, actionable guidance for the business.
The role reports to the Director of Sales Operations.
Primary Responsibilities:
Sales Operations & Vendor Management
- Serve as the primary point of contact and internal owner for Sales Operations tools and vendors, including Veeva CRM, MMIT, Power BI, and related commercial analytics platforms.
- Manage vendor relationships, system enhancements, issue resolution, upgrades, and roadmap discussions to ensure tools meet evolving business needs.
- Partner with IT, Finance, Sales leadership, and external vendors to maintain data integrity, system performance, and compliance.
Commercial Process Management
- Own and manage the quarterly change process for:
- Incentive compensation plan updates and calculations
- Targeting and call plan changes
- Sales force size, structure, and territory adjustments
- Ensure timely, accurate execution of all changes and clear communication with stakeholders.
- Support forecasting, goal setting, and sales performance tracking activities.
Analytics & Reporting
- Utilize advanced Excel, SQL, and Power BI to analyze sales performance, trends, and operational KPIs.
- Build, maintain, and enhance dashboards and reports to support Sales leadership, Commercial Operations, and Executive leadership.
- Partner cross-functionally to translate business questions into data-driven insights.
Training & Enablement
- Develop, maintain, and continuously improve training materials (guides, SOPs, slide decks, job aids) for Sales Operations tools and processes.
- Conduct training sessions for field and inside Sales and home office associates on:
- Veeva CRM functionality and best practices
- MMIT data usage and interpretation
- Power BI dashboards and reporting
- Other Commercial Operations platforms as needed
- Serve as a trusted resource for ongoing user support and best-practice guidance.
Cross-Functional Support
- Collaborate closely with Sales, Marketing, Managed Care, Finance, and leadership to support commercial execution.
- Participate in sales meetings, planning sessions, and plan-of-action meetings as needed.
- Identify opportunities for process improvement, automation, and scalability as the organization grows.
Required Qualifications
- Bachelor’s degree in Business Administration, Finance, Analytics, Information Systems, or a related field.
- 3-5+ years of experience in Sales Operations, Commercial Operations, or analytics roles, preferably within the pharmaceutical or healthcare industry.
- Hands-on experience with Veeva CRM, MMIT, and Power BI strongly preferred.
- Advanced proficiency in Microsoft Excel (including complex formulas and data modeling); SQL experience preferred.
- Strong understanding of sales force structure, targeting, incentive compensation, and CRM processes.
- Demonstrated ability to manage vendors and cross-functional stakeholders.
- Strong communication and training skills, with the ability to explain technical concepts to non-technical audiences.
- Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
- Proactive, collaborative team player with a strong sense of ownership and accountability.
Work Location:
This position is based at our Basking Ridge, NJ site. It is an office-based role, requiring presence 5 days a week. The selected candidate must be able to commute to Basking Ridge, NJ
Salary Range
Aucta Pharmaceuticals considers a combination of education, experience, internal equity, and external market data when determining compensation.
- Base Salary: $80,000 – $110,000 (commensurate with experience)
- Bonus Incentive: 10%
Benefits
Aucta offers a competitive benefits package, including:
- Medical, Dental, and Vision Insurance
- 401(k)
- Life Insurance
- Short- and Long-Term Disability
- Paid Time Off (PTO)
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Applications will be accepted until the position is filled.
Prinston Pharmaceutical Inc.
About Us:
Prinston Pharmaceutical, Inc. is a fully integrated pharmaceutical company engaged in product development, product registration, manufacturing, marketing, and sales of high-quality affordable generic prescription products to customers. We deliver and maintain high quality and integrity in all our products manufactured in world-class cGMP manufacturing facilities. Our highly experienced R&D team meets market needs through innovation rapidly, bringing cost-effective quality products to the US market and help patients get the best pharmaceutical products simultaneously reducing their medical cost. We currently have an immediate opening for a corporate paralegal at Prinston Pharmaceuticals Inc., located in Somerset, New Jersey. This is an excellent opportunity to work on meaningful projects and exposure to a corporate environment in global/international setting.
Job Title: Paralegal
Corporate Paralegal/Legal Assistant will work on a range of projects that will support the legal team.
Roles and Responsibilities:
Assist with reviewing, drafting and revising various contracts to support sales and marketing teams including CDAs, MSAs, SOWs, supply agreements, collaboration agreements, etc.
- Prepare correspondence, reports, presentations, and other materials.
- Perform legal research.
- Review and monitor laws and regulations in relevant fields.
- Maintain procedures, forms, and legal policy documents.
- Assist with litigation and dispute resolution.
- Manage Intellectual property portfolios.
- Coordinate matters with Human Resources, as necessary.
- Other duties may be assigned.
Qualifications:
- B.A with prior legal assistant/paralegal experience or currently enrolled in a J.D. program at an accredit academic institution, preferably second or third-year law student.
- Extensive knowledge of corporate governance, intellectual property, employment litigation and Human Resources related law is required.
- A corporate paralegal with prior experience at a pharmaceutical manufacturer.
- Strong organizational, customer service, and project management skills.
- Strong work ethic, positive attitude, and professional demeanor.
- Ability to work independently and as part of a team.
- Excellent verbal and written communication skills.
- Must be eligible to work in the U.S. and able to start work immediately
Benefits:
- 401(k)
- Health insurance
- Dental insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Job Type: Full-time
Salary: $70,000 - $90,000
Location: Somerset, NJ (on-site)
Position Overview The Medicare Representative II works closely with healthcare providers to process prior authorizations (PA) and drug benefit exception requests in accordance with Medicare Part D CMS regulations on behalf of the client.
This role requires reviewing requests, gathering additional information from providers, and ensuring all coverage determinations are processed accurately and in compliance with regulatory guidelines.
Representatives must apply plan criteria using internal systems and documented work instructions while maintaining high-quality customer service.
Key Responsibilities Process prior authorization (PA) and drug benefit exception requests for Medicare Part D members.
Review and apply plan criteria using internal systems and work instructions.
Conduct research and contact healthcare providers via phone to obtain necessary clinical or administrative information.
Accurately document and complete all required steps to resolve and close cases .
Identify and correct issues within the processing workflow.
Provide phone assistance to initiate or resolve coverage requests.
Escalate complex cases to Coverage Determinations and Appeals clinical pharmacists and management when necessary.
Ensure strict compliance with CMS regulations, department standards, and internal policies .
Maintain high levels of accuracy, productivity, and quality assurance standards .
Required Skills & Competencies Healthcare & Call Center Experience Demonstrated ability to manage high workloads in healthcare call centers or healthcare-related environments.
Familiarity with insurance plans including Commercial, Medicare, and Medicaid.
Understanding of pharmacy benefit management (PBM) processes is preferred.
Technical Proficiency Strong computer skills with the ability to navigate multiple software systems simultaneously.
Comfortable working within various internal databases and case management tools.
Communication Skills Excellent verbal and written communication skills.
Strong active listening and problem-solving abilities.
Professional, empathetic communication style when interacting with healthcare providers and patients.
Analytical & Problem-Solving Skills Ability to analyze case details and determine appropriate next steps.
Strong attention to detail and accurate data entry skills to maintain compliance and avoid processing errors.
Work-From-Home Readiness Comfortable working independently in a remote environment.
Experience using collaboration tools such as: Microsoft Teams Video conferencing platforms Email and messaging tools Must be webcam-ready when required.
Technical Requirements (Remote Work) Employees must maintain a dedicated home workspace with: Wired Ethernet connection required (Wi-Fi not permitted) Reliable internet service with minimum speeds: 25 Mbps download 5 Mbps upload Compliance & Professional Expectations Strict adherence to HIPAA regulations and patient privacy standards.
Maintain compliance with CMS guidelines and internal procedures.
Follow company attendance policies and remain fully engaged throughout scheduled shifts without personal distractions.
Minimum Qualifications 2+ years of healthcare or healthcare call center experience, including: Problem resolution Business writing Customer service Quality improvement processes 6 months of remote/virtual work experience where the supervisor is not physically present 6 months of high-volume call center experience (required) 6 months of PBM or pharmaceutical-related experience (strongly preferred)