Professional Aesthetic Consultant - Pasadena
Consultant job at Revance Therapeutics
The Professional Aesthetic Consultant (PAC) promotes the product portfolio to targeted aesthetic customers within a designated geographical area. This role will create product acceptance and enhance portfolio growth through various business development activities. The PAC provides technical product and procedure expertise.
* Reporting to: Regional Sales Director
* Location/Territory: Pasadena & San Gabriel Valley
* Salary Range: *$95,000-$100,000 annually + uncapped commission
* the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.
Responsibilities/Essential Duties:
* Strategically manages the territory to meet or exceed sales objectives.
* Responsible for lead generation through direct contact with customers in assigned area.
* Maintains effective customer relations, develops opportunities for growth within an existing customer base, and assures market penetration and profitability while achieving sales forecasts.
* Delivers sales results per assigned quarterly goals, and have primary responsibility for area metrics, issues and customers.
* Maintains a pipeline of opportunities to meet or exceed sales objectives.
* Provides and filters key market insights back to sales and marketing management.
* Maintains accurate reporting, records and files necessary for proper management of territory.
* Positively represents Revance throughout customer locations.
* Actively participates in sales meetings, conference calls, and other necessary business meetings.
* Demonstrates honesty and integrity while modeling behaviors consistent with company standards, and adheres to all sales policies and procedures.
Basic Qualifications:
* Master's degree or Bachelor's degree
* Minimum 2 years of outside sales experience in the Medical or Aesthetics industry
Preferred Qualifications:
* 5+ years of sales/account management experience a plus
* History of meeting and exceeding sales objectives.
* Experience in medical aesthetics, dermatology, or plastic surgery a plus
* Launch experience.
* Experience in buy and bill or cash pay medicine a plus
* Advanced business acumen; understands competitors, influencers and industry trends.
* Ability to work in a launch or fast-paced, highly visible and dynamic environment.
* Strong knowledge of analytics, budgeting and key revenue drivers; able to leverage data to target and prioritize opportunities.
* A valid driver's license is required
Company Summary:
Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you:
* Competitive Compensation including generous base salary and incentive compensation
* Flexible unlimited PTO, holidays, and parental leave
* Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more
This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Auto-ApplyBusiness Analyst, Enterprise Projects
Temecula, CA jobs
Job Details Temecula - Temecula, CA Flower Mound - Flower Mound, TX; Kernersville - Kernersville, NC Fully Remote $105000.00 - $135000.00 SalaryDescription
The Business Analyst, Enterprise Projects provides structured analysis and documentation to support enterprise-wide initiatives across infrastructure, technology modernization, cybersecurity, compliance readiness, and operational optimization. This includes direct, hands-on involvement in Disaster Recovery (DR) and Business Continuity Planning (BCP), HITRUST audits, cloud maturity documentation, and the implementation of IT governance processes such as Change Management. This role is responsible for capturing, translating, and validating complex business requirements into measurable deliverables, including functional specifications, use cases, and integration plans, ensuring alignment with organizational objectives and technical standards.
The Business Analyst works directly with project managers, IT professionals, business units, and external vendors to clarify requirements, man-age dependencies, and identify risks before escalation. By applying disciplined methodologies and maintaining comprehensive, audit-ready project records, the role enables consistent execution of high-impact initiatives and provides leadership with decision support and performance insights to prioritize resources effectively.
Essential Functions and Duties
Requirements Analysis & Documentation:
Conduct structured interviews, workshops, and workflow mapping sessions with stakeholders to capture current processes, dependencies, and target outcomes.
Translate business requirements into testable functional and technical specifications, including workflows, use cases, and traceability matrices.
Develop business rules and acceptance criteria to ensure solutions are measurable and verifiable.
Validate requirements through iterative stakeholder reviews to eliminate scope ambiguity or misalignment.
Ensure documentation meets compliance and audit-readiness standards and provides full traceability for future enhancements, including HITRUST certification requirements, cybersecurity controls, and regulatory compliance frameworks.
Perform impact analyses to evaluate downstream effects on workflows, data, and integrated systems.
Project Execution Support:
Collaborate with project managers to define scope, timelines, deliverables, and contingency plans for assigned initiatives.
Support both Agile and Waterfall project approaches by maintaining backlogs, sprint artifacts, and change control documentation with precision.
Coordinate with external vendors to ensure alignment on deliverables and resolve requirement gaps prior to implementation.
Participate in formal testing and validation to confirm requirements are met and performance criteria are achieved.
Maintain a central repository of project artifacts, including risk registers, change logs, and dependency maps, supporting DR/BCP testing results, cloud maturity documentation, and governance change control processes.
Provide post-implementation reviews to confirm outcomes meet business case expectations and capture lessons learned.
Stakeholder Collaboration & Communication
Serve as the primary liaison between business stakeholders and technical teams to maintain shared understanding of objectives, constraints, and success metrics.
Facilitate structured alignment workshops and decision checkpoints to resolve trade-offs and clarify dependencies.
Develop communication plans for executives and sponsors, delivering updates with context, data, and actionable recommendations.
Provide accurate reporting of project status, risks, and readiness for key decisions to leadership and governance bodies.
Process Improvement & Governance:
Identify opportunities to streamline workflows and reduce redundancy through automation or integration of systems.
Recommend solutions that align with governance policies, security protocols, and operational risk requirements, including HITRUST, HIPAA, and other compliance frameworks.
Develop standardized operating procedures (SOPs) to institutionalize successful workflows and maintain compliance.
Create metrics dashboards to monitor performance, adoption rates, and solution effectiveness.
Contribute to governance playbooks and cross-departmental training materials to support consistent project delivery.
General Responsibilities:
Adheres specifically to all company policies and procedures, Federal and State regulations, and laws.
Display dedication to position responsibilities and achieve assigned goals and objectives.
Always represent the Company in a professional manner and appearance.
Understand and internalize the Company's purpose.
Display loyalty to the Company and its organizational values.
Display enthusiasm and dedication to learning how to be more effective on the job and share knowledge with others.
Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner; listen to and objectively consider ideas and suggestions from others; keep commitments; keep others informed of work progress, timetables, and issues; address problems and issues constructively to find mutually acceptable and practical business solutions; address others by name, title, or other respectful identifier, and respect the diversity of our work force in actions, words, and deeds.
Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation.
Ensure conduct is consistent with all Compliance Program Policies and procedures when engaging in any activity on behalf of the company. Immediately report any concerns or violations.
Other duties as assigned.
Qualifications
Education, Knowledge, Skills, and Experience
Required Education:
Bachelor's degree in Business Administration, Information Systems, or a related field.
In lieu of a degree, four (4) additional years of directly related business analysis experience is required.
Required Knowledge:
Structured business analysis methodologies, including requirements elicitation, documentation, and validation.
Core concepts of enterprise IT systems, data flows, and system dependencies.
Agile and Waterfall project frameworks and their respective deliverables.
Understanding of data governance, privacy regulations, cybersecurity frameworks (e.g., HITRUST, HIPAA), disaster recovery planning, and audit controls affecting enterprise projects.
Preferred Knowledge:
Familiarity with governance frameworks and best practices for enterprise project execution.
Knowledge of data analysis techniques for evaluating workflow performance, solution impact, and adoption trends.
Experience with collaboration and project tools such as JIRA, Confluence, MS Project, and Visio.
Awareness of automation and data visualization platforms for enterprise reporting and process improvement.
Required Experience:
Minimum five (5) years of business analysis experience, including responsibility for defining requirements, supporting technical solution design, and coordinating across multiple stakeholder groups.
Minimum nine (9) years of experience required for candidates without a degree.
Preferred Experience:
Three (3) or more years of direct experience in enterprise-scale initiatives involving infrastructure or systems improvement, including direct participation in DR/BCP planning, compliance audits, and IT governance maturity efforts such as Change Management.
Two (2) or more years of experience in project coordination or project management functions.
Experience managing multi-vendor project deliverables, ensuring integration across diverse technology platforms.
Required Skills:
Ability to produce clear, detailed, and accurate documentation for technical and non-technical audiences.
Strong analytical and problem-solving capabilities, including the ability to evaluate complex dependencies and trade-offs.
Effective communication skills for facilitating decision-making among diverse stakeholders.
Exceptional organizational skills to manage and prioritize simultaneous projects, deadlines, and cross-functional dependencies.
Advanced presentation and reporting skills to communicate project impacts and progress to executive audiences.
Preferred Skills:
Competence with advanced reporting and visualization tools for metrics tracking and stakeholder reporting.
Experience working with external vendors and internal teams on multi-phase implementations.
Skills in change management techniques to support adoption of new processes and systems.
Ability to design system integration strategies to improve end-to-end business process performance.
Required Professional Certification:
None.
Preferred Professional Certification:
Certification in analytics, project management (e.g., CSPO, CAP, PMP-PBA, etc.), or equivalent.
Physical requirements
Vision, hearing, speech, movements requiring the use of wrists, hands and/or fingers. Must have the ability to view a computer screen for prolonged periods and the ability to sit for extended periods. Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled. Must have the ability to lift and maneuver items of at least 20 lbs. Must have the ability to travel occasionally. Working condition include normal office setting.
Mental Demands
Learning, thinking, concentration and the ability to work under pressure, particularly during busy times. Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service. Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations' situations. Must have the ability to exercise discretion as well as appropriate judgments when necessary. Must be proactive in finding solutions.
Direct Reports
No
EEO Statement
FFF Enterprises and Nufactor are an equal opportunity employer and prohibits discrimination and harassment based on the following characteristics: race, color, religion, national origin, physical or mental disability, gender, age (40 years and over) qualified veteran and any other characteristic protected by state or federal anti-discrimination law covering employment. These categories are defined according to Government Code section 12920. The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.
FP&A Analyst
Coppell, TX jobs
FP&A Analyst Are you ready to develop the future of retail? As the world's leader in IoT and data technologies for commerce, our mission is to help retailers and brands use digitalization to become more efficient, more intelligent, and more sustainable-and in doing so, enable more positive commerce.
VusionGroup is a fast-growing, fast-paced retail tech company. We believe that by thinking big and working together as one team-agile thinkers, tech makers, and change agents-we can build the largest retail IoT platform in the world.
Job Description
We build. We create impact.
The FP&A Analyst will play a key role in the North American region. You will report to the VP - Finance Americas and will be part of the FP&A team based in North America but with colleagues and stakeholders across multiple time zones.
This role is uniquely positioned to partner with the business to contribute significantly to the strategic planning and growth of the business.
This is a varied role in scope, entailing tracking and understanding daily/weekly/monthly financial performance, as well as producing monthly forecasts, reports, and annual budgets.
Lead and support the preparation of sales forecasts and budgeting processes in North American region. Work closely with sales and operation teams to ensure the alignment of financial plans with business objectives. Analyze historical trends, market conditions, and other relevant data to provide actionable insights for accurate sales forecasting.
Create strong business partnerships with various functions (Sales, operations, manufacturing…) and with a broad and diverse group of business partners, including C- levels and senior members of management. Provide guidance on financial implications of sales plans and recommend improvements for cost optimization and revenue growth.
Understand, impact, and influence business decisions through detailed financial analysis. Leverage data visualization techniques to present financial data in an easily digestible format for stakeholders at all levels. Define and report on KPIs for business partners, bringing insights to help inform strategic decisions.
Identify opportunities for streamlining sales planning, forecasting, and reporting processes. Implement best practices and continuous improvement initiatives to drive efficiency and accuracy in financial operations.
Perform monthly business reviews to provide team visibility, facilitate financial projections and provide value-added financial knowledge.
Collaborating with Accounting SSC in Paris to ensure proper monthly closing: cut-off entries, reconciliation of inventory positions with sales and purchasing, and accruals on calculated expenses.
Perform ad-hoc financial analysis and special projects as requested by senior leadership.
Qualifications
Qualification we're looking for:
Experience
:
2+ years of experience of relevant experience in FP&A or strategic finance, preferably at high growth, enterprise software, SaaS business with a strong focus on sales planning and forecasting.
Experience ideally with a combination of finance and operations experience (e.g., FP&A/ corporate finance, management consulting, or other highly analytical roles).
Skills:
Advanced excel skills, proficiency with ERP systems (SAP), Power BI, and financial modeling.
Analytical Skills: Ability to work independently, think objectively, and interpret meaningful and insightful narratives from both quantitative as well as qualitative data.
Abilities:
Financial and Business Acumen: Ability to evaluate financial and business indicators and translate as well as distill data into actionable information to drive results.
Ability to influence at all levels, including the most senior executives in the company, with a demonstrated aptitude to work effectively within a matrixed team across multiple functional areas and be assertive in driving successful management strategies.
Ability to manage multiple tasks in a deadline-driven environment while maintaining a high level of precision and accuracy.
Education:
Bachelor's degree in finance, accounting, economics or a related field.
We innovate. We help communities thrive.
VusionGroup has an international presence in 19 countries. In joining us, you'll be part of a globally distributed team of intellectually curious, committed, and collaborative co-workers.
The work is fast paced, challenging, and ambitious. Here, you will feel valued for your contributions as we reinvent modern commerce-together.
We feel supported. You will too.
VusionGroup is a place where people feel safe, happy, and respected. We offer programs and benefits to support you in whatever comes next in your life, including:
Generous paid time off (PTO
): 35 days PTO to enable work/life integration and promotes a culture of trust.
Health & Wellness
: Eligibility for benefits starting day one, plus retirement savings plans.
Financial future
: While retirement savings plans vary by country, we help you plan for your future.
Family-First Support
: Navigate family challenges with our assistance, securing time for both your loved ones and self-care.
Hybrid work
: Find your balance with two days working from home, three days in the office, plus the freedom to work anywhere for up to two weeks a year.
Time off to volunteer
and give back to your community.
Career Growth:
E-learning opportunities and workshops, and global mobility potential
Commute benefits
: up to $100/month per employee for commuting expenses.
Philanthropy
: Our company matches employee donations up to $500 per year for causes close to your heart.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Marketing Analytics Consultant
Dallas, TX jobs
About Client:
They help in transforming the leading organizations and communities around the world. Organizations infrastructure and culture is amazing. Best place!!
Job Title: Marketing Analytics Consultant
Job Level: Mid Level
Job Description:
This is what you will do..
You will be using quantitative methods to assess the impact of offline and digital marketing.
You will be interacting with the client.
You will be providing analyses, recommendations, presentations and advice to clients.
You will be doing project-based analytics which includes Marketing Mix Modeling, Multi-Channel Attribution, Digital Analytics, Pricing and Promotion and Demand Forecasting.
You will be leading a project team and you will be responsible for team's growth.
We are looking for someone...
Who has nearly 2+ years of experience in the analysis of Marketing data using SAS and other statistical modeling tools.
Who is good in providing external consulting.
Who is proficient in SAS or other statistical modeling tools.
Who enjoys traveling, because this role involves traveling (80% to 100%).
Who is proficient in Applied Statistics/Econometrics, Statistical Programming, Database Marketing Management & Operations etc.
Who is proficient in Customer-level data analysis.
Qualifications
Who has nearly 2+ years of experience in the analysis of Marketing data using SAS and other statistical modeling tools.
Who is good in providing external consulting.
Who is proficient in SAS or other statistical modeling tools.
Who enjoys traveling, because this role involves traveling (80% to 100%).
Who is proficient in Applied Statistics/Econometrics, Statistical Programming, Database Marketing Management & Operations etc.
Who is proficient in Customer-level data analysis.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Sr Consultant, Early Adopters
San Diego, CA jobs
SummaryThe Senior Early Adopter Consultant supports the Core Teams and SDS Teams by identifying success criteria for new products releases, identifying and securing the appropriate Early Adopters customers to validate the success criteria, managing customer engagements and closing out engagements at project completion .Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Senior Early Adopter Consultant supports the teams by identifying success criteria for new products releases, identifying and securing the appropriate Early Adopters customers to validate the success criteria, managing customer engagements and closing out engagements at project completion.
Competencies:
Strategic Thinking: ability to think through the customer engagement arenas and advise the core team or recommended approaches
Communication: Ensures the Core Team is informed of any customer requirements, dependencies, all customer feedback, barriers to recruitment for new projects
Communication: Ability to interact with customers at all levels, drive recruitment, and contract negotiation, and contract close-out.
Project Planning: Ability to act proactively and anticipate customer needs for new products including documentation, schedules, and BD staff requirements
Responsibilities:
Partner with a Readiness Consultant to define the Early Adopter rollout strategy for a new product. This strategy includes:
Extended Development Environment (XDE): A specialized setup that allows early users or developers to test and provide feedback before full release.
Development Partner: Identifying key partners who will work closely during the early stages to define the product.
LCR vs. Graduated GA Release: Deciding whether to launch via a Limited Customer Release (LCR) (a small, controlled rollout) or a Graduated General Availability (GA) release (a phased broader launch).
Hardware vs. Software considerations: Determining whether the rollout involves physical components (hardware), software, or both, and planning accordingly.
Facilitate Core Team alignment and approval on project success criteria, including target customer demographics, implementation, training, and service milestones.
Track and report progress against success criteria throughout the project lifecycle.
Manage customer contracting process as needed.
Serve as the primary customer contact to coordinate implementation resources and gather marketing feedback.
Identify and escalate product or process-related barriers to the Readiness Consultant and Core Team.
Conduct regular check-ins with Early Adopter customers, ensuring appropriate Core Team/BD participation and documentation.
Monitor contracts for expiration and extension requirements, if applicable.
Drive project close out including assignment to customer of any earned credits
Required Skills/Experience:
Bachelor's degree or 10+ years experience in Business, Marketing, Engineering, or Life Science
Two or more years' experience with new product introduction
Experience in customer service or customer account management in healthcare setting
Understand medication management processes in hospitals and health systems within the United States and Canada
Strong written and communication skills
Successful collaborator in a highly matrixed global organization
Strong project and time management skills
Knowledge of business processes for contracting
Experience working in an iterative fast-paced environment
Strong MS Office skills with emphasis on PowerPoint, Excel, and MS Project
Working knowledge of Jira and Confluence
Strong problem-solving, verbal, listening, and interpersonal skills
Ability to travel 25-30% as required for in-person customer meetings
Preferred Skills/Experience:
Bachelor Degree in Business, Marketing, STEM
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
.
Primary Work LocationUSA CA - San Diego Bldg A&BAdditional LocationsWork Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$109,700.00 - $180,800.00 USD Annual
Auto-ApplyVulnerability Management Consultant
Dallas, TX jobs
Candidates need to be technically proficient in various technologies and have excellent communication skills in order to effectively communicate possible vulnerabilities/issues to teams responsible for patching and remediation tracking. Some things to look for in resumes
Experience working with multiple vulnerability management solutions (Rapid7 Nexpose, Insight VM, Nessus, Tenable, and Qualys)
Experience managing patch processes and/or working with patching teams to drive remediation of identified vulnerabilities
Basic data analysis and visualization experience working through large and complex datasets in excel
ERWIN Governance Analyst
Dallas, TX jobs
Overview of project:
The resource will be working on implementing best practices and accelerating adoption of the tool. Client will use ERWIN for Metadata Management, implementing Centralized Data Dictionaries, and more usage as a DI product. Data Modeling is also in the horizon for later in 2021. Immediate need is around Data Governance using ERWIN
Skills Required:
2-3 years' experience with Erwin
Erwin Metadata management
Erwin Data Governance
Lab Technician - Technical Consultant
Tallahassee, FL jobs
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
To qualify, you must have:
+ **Bachelor's degree in Hard Science and 2 years of Lab Experience**
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Responsible for all Sample Processing job skills, including, preparing plasma units for freezing, preparing samples of plasma for testing, and preparing plasma units and samples for shipment.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day
activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
ACCOUNTABILITIES
Provide exceptional customer service to internal and external customers (5%)
Perform all required duties in the area of Sample Processing (including, but not limited to): (95%)
Prepare units for frozen storage.
Collect and store samples from plasma units for testing.
Perform routine maintenance on the freezer including monitoring freezer and refrigerator temperatures and removing ice buildup.
Prepare frozen plasma units and samples for shipping following established protocol.
Organize plasma boxes/documents for scheduled shipments and assist in loading shipments.
Manage supplies, assist management team with inventory control procedures, break down empty cartons and assist with proper disposal.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Ability to multi-task and work as a team player.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Good verbal communication and customer service skills.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs.
Must be able to occasionally work in a cold environment ranging from -20 C (-4 F) to -40 C (-40F).
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
DUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Experience in a laboratory, hospital, or other regulated environment is a plus
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
**BioLife Compensation and Benefits** **Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - FL - Tallahassee
**U.S. Hourly Wage Range:**
$22.19 - $30.51
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - FL - Tallahassee
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
No
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Sacramento, CA jobs
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities
Strategic CMC Leadership
- Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus)
- Support regulatory leads in developing contingency plans for CMC-related scenarios
- Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
- Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
- Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes
Cross-Functional Collaboration
- Partner with manufacturing, quality, and external organizations to address CMC-related issues
- Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
- Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
- Identify and implement process improvements to enhance regulatory efficiency and readiness
- Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
- Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
- Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus
- Ensure audit readiness and version control through meticulous documentation and system management
Qualifications
Experience & Expertise
- 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
- Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
- In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus!
Skills & Attributes
- Strategic and proactive mindset with strong operational execution
- Excellent analytical, problem-solving, and negotiation skills
- Effective communicator with strong interpersonal, presentation, and leadership abilities
- Ability to manage multiple projects independently in a matrixed, multicultural environment
- Proficiency in Microsoft Office Suite and regulatory systems
Education
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
- RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Senior / Regulatory Affairs Consultant - Advertising and Promotion
Sacramento, CA jobs
We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust.
Key Responsibilities
- Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content.
- Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development.
- Participate in promotional review committees, ensuring alignment with FDA regulations and company standards.
- Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements.
- Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations.
- Support preparation of responses to regulatory inquiries related to promotional activities.
- Track and manage promotional submissions and approvals in regulatory systems
- Manage SOPs and electronic review systems.
Qualifications
- Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
Experience:
- 3-5 years of pharmaceutical/biotech related industry experience.
- Direct experience in advertising and promotional regulatory review.
- Familiarity with FDA regulations governing promotional materials.
Skills:
- Strong organizational skills with the ability to manage multiple projects under tight timelines.
- Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners.
- Attention to detail combined with strategic thinking.
- Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS).
- Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards.
Competencies:
- Knowledge of US regulatory requirements for advertising and promotion.
- Demonstrated problem-solving ability and sound decision-making.
- Ability to work effectively in a matrix environment and collaborate across diverse teams.
- Strong interpersonal skills with cross-cultural awareness.
- Fluency in English (verbal and written).
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Rebate Analyst
Lake Zurich, IL jobs
Job SummaryThe Rebate Analyst is responsible for providing analytical support primarily to the Finance, Sales, National Accounts & Commercial Contracting and Analysis groups and assigned customers to include, but not limited to GPOs, National Accounts, IDNs, and Managed Care organizations. This includes contract sales analysis and reporting, rebates and administrative fee analysis and payments, contract and compliancy analysis, special rebate programs, and additional analytical support as required.
Salary Range: $71,505 - $75,600 per year
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.Responsibilities
Provides ad hoc reports to management regarding GPO, IHN, and National Account customers as required.
Administers tracks, calculates and processes rebate payments, administrative fees, tiered programs and compliance program payments to key national GPO customers, distributors and assigned National Accounts within the Model N system for Pharma, Biosimilar, Managed Care and Infusions Technology products. Reviews payments for completeness and accuracy. Enters rebate programs into Model N. Runs and provides printed and electronic fee and rebate reports for customers including custom customer reports or ad hoc reports.
Trend analysis on payment packages paid over prior contract periods and sales history. Reviews, approves, and implement new rebate programs and amendments within Model N.
Daily reconciliation of rebate payments to ensure accurate payment to wholesaler and/or GPO.
Assists in the accrual reports and internal and external audits for the Finance Department.
Administers, calculates, tracks and processes Oncology Rebate Programs for key oncology distributor customers.
Interacts with IT to create, design, redesign and improve standard management sales reports. Manages the IT ticket and project request database for the team.
Acts as SME (subject matter expert) for the Model N system. Trains, problem solves, and provides department expertise on Model N system.
Works with customers, wholesalers, and functional groups within Fresenius Kabi to process contract eligibility according to company and department SOPs and procedures including class of trade review.
Reviews and analyzes memberships and contract eligibility for various GPO's at Fresenius Kabi as required.
Manage and Process all new rebate programs and rebate amendments to all wholesalers via excel and email.
Communicates directly with all wholesalers regarding contract pricing and eligibility and requests for contract information.
Collaborate with both internal and external auditors to provide contract documentation and information as requested and required.
Files all contract documents according to department and company SOPs. Prepares contract files for Records Retention.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements
Bachelor's degree preferred, preferably in Business or Finance, and a minimum of 3 years related work experience.
1+ years in the pharmaceutical, life sciences, medical device or biotech industry highly desired.
Knowledge of GPOs, Managed Care, IDNs, Payer, Biosimilar and Wholesaler experience highly preferred.
Ability to interface effectively with all groups and teams and within all levels of the organization.
Strong marketing and sales orientation.
Excellent verbal and written communication skills.
Excellent Excel, PC, analytical, and organizational skills.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Auto-ApplyCMC Regulatory Affairs Senior/Consultant - Small Molecules
Jefferson City, MO jobs
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities
Strategic CMC Leadership
- Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus)
- Support regulatory leads in developing contingency plans for CMC-related scenarios
- Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
- Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
- Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes
Cross-Functional Collaboration
- Partner with manufacturing, quality, and external organizations to address CMC-related issues
- Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
- Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
- Identify and implement process improvements to enhance regulatory efficiency and readiness
- Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
- Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
- Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus
- Ensure audit readiness and version control through meticulous documentation and system management
Qualifications
Experience & Expertise
- 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
- Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
- In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus!
Skills & Attributes
- Strategic and proactive mindset with strong operational execution
- Excellent analytical, problem-solving, and negotiation skills
- Effective communicator with strong interpersonal, presentation, and leadership abilities
- Ability to manage multiple projects independently in a matrixed, multicultural environment
- Proficiency in Microsoft Office Suite and regulatory systems
Education
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
- RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Senior / Regulatory Affairs Consultant - Advertising and Promotion
Springfield, IL jobs
We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust.
Key Responsibilities
- Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content.
- Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development.
- Participate in promotional review committees, ensuring alignment with FDA regulations and company standards.
- Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements.
- Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations.
- Support preparation of responses to regulatory inquiries related to promotional activities.
- Track and manage promotional submissions and approvals in regulatory systems
- Manage SOPs and electronic review systems.
Qualifications
- Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
Experience:
- 3-5 years of pharmaceutical/biotech related industry experience.
- Direct experience in advertising and promotional regulatory review.
- Familiarity with FDA regulations governing promotional materials.
Skills:
- Strong organizational skills with the ability to manage multiple projects under tight timelines.
- Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners.
- Attention to detail combined with strategic thinking.
- Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS).
- Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards.
Competencies:
- Knowledge of US regulatory requirements for advertising and promotion.
- Demonstrated problem-solving ability and sound decision-making.
- Ability to work effectively in a matrix environment and collaborate across diverse teams.
- Strong interpersonal skills with cross-cultural awareness.
- Fluency in English (verbal and written).
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Springfield, IL jobs
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities
Strategic CMC Leadership
- Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus)
- Support regulatory leads in developing contingency plans for CMC-related scenarios
- Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
- Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
- Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes
Cross-Functional Collaboration
- Partner with manufacturing, quality, and external organizations to address CMC-related issues
- Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
- Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
- Identify and implement process improvements to enhance regulatory efficiency and readiness
- Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
- Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
- Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus
- Ensure audit readiness and version control through meticulous documentation and system management
Qualifications
Experience & Expertise
- 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
- Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
- In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus!
Skills & Attributes
- Strategic and proactive mindset with strong operational execution
- Excellent analytical, problem-solving, and negotiation skills
- Effective communicator with strong interpersonal, presentation, and leadership abilities
- Ability to manage multiple projects independently in a matrixed, multicultural environment
- Proficiency in Microsoft Office Suite and regulatory systems
Education
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
- RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Senior / Regulatory Affairs Consultant - Advertising and Promotion
Tallahassee, FL jobs
We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major client engagement. In this role, you will partner with cross-functional teams to ensure that all promotional, marketing, educational, and social media materials comply with US regulatory requirements. You'll play a key role in supporting product launches, campaigns, and ongoing promotional activities while safeguarding compliance and patient trust.
Key Responsibilities
- Review and approve advertising and promotional materials, including direct-to-consumer campaigns, medical education, and social media content.
- Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal) during promotional material development.
- Participate in promotional review committees, ensuring alignment with FDA regulations and company standards.
- Collaborate with global teams to ensure consistency across markets while meeting US-specific requirements.
- Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations.
- Support preparation of responses to regulatory inquiries related to promotional activities.
- Track and manage promotional submissions and approvals in regulatory systems
- Manage SOPs and electronic review systems.
Qualifications
- Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
Experience:
- 3-5 years of pharmaceutical/biotech related industry experience.
- Direct experience in advertising and promotional regulatory review.
- Familiarity with FDA regulations governing promotional materials.
Skills:
- Strong organizational skills with the ability to manage multiple projects under tight timelines.
- Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional partners.
- Attention to detail combined with strategic thinking.
- Proficiency with Microsoft Office and regulatory systems (e.g., Veeva PromoMats, eDMS).
- Ability to create and revise Ad/Promo SOPs to ensure promotional materials are updated as required by FDA regulations and company standards.
Competencies:
- Knowledge of US regulatory requirements for advertising and promotion.
- Demonstrated problem-solving ability and sound decision-making.
- Ability to work effectively in a matrix environment and collaborate across diverse teams.
- Strong interpersonal skills with cross-cultural awareness.
- Fluency in English (verbal and written).
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
CMC Regulatory Affairs Senior/Consultant - Small Molecules
Tallahassee, FL jobs
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities
Strategic CMC Leadership
- Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus)
- Support regulatory leads in developing contingency plans for CMC-related scenarios
- Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
- Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
- Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes
Cross-Functional Collaboration
- Partner with manufacturing, quality, and external organizations to address CMC-related issues
- Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
- Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
- Identify and implement process improvements to enhance regulatory efficiency and readiness
- Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
- Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
- Experience with CPP application filing via eCATS and 510(j)(3) reporting through next Gen portals is a plus
- Ensure audit readiness and version control through meticulous documentation and system management
Qualifications
Experience & Expertise
- 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
- Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
- In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus!
Skills & Attributes
- Strategic and proactive mindset with strong operational execution
- Excellent analytical, problem-solving, and negotiation skills
- Effective communicator with strong interpersonal, presentation, and leadership abilities
- Ability to manage multiple projects independently in a matrixed, multicultural environment
- Proficiency in Microsoft Office Suite and regulatory systems
Education
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field
- Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
- RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
\#LI-LB1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Professional Aesthetic Consultant - Chicago North
Consultant job at Revance Therapeutics
The Professional Aesthetic Consultant (PAC) promotes the product portfolio to targeted aesthetic customers within a designated geographical area. This role will create product acceptance and enhancing portfolio growth through various business development activities. The PAC provides technical product and procedure expertise.
Reporting to: Regional Sales Director
Territory: Chicago North
Salary Range: *$90,000 to $105,000 annually + uncapped commission
*The final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education, and geographic location.
Responsibilities/Essential Duties:
Strategically manage the territory to meet or exceed sales objectives.
Responsible for lead generation through direct contact with customers in an assigned area.
Maintains effective customer relations, develops opportunities for growth within an existing customer base, and assures market penetration and profitability while achieving sales forecasts.
Deliver sales results per assigned quarterly goal and have primary responsibility for area metrics, issues, and customers.
Maintain a pipeline of opportunities to meet or exceed sales objectives.
Provide and filter key market insights back to sales and marketing management.
Maintain accurate reporting, records, and files necessary for proper management of territory.
Positively represent Revance throughout customer locations.
Actively participate in sales meetings, conference calls, and other necessary business meetings.
Demonstrate honesty and integrity while modeling behaviors consistent with company standards and adhere to all sales policies and procedures.
Basic Qualifications:
Bachelor's degree
Minimum 2 years of outside sales experience in the Medical or Aesthetics industry
Preferred Qualifications:
5+ years of sales/account management experience
History of meeting and exceeding sales objectives
Experience in medical aesthetics, dermatology, or plastic surgery
Launch experience
Experience in buy and bill or cash pay medicine
Possess advanced business acumen; understands competitors, influencers, industry trends
Ability to work in a launch or fast-paced, highly visible and dynamic environment
Strong knowledge of analytics, budgeting and key revenue drivers; able to leverage data to target and prioritize opportunities
Demonstrate perseverance; resiliency and positive, ‘can-do' attitude
Possess a “self-starter,” entrepreneurial spirit with extreme accountability/ownership for territory results
Advanced presentation skills; ability to engage and meet the needs of various audiences
Company Summary:
Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you:
Competitive Compensation including base salary and commission
Flexible unlimited PTO, holidays, and parental leave
Generous healthcare benefits, Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more
This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Auto-ApplyPLM Analyst
Houston, TX jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.
Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
Job Description
The PLM Analyst prepares and analyzes environmental samples according to the required methodology and company compliance. As an analyst you will gain experience of both job-specific routine and complex analyses. The analyst team also validates and reviews data for accuracy, uploads laboratory data into the LIMS system, and ultimately will prepare and generate required reports to our clients. As a member of our analyst team you will also oversee sample scheduling and work to meet sample due dates and hold times.
Analyst responsibilities include, but are not limited to, the following:
* Prepare and analyze environmental samples
* Accurately enters and reports analytical data using the LIMS
* Performs independent data reviews for other analysts' work
* Performs analysis of reference materials, proficiency samples and other quality control samples as needed
* Provides high-level client service and technical support as needed
* Assists the QA manager in development, implementation and data collection of QA processes for the different analytical tests
* Performs confirmation of lab results as requested by client services personnel
* Performs and completes all analytical testing QA related tasks as requested
* Assists in pursuing, receiving and maintaining necessary laboratory accreditations
* Maintains and updates all necessary Training and QA documents onsite as necessary
* Co-ordinates and manages projects according to their rush status and due time for timely delivery
* Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed
* Manages and disposes analyzed samples as needed
* Recommends and coordinates sample transfer as necessary
* Establishes and maintains laboratory stock culture and reference samples
* Performs root cause analysis and determines and implements corrective actions for errors and issues as necessary
* Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed
* Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed
Qualifications
Basic Minimum Qualifications:
* BS or BA in a closely related science plus 1-2 years of laboratory experience
* Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess:
* Environmental methodologies
* General regulatory requirements
* Analytical laboratory techniques
* Laboratory QA requirements
* Knowledge of computers, spreadsheets, and databases
* Strong computer, scientific, and organizational skills
Additional Information
Candidates located within commutible distance of Houston, TX are eligible to apply. This role is a full time opportunity. Monday - Friday 8 AM- 5 PM
This role has a salary range of $20-22 an hour with health, dental and vision benefits as well as a company matching 401K plan and PTO plan.
Professional working proficiency in English is a requirement, including the ability to read, write and speak in English
Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business section, and geographic location
We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development.
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.
Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!
Find out more in our career page: *****************************
Eurofins Environment Testing Businesses in the US are routinely engaged in Federal Contracts. Federal Government vaccination mandates may apply to staff working in these businesses. Successful applicants may be required to confirm vaccination status or demonstrate eligibility for medical or religious exemptions prior to commencing employment. In addition, certain positions require travel for which vaccination is required in accordance with Eurofins policy.
Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
PLM Analyst
Houston, TX jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.
Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
Job Description
The PLM Analyst prepares and analyzes environmental samples according to the required methodology and company compliance. As an analyst you will gain experience of both job-specific routine and complex analyses. The analyst team also validates and reviews data for accuracy, uploads laboratory data into the LIMS system, and ultimately will prepare and generate required reports to our clients. As a member of our analyst team you will also oversee sample scheduling and work to meet sample due dates and hold times.
Analyst responsibilities include, but are not limited to, the following:
Prepare and analyze environmental samples
Accurately enters and reports analytical data using the LIMS
Performs independent data reviews for other analysts' work
Performs analysis of reference materials, proficiency samples and other quality control samples as needed
Provides high-level client service and technical support as needed
Assists the QA manager in development, implementation and data collection of QA processes for the different analytical tests
Performs confirmation of lab results as requested by client services personnel
Performs and completes all analytical testing QA related tasks as requested
Assists in pursuing, receiving and maintaining necessary laboratory accreditations
Maintains and updates all necessary Training and QA documents onsite as necessary
Co-ordinates and manages projects according to their rush status and due time for timely delivery
Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed
Manages and disposes analyzed samples as needed
Recommends and coordinates sample transfer as necessary
Establishes and maintains laboratory stock culture and reference samples
Performs root cause analysis and determines and implements corrective actions for errors and issues as necessary
Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed
Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed
Qualifications
Basic Minimum Qualifications:
BS or BA in a closely related science plus 1-2 years of laboratory experience
Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess:
Environmental methodologies
General regulatory requirements
Analytical laboratory techniques
Laboratory QA requirements
Knowledge of computers, spreadsheets, and databases
Strong computer, scientific, and organizational skills
Additional Information
Candidates located within commutible distance of Houston, TX are eligible to apply. This role is a full time opportunity. Monday - Friday 8 AM- 5 PM
This role has a salary range of $20-22 an hour with health, dental and vision benefits as well as a company matching 401K plan and PTO plan.
Professional working proficiency in English is a requirement, including the ability to read, write and speak in English
Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business section, and geographic location
We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development.
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.
Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!
Find out more in our career page: *****************************
Eurofins Environment Testing Businesses in the US are routinely engaged in Federal Contracts. Federal Government vaccination mandates may apply to staff working in these businesses. Successful applicants may be required to confirm vaccination status or demonstrate eligibility for medical or religious exemptions prior to commencing employment. In addition, certain positions require travel for which vaccination is required in accordance with Eurofins policy.
Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
Mold Analyst
Houston, TX jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.
Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
Job Description
The Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP's, and must be knowledgeable of both job-specific routine
and complex analyses.
Essential Duties and Responsibilities:
* Prepare and analyze environmental samples
* Accurately enters and completes reporting using the LIMS
* Performs independent reviews for other analysts' work
* Performs analysis of reference materials, proficiency samples and other quality control samples as needed
* Maintains client service and provides technical support as needed
* Assists the Quality Assurance (QA) manager in development, implementation and data collection of QA processes for the different analytical tests
* Performs confirmation of lab results as needed by client services personnel
* Performs and completes all analytical testing QA related tasks as needed
* Assists in pursuing, receiving and maintaining necessary laboratory accreditation
* Maintains and updates all necessary Training and QA documents onsite as necessary
* Co-ordinates and manages projects according to their rush status and due time for timely delivery
* Assists co-workers on analytical questions, as necessary
* Participates in Lean initiatives and projects when called upon
* Follows company policies and procedures
* Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed
* Manages and disposes analyzed samples as needed
* Trains new mycology or bacteriology or asbestos or other analytical testing Analysts as needed
* Recommends and coordinates sample transfer as necessary
* Establishes and maintains laboratory stock culture and reference samples
* Performs root cause analysis and determines and implements corrective actions for errors and issues as necessary
* Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed
* Routinely communicates available capacity to senior management
* Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed
* Other responsibilities as deemed necessary by the Supervisor/Manager
Qualifications
* BS or BA in a closely related science
* Authorization to work in the United States indefinitely without restriction or sponsorship
* Professional working proficiency in English is a requirement, including the ability to read, write and speak in English
Experience:
* 1-2 years work laboratory experience
* Environmental methodologies
* General regulatory requirements
* Analytical laboratory techniques
* Laboratory QA requirements
* Knowledge of computers, spreadsheets, and databases
Additional Information
Position is full-time, Monday-Friday 9:00 AM- 6:00 PM, with weekend rotation as needed.
Position starting pay range is $21.00 /hr.
Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business sector, and geographic location.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options.
We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development.
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.
Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!
Find out more in our career page: *****************************
Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.