Validus Pharmaceuticals Llc Jobs in Usa

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 Pharmaceutical Operator (II) to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia. (Relocation Available)

Overview of this Position:

The 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.

The Pharmaceutical Sales Representative Diabetes/Endocrinology is responsible for the achievement of commercial objectives in the assigned territory in alignment with Xeris' corporate goals. Reporting to the Regional Business Director (RBD), the PSR will participate in the development and execution of strategic and tactical territory and account level business plans in order to meet and exceed sales goals and business objectives.

• Deliver on corporate objectives specific to territory.
• With RBD and internal business partner input, develop, evolve, and execute territory and account level business plans.
• Engage RBD with timely recommendations to eliminate or minimize barriers to progress specific to marketplace trends, business opportunities and threats, competitive information, etc.
• Leverage internal expertise to maximize field impact.
• Work with Regional Business Directors, Channel/Trade & Market Access Teams, and Sales Representatives to develop territory-specific strategies to ensure patient access to Xeris products.
• Manage territory budget and resource allocations to maximize return on investment.
• Create a face to the internal and external customer that demonstrates Xeris' commitment to bringing value and solutions to the customers and patients we serve.
• Collaborate with peers, marketing, and training personnel to share information and implement territory initiatives/strategies.
• Create, build, and maintain relationships and regular communications and sales efforts with physicians & other health care providers, and all others pertinent to Xeris' business.
• Professionally and ethically represent Xeris to external customers (including but not limited to hospitals, IDNs, individual physicians and health care providers, and local diabetes chapters) and foster their respect by demonstrating our commitment to advancing patient care and outcomes.
• Professionally and ethically represent Xeris internally and foster professionalism within, among, and beyond the region.
• Take responsibility for ongoing professional development to maximize effectiveness in advancing Xeris' objectives.
• Leverage internal training and development.
• Refine ability to navigate complex and multi-layered accounts
• Refine ability to effectively communicate and engage with customers while leveraging Xeris internal resources.

• Bachelor's Degree in Health Sciences, Business/Marketing, or related field.
• Sales position level is determined by candidate experience and capabilities. At Xeris Pharmaceuticals, levels of consideration are based on the following:
  • 2+ years of experience in field commercial positions, including but not limited to: sales representative, hospital representative, sales trainer, and marketing
  • 5+ years of experience in bioscience commercial positions, including but not limited to: sales representative, hospital representative, sales training, marketing and regional account manager
• Recent experience in bioscience and/or diabetes is highly desirable
• Able to create and execute a thoughtful business plan adjusting when needed in order to meet organizational goals.
• Proficient in understanding key data and metrics and utilizing this information to improve business performance.
• Thrives in ambiguity and uncertainty; can adapt quickly in any situation and asks questions to increase depth of understanding.
• Competencies: Self-directed, Organizational skills, Verbal and Written Communication skills, Time Management, Presentation skills, Project Management skills, Problem Solving, Negotiation skills, Influencer, Adaptability
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel requirements will vary by territory but will minimally be 20%.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $85,000 to $130,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Join a leading pharmaceutical company’s Data Science team, where you’ll drive and lead advanced analytics across Marketing, Sales, and Access. As Associate Director (Or Sr Manager), A HIGH LEVEL INDIVIDUAL CONTRIBUTOR, you’ll lead strategic initiatives from predictive modeling and personalization to field force optimization, delivering scalable solutions that inform commercial decisions and enhance patient engagement. Deep experience in pharmaceutical marketing analytics is essential to translate brand strategy into actionable insights.

Keywords: MMM, Next Best Action, NLP, Data Science, HCP, GenAI

Location: Onsite 3 days a week in Cambridge, MA

Key Responsibilities

• Lead development and deployment of predictive models, segmentation, NLP, and GenAI tools to solve complex commercial challenges
• Translate pharmaceutical brand objectives into analytics frameworks across marketing, sales, and access
• Design and operationalize Next Best Action strategies to boost omnichannel engagement and HCP ROI
• Build and scale Patient 360 models and targeting algorithms for AI-driven lead generation
• Guide stakeholders through insight activation and integration into workflows
• Champion model governance, experimentation, and analytical rigor
• Collaborate with IT to develop ML Ops environments and productized solutions
• Manage external analytics partners and ensure alignment across data engineering, insights, and compliance

Who You Are

A strategic data scientist with strong business acumen, leadership presence, and deep experience in pharmaceutical marketing analytics. You thrive at the intersection of data and action, delivering measurable impact.

Qualifications

• 5+ years in analytics role within pharmaceutical industry
• Proven experience in pharmaceutical marketing analytics, including brand strategy, HCP engagement, and omnichannel optimization
• Expertise in NBA, MMM, supervised/unsupervised learning, A/B testing, time-series forecasting
• Success in marketing mix modeling, decision engines, and GenAI product design
• Proficient in Python, R, SQL, Snowflake; skilled in Power BI or Tableau
• Familiarity with APLD, PlanTrak, claims, and specialty pharmacy datasets
• Strong communicator with executive presence and cross-functional influence

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A well-established, FDA-regulated pharmaceutical manufacturing organization is seeking a Director of Quality to lead all Quality Assurance and Quality Control operations at its U.S. production site. This is a high-impact leadership opportunity to own and govern the full cGMP Quality Management System across both liquid and solid dose manufacturing in a commercial environment.

This role is ideal for a seasoned pharmaceutical quality leader who wants true authority, autonomy, and executive partnership within a stable, vertically integrated manufacturing organization.

The Opportunity

You will serve as the final authority for batch record review and product release, overseeing the integrity of the entire quality system in compliance with 21 CFR 210/211. Reporting directly to executive leadership, you will ensure inspection readiness, sustained compliance, and operational excellence across QA and QC.

This is a hands-on leadership role where your decisions directly protect product quality, patient safety, and regulatory standing.

What You Will Own

• Design, implement, and maintain a fully compliant cGMP Quality Management System
• Final decision authority on batch record review and commercial product release
• Oversight of deviations, investigations, CAPAs, change control, and complaint handling
• Regulatory inspection leadership (PAI, routine, and for-cause)
• Governance of third-party contractors and laboratories
• Establishment and audit of procedures, specifications, and manufacturing controls
• Executive-level risk reporting and quality performance metrics

You will lead a team of approximately 25–30 quality professionals (QA and QC), including multiple managers and laboratory staff.

What We’re Looking For

• 10+ years of pharmaceutical manufacturing quality leadership experience
• Direct experience in commercial pharmaceutical production (not medical device or food)
• Deep expertise in 21 CFR 210/211 and FDA regulatory expectations
• Proven authority over final batch release decisions
• Experience leading FDA inspections and responding to regulatory observations
• Demonstrated oversight of deviations, CAPAs, investigations, and complaint systems
• Strong cross-functional leadership skills and executive communication ability
• Bachelor’s degree in Chemistry, Biology, or related discipline

This role requires someone who can operate independently, maintain regulatory integrity, and collaborate effectively with operations and scientific leadership.

About the Organization

• FDA-regulated manufacturing site operating since 1946
• Vertically integrated producer of liquid and solid dose medications
• One of the largest producers of liquid antacid products in the U.S.
• Approximately 100 employees
• 132,000-square-foot manufacturing facility
• Long-term ownership and stable operational history

The plant is located in Gulfport, Mississippi, approximately:

• 5 miles from the beach
• 1 hour from Mobile
• 1.5 hours from New Orleans
• Low cost of living with strong military and industrial presence in the region

Compensation & Benefits

• Base salary $120,000 – $150,000+ (flexible for the right candidate)
• Relocation support available
• PTO plus additional paid holidays
• Approximately 22 additional annual paid holiday closures
• Medical, Dental, Vision, Disability, and supplemental plans available

Interview Process

• Brief HR screen
• Executive virtual interview
• Onsite interview
• Offer

**This RSM role covers the state of Washington, San Fran, San Jose, Fresno, Las Vegas and the surrounding areas**

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help

patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Regional Sales Manager

The Regional Sales Manager (RSM) will be responsible for leading and providing strategic direction for Commercial Sales, including sales strategies, productivity, sales training and effectiveness, and ensuring achievement of performance targets and budgeted sales goals. As the leader of the Company’s field sales force, you are responsible for direct management, development, and supervision of assigned Territory Managers and their implementation of processes within local geography in accordance with approved sales and marketing resources and ensuring all sales personnel operate in an effective, efficient and compliant manner. This role reports into the National Sales Director. The RSM must live within the assigned region.

Essential Duties and Responsibilities*

•Develop and implement Regional business plans, budgets and maintain overall responsibility of action plans for the Region.

• Review performance metrics with the National Sales Director to ensure sales team is achieving maximum sales results.
• Plan and conduct meetings with the Sales Team; ensure appropriate leadership by developing and inspiring the Sales Team.
• Work closely with leadership and Market Access to maximize reimbursement from commercial & government payers.
• Create and manage Regional plans including message, reach and frequency, and budget goals. Responsible for goal- and target-setting.
• Evaluate account management performance against budget to ensure a cost-effective allocation of resources and appropriate management reporting.
• Be in the field three (3) to four (4) days working with assigned Territory Managers and complete Field Coaching Reports (FCR) with quality and in a timely manner (48-72 hours). Hold office hours on days out of the field.
• Complete all training and policy requirements on time.
• Ensure that all actions and those of his/her team both internally and through vendors
• working on our behalf, are in compliance with all laws, regulations and policies and demonstrate Company values.

*Additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree preferred. Experience in sales management in the pharmaceutical industry may be substituted.
• 8+ years of Pharmaceutical Sales experience preferred; or equivalent medical sales experience may be substituted.
• 3+ years sales management experience in a U.S. pharmaceutical or biopharmaceutical organization preferred.
• 2+ years’ experience in Cardiology (Statin, PCSK9, and NOAC) launch experience preferred.
• Proven track record of success in launching new products and/or indications and building sales teams.
• Well-developed leadership skills, and the ability to influence people at all levels inside and outside the organization.
• Demonstrated track record of successfully commercializing new products and/or expanding commercial opportunities for existing products. Sets compelling goals and is tenacious in accomplishing them. Ability to set priorities, allocate resources, take accountability, and achieve results.
• Proven ability to forge strong, diverse teams of people with multiple perspectives and talents. Have successfully created an environment in which cross-functional teams are highly motivated to accomplish goals.
• Demonstrated excellent presentation and communication skills. Proven ability to influence and work successfully with varied audiences, including customers, colleagues, scientific and technical leaders, pharmaceutical and business partners, collaborators, and senior executives.
• Excellent verbal and written English communications skills.
• Travel requirement: Up to 50% - 60% including overnight stays.

**This RSM role covers the state of Washington, San Fran, San Jose, Fresno, Las Vegas and the surrounding areas**

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help

patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Regional Sales Manager

The Regional Sales Manager (RSM) will be responsible for leading and providing strategic direction for Commercial Sales, including sales strategies, productivity, sales training and effectiveness, and ensuring achievement of performance targets and budgeted sales goals. As the leader of the Company’s field sales force, you are responsible for direct management, development, and supervision of assigned Territory Managers and their implementation of processes within local geography in accordance with approved sales and marketing resources and ensuring all sales personnel operate in an effective, efficient and compliant manner. This role reports into the National Sales Director. The RSM must live within the assigned region.

Essential Duties and Responsibilities*

•Develop and implement Regional business plans, budgets and maintain overall responsibility of action plans for the Region.

• Review performance metrics with the National Sales Director to ensure sales team is achieving maximum sales results.
• Plan and conduct meetings with the Sales Team; ensure appropriate leadership by developing and inspiring the Sales Team.
• Work closely with leadership and Market Access to maximize reimbursement from commercial & government payers.
• Create and manage Regional plans including message, reach and frequency, and budget goals. Responsible for goal- and target-setting.
• Evaluate account management performance against budget to ensure a cost-effective allocation of resources and appropriate management reporting.
• Be in the field three (3) to four (4) days working with assigned Territory Managers and complete Field Coaching Reports (FCR) with quality and in a timely manner (48-72 hours). Hold office hours on days out of the field.
• Complete all training and policy requirements on time.
• Ensure that all actions and those of his/her team both internally and through vendors
• working on our behalf, are in compliance with all laws, regulations and policies and demonstrate Company values.

*Additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree preferred. Experience in sales management in the pharmaceutical industry may be substituted.
• 8+ years of Pharmaceutical Sales experience preferred; or equivalent medical sales experience may be substituted.
• 3+ years sales management experience in a U.S. pharmaceutical or biopharmaceutical organization preferred.
• 2+ years’ experience in Cardiology (Statin, PCSK9, and NOAC) launch experience preferred.
• Proven track record of success in launching new products and/or indications and building sales teams.
• Well-developed leadership skills, and the ability to influence people at all levels inside and outside the organization.
• Demonstrated track record of successfully commercializing new products and/or expanding commercial opportunities for existing products. Sets compelling goals and is tenacious in accomplishing them. Ability to set priorities, allocate resources, take accountability, and achieve results.
• Proven ability to forge strong, diverse teams of people with multiple perspectives and talents. Have successfully created an environment in which cross-functional teams are highly motivated to accomplish goals.
• Demonstrated excellent presentation and communication skills. Proven ability to influence and work successfully with varied audiences, including customers, colleagues, scientific and technical leaders, pharmaceutical and business partners, collaborators, and senior executives.
• Excellent verbal and written English communications skills.
• Travel requirement: Up to 50% - 60% including overnight stays.

Packaging Mechanic (2nd Shift)

$32 – $37/hour + 10% shift differential

Pharma Manufacturing | Bethlehem, PA

6-month Contract (Solid potential to be hired on if you possess strong electrical skills)

Are you an experienced Packaging Mechanic with a passion for pharmaceutical manufacturing? We’re seeking a dedicated Packaging Mechanic to ensure our state-of-the-art facility runs smoothly and efficiently. This is an excellent opportunity to grow your career with a fast-growing company dedicated to innovation and quality.

Key Responsibilities:

• Perform preventive maintenance on advanced packaging equipment to minimize downtime and ensure optimal performance.
• Set up, calibrate, and execute changeovers of packaging machinery to meet production schedules.
• Monitor and analyze machinery operation, quickly identifying and resolving issues to maintain continuous production.
• Maintain equipment in compliance with cGMP (current Good Manufacturing Practices) to ensure product quality and regulatory adherence.
• Troubleshoot and repair vision systems, serialization units, barcode readers, and PLC-controlled machinery.
• Collaborate closely with Engineering teams to install, optimize, and upgrade packaging systems.
• Maintain detailed documentation of maintenance activities and equipment qualification status.

Qualifications:

• Previous experience with packaging lines preferred; cGMP experience is a plus.
• Strong mechanical aptitude with excellent troubleshooting skills.
• Proficiency with PLCs, HMIs, pneumatics, and electromechanical systems.
• Knowledge of serialization and barcode systems.
• Demonstrated experience working with servo and PLC-driven machinery.
• Pharmaceutical manufacturing experience (2+ years) is advantageous.
• Forklift operation experience preferred.

Why Join Us?

• Opportunity to work with cutting-edge pharmaceutical technology in a modern facility.
• Competitive pay rate with available overtime to boost earnings.
• Potential for permanent placement based on performance.
• Gain valuable experience in a regulated cGMP environment.
• Supportive team environment with a focus on safety, quality, and continuous improvement.
• Clear pathways for career advancement and skill development within a growing industry.

If you’re detail-oriented, proactive, and eager to contribute to a dynamic manufacturing environment, we want to hear from you! Apply today to join a company committed to excellence and innovation in pharmaceutical packaging.

• Join a fast-growing specialty pharma company focused on neurology and CNS therapies
• Be part of a major expansion following a successful new drug launch
• Comprehensive benefits: health, dental, vision, 401(k), life, disability, PTO
• Collaborate directly with leadership to shape future product launches
  
  

• Manage and grow an assigned neurology/epilepsy sales territory
• Develop and maintain strong relationships with physicians, hospitals, and key accounts
• Promote the company’s flagship epilepsy product using clinical and market insight
• Execute strategic sales plans and exceed quarterly revenue goals
• Collaborate with marketing, managed care, and internal teams to drive territory success
  
  

• Bachelor’s degree with proven success in pharmaceutical or biotech sales
• Launch experience in CNS or neurology preferred
• Strong communicator with exceptional relationship-building and negotiation skills
• Self-motivated, competitive, and results-driven
  
  

Management Sciences for Health (MSH) is a global health nonprofit that makes foundational changes to health systems to protect people from diseases and improve their health. MSH collaborates with local partners, from the Ministry of Health to the community, to strengthen and complement existing health systems. Since 1971, MSH has worked in more than 150 countries to help ensure sustainable, resilient, and equitable access to quality health care around the globe.

MSH invites qualified, individual consultants to express their interest in joining the MSH Consultant Roster for potential future collaborations in the global health sector. We encourage professionals with diverse skills and experiences to express their interest in joining the roster by submitting an application.

Consultants can be remote or on-site as required by MSH.

Fill out the online application form and attach your latest CV and a cover letter. Applicants must indicate their skills by selecting them from the drop-down list. Please note that submission of an application does not guarantee automatic selection for the roster. MSH will contact candidates as needed.

Required Skills: Applicants that wish to apply for the Supply Chain & Pharmaceutical System Strengthening roster should possess the following skills/experiences:

• Supply Chain Management
• Pharmaceutical System Strengthening
• Supply Chain Planning
• Supply Chain Systems
• Logistics Management Information Systems
• Track and Trace
• CO2 Emission Reduction
• Stakeholder Management & Governance
• Performance & Reporting

MSH is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. MSH complies with Section 503 of the Rehabilitation Act, Section 4212 of the Vietnam Era Readjustment Assistance Act, as amended, and all related applicable regulations.

Title: Data Migration Specialist

Location: San Diego, CA

Duration: 6-9 Month Assignment + Potential Extensions

Work Model: Fully On-Site

Pay rate: $21-23/hour

Start Date: March 16, 2026

JOB DESCRIPTION

One of our large CDMO clients is seeking data migration specialist to transition from a legacy Quality Management System (QMS) to MasterControl. This role focuses on extracting structured and unstructured data from the previous QMS platform, validating its accuracy, and entering and organizing information within MasterControl according to established procedures. The ideal candidate is detail‑oriented, highly organized, and comfortable working with quality documentation and regulated data environments.

Key Responsibilities

• Extract data from the legacy QMS, including documents, records, metadata, and historical logs.
• Review, clean, and validate extracted data to ensure accuracy, completeness, and compliance with internal standards.
• Input and upload data into MasterControl following defined workflows and naming conventions.
• Collaborate with Quality, IT, and Compliance teams to resolve discrepancies and clarify data requirements.
• Maintain detailed logs and status reports to track progress and identify issues during migration.
• Support testing and verification activities to ensure data integrity after import into MasterControl.
• Follow all SOPs, work instructions, and regulatory guidelines related to data handling and documentation control.

Required Skills and Experience:

• High School Diploma
• Experience with Data Entry or Document Control in a regulated environment
• Ability to type 40+ words per minute
• Microsoft Office proficiency

Nice to Have Skills & Experience:

• Experience with MasterControl

Compensation:

$21.00/hr to $23.00/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k)-retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.

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.

• 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.

• 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

Job Overview

We are seeking an experienced Senior Logistics Manager to lead and optimize our supply chain operations supporting our pharmaceutical manufacturing and distribution. This position is responsible for ensuring compliance with regulatory requirements, driving efficiency in warehousing, shipping, and receiving operations, and managing both internal teams and external logistics providers. The ideal candidate brings a strong understanding of cGMP, GDP, FDA and ISO standards, along with proven leadership in pharmaceutical logistics. This position offers an opportunity to influence strategic logistics decisions, enhance operational efficiency, and drive continuous improvement within a dynamic environment.

Responsibilities

• Provide leadership and strategic direction for warehousing, inventory control, shipping, and receiving operations.
• Ensure all logistics operations meet regulatory compliance standards including cGMP, GDP, ISO, and FDA requirements.
• Direct and mentor a high-performing logistics team, including supervisors and warehouse personnel, to meet key performance targets.
• Manage ERP and logistics systems (IQMS preferred), including inventory accuracy, production tracking, and reporting.
• Schedule and manage inbound and outbound transportation including internal trucking and contracted freight services.
• Oversee documentation such as advanced shipping notices, pick slips, bills of lading, and inventory reports.
• Develop and implement logistics SOPs to ensure operational consistency, efficiency, and quality assurance.
• Analyze logistics data to identify trends, improve performance, and reduce costs.
• Collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Procurement teams to support supply chain continuity.
• Set and review daily, weekly, and monthly operational goals for the logistics department.
• Lead audits and continuous improvement projects related to inventory control, barcoding, shipping processes, and ERP integration.
• Maintain accurate shift documentation, Excel trackers, and ERP reports for real-time decision-making.
• Monitor KPIs related to order fulfillment, shipping accuracy, cost control, and delivery timelines for continuous improvement.

Skills

• 10+ years of experience in logistics, with at least 5 years in a leadership role within a manufacturing environment.
• Proven experience in cGMP, ISO, and quality system execution.
• Strong ERP experience, preferably IQMS or equivalent.
• Advanced knowledge of inventory control and barcoding systems.
• Experience with EDI and regulatory shipping documentation.
• Extensive experience in supply chain management, logistics operations, and warehouse distribution.
• Proficiency in demand planning, procurement strategies, category management, and sourcing.

Preferred:

• Bachelor’s degree in supply chain, Logistics, Business, or related field.
• Strong knowledge of pharmaceutical distribution and cold chain logistics.

Ability to adapt quickly to changing priorities while maintaining attention to detail in a fast-paced environment. This role is ideal for a strategic thinker with a comprehensive understanding of modern supply chain practices who is eager to lead innovative logistics solutions that support organizational growth and operational excellence.