Center Manager for Plasma Donation Center
Moreno Valley, CA jobs
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Job Title: CENTER MANAGER
Summary:
Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation. Works under general occasional guidance and general oversight of regional management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations.
Primary Responsibilities for Role:
Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals.
Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership.
Operates the center and manages employees and operations to the highest standard of ethics and integrity.
Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency.
Directs and manages employees.
Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements.
Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes.
Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records.
Provides strategic direction and planning.
Other Responsibilities for Role:
Acts as a mentor to assigned team, other center staff and other centers.
Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion.
Accountable to ensure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards.
Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed.
Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order.
Accountable for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately.
Submit timely and accurate reports on a daily/weekly basis or as requested.
Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors.
Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).
Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met.
Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.
Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure.
Control center donor funds and ensure that all financial records are accurate and in order.
Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action.
Minimize center liability through constant risk management review. Investigates all unsafe situations and complaints and institutes corrective/preventive action.
Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises.
Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence.
Performs other duties as required.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Job Requirements:
Bachelor's degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field.
Typically requires a minimum of 3 years of related work experience in clinical or general business environment.
Supervisory experience preferred but not required.
Prior management experience, preferably supervising a group of 20 or more employees.
Experience in a medical and/or cGMP regulated environment preferred.
Experience with plasma or whole blood preferred.
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master's degree with 2 years of experience.
Attributes:
Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills. Ability to understand, assess and communicate FDA regulations. Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards. Ability to control costs and maintain a budget. Ability to motivate staff to achieve established goals and standards. Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations. Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance. Ability to relocate preferred.
Compensation and Benefits:
This position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
“We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.”
#BiomatUSA
#Indeed
#app
#LI-Onsite
#LI-BA1
#LI-RL1
Third Party Agency and Recruiter Notice:
Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-Moreno Valley
Center Address: 718 22nd Ave South, Brookings, SD 57006
Contact: Alex S. Contreras,
Senior Talent Acquisition Partner
- ************** | **********************
Learn more about Grifols
Follow us on Facebook: *******************************************
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To find more jobs with Grifols: ********************
Or Text GRIFOLS to ************
Director, Pharmaceutical Global Advertising & Promotion
King of Prussia, PA jobs
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Director, Global Advertising and Promotion? The job is in our King of Prussia, PA office or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to the Executive Director, Head, Global Labeling & Labeling Data Strategy.
The Director, Global Advertising and Promotion is responsible for developing and overseeing the regulatory strategy and compliance of promotional and non-promotional with a global focus. This role ensures that all advertising, promotional, and external communications activities for markets ex-US comply with applicable regulations, guidelines, and company policies. The incumbent will provide leadership across regions (e.g., EU, APAC, LATAM) and collaborate with cross-functional partners including Marketing, Legal, Medical Affairs, and Commercial to drive compliant and innovative messaging that satisfies regulatory requirements while meeting strategic corporate and business objectives.
Main Responsibilities & Accountabilities
•Strategic Leadership:
Provide global oversight, leadership and direction to develop and execute global regulatory ad/promo strategies to support product commercialization, lifecycle management, and expansion into new markets.•Regulatory Review & Compliance:
Participate in the review and approval process for promotional and non-promotional materials (e.g., websites, social media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (e.g., EMA, PMDA).•Regulatory Authority Interaction:
Serve as the primary point of contact with regulatory bodies on advertising and promotion matters, including submission of materials to Health Authorities, responding to inquiries, and managing enforcement risk.•Cross-functional Collaboration:
Partner with Legal, Compliance, Medical, and Commercial teams to ensure accurate and balanced content in alignment with product labeling and company strategy.•Policy and SOP Development:
Lead the development and implementation of global policies, standard operating procedures (SOPs), and training programs for advertising and promotional review processes.•Team Leadership:
Build and manage a high-performing global ad/promo team of reviewers. Provide mentorship, professional development, and performance management.•Risk Assessment:
Identify and mitigate regulatory risks in promotional materials and campaigns. Provide guidance during concept development and campaign planning phases.•Innovation Enablement:
Support the integration of digital and emerging media in advertising strategies while maintaining compliance.
Qualifications & Experience Requirements
Bachelor's degree required.•8+ years of Regulatory Affairs experience, with at least 6+ years specifically in advertising and promotion within the pharmaceutical, biotechnology, or healthcare industry.•In-depth knowledge of global regulatory requirements and guidances (e.g., EMA, Health Canada).•Experience with regulatory submissions for promotional materials •Proven leadership skills in managing teams, projects, and cross-functional collaborations.#LI-HYBRIDOur Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Senior Manager, Targeting
King of Prussia, PA jobs
The Senior Manager, Targeting will be responsible for leading the design, implementation, and ongoing management of sales force targeting and alignment processes for US sales forces. This role will ensure that customer segmentation, call planning, and territory alignments are executed with precision to optimize field effectiveness and support brand and corporate strategies.
The position requires strong analytical, operational, and cross-functional collaboration skills to ensure that targeting strategies are aligned with business objectives and are executed in a compliant and efficient manner. The Senior Manager will partner closely with Sales, Marketing, and other I&A teams to provide actionable insights and operational excellence in targeting and alignment.
Responsibilities:
Lead the targeting and alignment strategy for three US sales forces, ensuring optimal customer coverage and resource deployment.
Manage the execution of territory alignment processes, including design, updates, and communication to field leadership.
Partner with brand and field leadership to translate strategy into actionable customer segmentation and call planning.
Conduct geographic and customer-level analyses to identify market opportunities and optimize field force allocation.
Collaborate with cross-functional partners to develop, test, and enhance targeting methodologies, tools, and business rules.
Support periodic alignment refreshes and special projects (e.g., new product launches, resourcing shifts, field force expansion).
Build and maintain processes to ensure accurate, timely, and transparent communication of targeting changes to the field.
Develop reporting and dashboards to monitor territory performance and targeting effectiveness.
Ensure compliance with corporate, legal, and regulatory requirements in all targeting and alignment processes.
Qualifications:
7+ years of experience in pharmaceutical or biotech commercial operations, analytics, or sales force operations.
Hands-on expertise in sales force targeting, segmentation, and territory alignment.
Strong analytical and problem-solving skills with ability to manage large, complex data sets.
Experience with targeting/alignment software platforms and field deployment tools preferred.
Excellent communication and collaboration skills with ability to interact effectively with senior stakeholders and field leadership.
Demonstrated ability to manage multiple projects and deliver results under tight timelines.
Knowledge of US pharmaceutical commercial, legal, and compliance environment.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Senior Project Manager, Portfolio Delivery
King of Prussia, PA jobs
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Senior Project Manager, Portfolio Delivery? The job is in our King of Prussia, PA or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the TA Portfolio Delivery Lead.
You will lead the successful operational delivery of global R&D projects of strategic importance to CSL's product portfolio.
The Role
You will work with project leader to define strategy and operational tactics
Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation
Accountable for the accuracy and quality of reports to senior stakeholders
Lead development teams through tactical execution of project plans
Manage and resolve project issues and reduce risks
Ensure documentation of main team information, actions, modifications to scope, resources, timelines and milestones in project management systems is current.
Evaluate the project planning, scenarios and challenge assumptions to increase robustness of project plans
Monitor performance vs. plan (budget and timeline)
Coordinate program updates to Sr. Management
Provide coaching to more junior members of the R&D Global Project Management Department
Qualifications
Bachelor's degree or equivalent in Science, Engineering, or a related field.
Project Management Professional (PMP) certification,
7+ years' experience in the biotechnology or pharmaceutical industry
5+ years' experience as a project manager leading project teams in a matrixed, global environment, In-depth knowledge in drug research, development and manufacturing processes
Demonstrated experience delivering projects to meet our goals on time, within budget and wit quality.
BENEFITS
Medical, Dental Vision
401K
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Area Manager, Specialty Northeast NYC, CT
Hartford, CT jobs
Northeast region- NYC
The Area Manager is responsible for promotion and utilization of CSL Behring products and for managing all aspects of territory business development. Area Manager will cultivate and maintain relationships with key customers to include: Health Care Professionals (HCP), hospital decision makers/influencers, specialty pharmacies and distribution channel partners. Area Manager will create demand for promoted products while demonstrating strong clinical knowledge. Area manager should demonstrate a high level of business acumen to facilitate the development of new accounts while supporting the growth of existing accounts. Area Managers will be expected to support appropriate patient education programs as needed.
Main Responsibilities and Accountabilities:
Promote products and increase usage of products to select call points, including HCP's, hospitals, hemophilia treatment centers, patient support groups, distributors and/or specialty pharmacies. Develops customer advocates for promoted products.
Responsible for the development of new accounts and the growth of existing accounts through solid customer relationships, communication of technical product and disease state information, and effective territory management skills.
Develop and implement territory business plans consistent with corporate direction designed to achieve/exceed territory sales targets. Appropriate knowledge of product features and benefits, competitive products and programs and distribution channels.
Implement key marketing programs to increase market share of key promoted products.
Maintain proper call frequency with assigned targets and update as needed to assure time is aligned with current product focus.
Stay abreast of current clinical technical literature from medical journals and other information sources.
Implement CSL selling model (PS2) with effective opening, probing, listening, and closing skills on customer calls.
Actively work with patient support groups where appropriate, following CSL Behring SOP's.
Stay abreast of pertinent marketplace issues and opportunities and effectively communicates them to manager.
Represent CSL Behring at local customer meetings as appropriate to increase exposure of CSL Behring products and services.
Regular travel required which may include weekends for select customer or corporate meeting and events.
Qualifications:
• Bachelor degree in a scientific or business field
• Minimum of five years' pharmaceutical sales or required relevant experience
• Demonstrated success with field sales and market share growth
• Knowledge of the pharmaceutical market and regulations
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
The expected base salary range for this position at hiring is $120K - $135K Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role will also include sales incentive compensation and may include equity.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Area Manager, Specialty Northeast
Hartford, CT jobs
Northeast region- Manchester
The Area Manager is responsible for promotion and utilization of CSL Behring products and for managing all aspects of territory business development. Area Manager will cultivate and maintain relationships with key customers to include: Health Care Professionals (HCP), hospital decision makers/influencers, specialty pharmacies and distribution channel partners. Area Manager will create demand for promoted products while demonstrating strong clinical knowledge. Area manager should demonstrate a high level of business acumen to facilitate the development of new accounts while supporting the growth of existing accounts. Area Managers will be expected to support appropriate patient education programs as needed.
Main Responsibilities and Accountabilities:
Promote products and increase usage of products to select call points, including HCP's, hospitals, hemophilia treatment centers, patient support groups, distributors and/or specialty pharmacies. Develops customer advocates for promoted products.
Responsible for the development of new accounts and the growth of existing accounts through solid customer relationships, communication of technical product and disease state information, and effective territory management skills.
Develop and implement territory business plans consistent with corporate direction designed to achieve/exceed territory sales targets. Appropriate knowledge of product features and benefits, competitive products and programs and distribution channels.
Implement key marketing programs to increase market share of key promoted products.
Maintain proper call frequency with assigned targets and update as needed to assure time is aligned with current product focus.
Stay abreast of current clinical technical literature from medical journals and other information sources.
Implement CSL selling model (PS2) with effective opening, probing, listening, and closing skills on customer calls.
Actively work with patient support groups where appropriate, following CSL Behring SOP's.
Stay abreast of pertinent marketplace issues and opportunities and effectively communicates them to manager.
Represent CSL Behring at local customer meetings as appropriate to increase exposure of CSL Behring products and services.
Regular travel required which may include weekends for select customer or corporate meeting and events.
Qualifications:
• Bachelor degree in a scientific or business field
• Minimum of five years' pharmaceutical sales or required relevant experience
• Demonstrated success with field sales and market share growth
• Knowledge of the pharmaceutical market and regulations
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Area Manager, Immunology MidSouth KY
Hartford, CT jobs
Territory: Louisville, Kentucky
The Area Manager is responsible for promotion and utilization of CSL Behring products and for managing all aspects of territory business development. Area Manager will cultivate and maintain relationships with key customers to include: Health Care Professionals (HCP), hospital decision makers/influencers, specialty pharmacies and distribution channel partners. Area Manager will create demand for promoted products while demonstrating strong clinical knowledge. Area manager should demonstrate a high level of business acumen to facilitate the development of new accounts while supporting the growth of existing accounts. Area Managers will be expected to support appropriate patient education programs as needed.
Main Responsibilities and Accountabilities:
Promote products and increase usage of products to select call points, including HCP's, hospitals, patient support groups, distributors and specialty pharmacies. Develops customer advocates for promoted products.
Responsible for the development of new accounts and the growth of existing accounts through solid customer relationships, communication of technical product and disease state information, and effective territory management skills.
Develop and implement territory business plans consistent with corporate direction designed to achieve/exceed territory sales targets. Appropriate knowledge of product features and benefits, competitive products and programs and distribution channels.
Implement key marketing programs to increase market share of key promoted products.
Maintain proper call frequency with assigned targets and update as needed to assure time is aligned with current product focus
Stay abreast of current clinical technical literature from medical journals and other information sources.
Implement CSL selling model (PS2) with effective opening, probing, listening, and closing skills on customer calls.
Actively work with patient support groups where appropriate, following CSL Behring SOP's.
Stay abreast of pertinent marketplace issues and opportunities and effectively communicates them to manager.
Represent CSL Behring at local customer meetings as appropriate to increase exposure of CSL Behring products and services.
Regular travel required which may include weekends for select customer or corporate meeting and events.
Qualifications:
Bachelor degree in a scientific or business field
Minimum of five years' pharmaceutical sales or required relevant experience.
Experience with patient groups, specialty pharmacies and distributors a plus.
Ability to demonstrate effective management of a large geography desired.
CSL offers the following benefits for this full-time position, all are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
Director, Global Market Access
Boston, MA jobs
Greater Boston or Greater Philadelphia (on-site 3 days a week)
A Specialty Pharmaceutical company in a hyper-growth mode with a recent, successful US launch is seeking an experienced Global Market Access individual to join their team in preparation for their global launch. This position will be crucial in driving both the strategic and operational aspects of market access strategy, pricing, payer acceptance, and strategic payer market research to drive patient outcomes on an international scale.
Responsibilities:
Develop and execute global market access and payer strategies by designing integrated approaches, aligning with lifecycle management, and ensuring pricing, access, and funding objectives are met across regions.
Lead comprehensive market/payer research including analog assessments, health technology appraisal outcomes, and burden-of-disease analysis to inform pricing estimates, evidence packages, and target product profiles.
Support strategic decision-making for portfolio and pipeline by providing insights on market access potential, shaping value propositions, and proactively mitigating risks from evolving policy reforms and competitive landscapes.
Drive cross-functional collaboration with multiple teams, including HEOR, Marketing, Medical Affairs, Public Affairs, and regional teams to ensure robust value propositions and alignment with global brand strategies.
Enable global implementation and capability building through market access strategy training, ensuring consistency and readiness across all teams.
Qualifications:
12+ years relevant experience in the pharmaceutical industry, and requiring 6+ years in Global Market Access, preferably with direct exposure to European Markets.
Proven track record in shaping strategies for patient access, pricing, and reimbursement while anticipating industry trends and market dynamic.
Strong analytical and financial skills combined with the ability to communicate effectively through presentations and stakeholder engagement at senior levels.
Looking for someone with an entrepreneurial mindset who is ready to drive impact and accomplish objectives swiftly and urgently.
Must be able to travel up to 30%
If you are ready to take the next step with a fast-paced, growing pharma with an exciting product and pipeline, this could be a great fit. Unlock your next career achievement by applying here, and a dedicated recruiter will be in touch!
Director, Congress & Medical Education Strategy & Execution - Neph & Immuno
Princeton, NJ jobs
The Director, Congress and Medical Education Strategy & Execution is responsible for developing and leading the global medical strategy and tactical execution for congresses and medical education, spearheading Otsuka's non-promotional scientific communication initiatives across the diverse Nephrology and Immunology portfolio.
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This role drives scientific engagement through impactful congress strategies & execution educational programs, and evidence-based content that support Otsuka's mission to improve patient outcomes through deep scientific understanding and collaborative partnerships.
The Director partners closely with global and regional cross-functional stakeholders - including Global Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I) and Commercial, to ensure scientific alignment, operational excellence and consistency in Otsuka's external scientific exchange.
Job Description
Key Responsibilities Include:
Congress Strategy and Execution
Lead development and execution of comprehensive multi-year medical congress strategy for Nephrology and Immunology aligned with Otsuka's pipeline and product lifecycle stages , including prioritization of key international and regional congresses, scientific communication objectives, symposia, booth presence, and internal/external engagement activities
Collaborate with Medical Strategy, Medical Communications, Field Medical and Medical Information to develop high-quality, scientifically rigorous presentation and materials; ensuring data dissemination plans are timely, consistent, and strategically aligned
Drive scientific communication planning across global and regional teams to ensure consistent, data-driven communication objectives across congress activities
Partner with Medical Communications to orchestrate Otsuka's scientific presence at congresses, including:
Abstract submissions and poster presentations
Oral presentations and late-breaking sessions
Sponsored symposia and educational sessions
Medical booth design and operations
Press activities and medica engagement
Develop and execute strategies for engaging external experts and stakeholders (e.g. (e.g. KOLs, Patient Advocacy Groups) before during and after congresses
Organize and facilitate investigator meetings and advisory boards in conjunction with congress
Coordinate opportunities for scientific exchange between Otsuka Medical Affairs personnel and external experts and stakeholders
Lead all aspects of congress planning activities and post-congress insight generation to maximize impact and inform future strategies
Implement innovative digital strategies to extend congress reach and engagement, including virtual and hybrid congress solutions
Establish KPIs for congress activities and implement systems to track and analyze performance
Conduct post-congress analysis toa assess impact and identify areas for improvement
Independent Medical Education (IME)
Develop and implement the global medical education strategy for the relevant therapeutic area in alignment with medical and objectives and strategy
Oversee the development of scientific exchange platforms, independent medical education (IME) initiatives to elevate disease and product knowledge globally
Partner with regional and local teams to ensure educational programs address unmet needs and comply with regional regulations and global standards
Identify, evaluate, and partner with external experts, medical societies and educational providers to ensure high-quality, unbiased scientific content delivery
Monitor educational impact through KPIs, metrics and insights
Cross-Functional Collaboration
Serve as the strategic lead and subject matter expert for the relevant therapeutical area medical education and congress activities
Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory, and Commercial teams to ensure scientific alignment and appropriate integration of new evidence into educational content
Provide leadership and mentorship to team members and vendors to ensure high standards of scientific integrity, external experts and stakeholder (e.g., KOL) experience and operational excellence
Create and manage congress budgets, ensuring cost-effectiveness and ROI and ensure compliant use of medical education and congress funding
Represent Global Medical Affairs in governance forums and cross-functional planning meetings
Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos and industry codes
Proactively identify and mitigate risks related to scientific exchange and external engagements xevrcyc based on Global Medical Affairs policies and SOPs
Consider technology and AI to support workflow improvement
Qualifications
Education and Experience:
Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) preferred
Additional business or communications training (MBA, MPH, etc.) preferred
12+ years of experience in Medical Affairs and ~5 years focused on experience leading global congress strategy, IME programs, or scientific engagement; experience in Nephrology, Immunology, or related therapeutic areas is preferred
Proven track record of successful congress planning and implementation on a global scale including implementation of digital and virtual congress solutions
Proven success managing matrixed & cross-functional global teams and external vendors
In-depth understanding of industry compliance, regulatory frameworks, and ethical considerations for scientific engagement
Skills and Competencies:
Strategic and analytical thinker with the ability to translate complex science for a variety of audiences and anticipate trends and shape proactive congress and educational strategies
Excellent project management, communication (written and verbal), and stakeholder engagement skills
Collaborative and communicative, with ability excel at building and maintaining relationships with external stakeholders and experts (e.g. KOLs, scientific)
Financial acumen and experience managing large program budget
Ability to influence across matrixed teams and drive strategic initiatives
Director of Marketing & Customer Analytics
Dallas, TX jobs
Reports to: Director of Planning & Analysis
Shop Avara is seeking a strategic and hands on-leader as our Director of Marketing and Customer Analytics to lead data-driven insights that fuel growth of our brand. This role will be the go-to partner for the Marketing and E-commerce teams - helping the organization deeply understand customer behavior, campaign performance, attribution, and lifetime value. You will blend analytical rigor with business understanding, turning complex data into actionable findings that can allow the marketing team to optimize acquisition, retention, and engagement. The ideal candidate thrives in a fast paced, entrepreneurial environment and is passionate about using data to unlock profitable customer growth and brand potential.
Key Responsibilities
Customer & Audience Insights
Lead deep understanding of who our current customer is - their motivations, preferences, purchase drivers, and behavioral patterns.
Own customer segmentation and profiling to identify high-value audiences and behavioral patterns.
Analyze customer acquisition, retention, repeat purchase, and churn dynamics across channels.
Build and maintain dashboards tracking customer KPIs (LTV, CAC, retention rate, frequency, AOV).
Partner with the Marketing and E-commerce teams to inform targeting, personalization, and lifecycle strategies.
Marketing Performance Analysis
Lead measurement and reporting of marketing campaign performance across paid, owned, and earned channels.
Build and refine marketing attribution models to assess ROI and inform budget allocation.
Identify drivers of traffic, conversion, and engagement to optimize channel strategy and creative direction.
E-commerce & Digital Analytics
Collaborate with the E-commerce team to monitor site performance, conversion funnel, and customer journey metrics.
Conduct deep-dive analyses on site behavior to identify conversion opportunities and UX improvements.
Partner on A/B testing strategy and post-campaign performance evaluations.
Data Infrastructure & Tooling
Work with Data Engineering partners to ensure data pipelines, tagging, and integrations are optimized for marketing measurement.
Define data requirements and metrics for new marketing channels, campaigns, and customer programs.
Implement and manage analytics tools and visualization platforms (e.g., GA4, Looker, Amplitude, or similar).
Cross-Functional Partnership
Work closely with FP&A to align marketing performance insights with financial outcomes (CAC, payback, contribution margin).
Collaborate cross functionally on insights that inform product development and brand storytelling.
Present findings and strategic recommendations to cross functional partners and leadership in a clear, compelling, and actionable way.
Project Manager (Utilities Construction)
Somerset, NJ jobs
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey.
In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle.
Additional Responsibilities
Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms.
Ensures the creation and distribution of weekly action item lists to project stakeholders.
Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms.
Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures.
Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process.
Review Contractor submittals, including monthly reports, schedules, and cash flow documents.
Manage the following:
facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties
the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections
the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications
the execution of the Quality Assurance and Control Plan
Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders.
Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan.
Support the documentation of all lessons learned activities in the Company database.
The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education.
Qualifications & Requirements
15+ years of professional experience.
Bachelor's degree in a technical field: engineering, project management, construction management.
Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT).
PMP Certification.
High level of computer expertise in multiple industry-wide software products, such as:
MS Office Products
Scheduling software such as Primavera and MS Project
Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR
PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems
Context, Environment, & Safety
A safety-minded individual who complies with the IPS Mission Zero Safety policy.
Capable of working alone or as part of a team without a significant level of supervision.
The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use.
Experience working in both a Home Office and a Field environment.
Travel to client sites as needed.
This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Project Manager - Enterprise
Houston, TX jobs
The Project Manager Operations is responsible for managing projects as assigned, including leading and coordinating, having the ability to work independently or with minimal supervision within one or multiple departments and locations, and completing projects related to strategic, financial, and market development activities and initiatives. Ensures projects are completed on time and within scope and budget by defining and managing project goals, scope, timeline, and resources and mitigating risks and issues throughout the project lifecycle. S/he is responsible for project communication and managing numerous internal and external stakeholders, including vendors. S/he regularly provides and disseminates project analysis, assignments, timelines, and progress reports to various levels of leadership, as appropriate.
Salary Range: $85,076 - $105,094 (Pay is based on several factors including but not limited to education, work experience, certifications, etc.)
Qualifications:
EducationA.Bachelor's degree or equivalent experience (equivalent experience includes 4 years in a project management-related role in addition to the below experience requirements.
PreferredMBA, MHA, MPH, or related advanced degree
Experience
Minimum 3 years experience in project management roles with at minimum 1 years experience directly managing/leading highly complex projects involving multiple teams OR current KSC Administrative Fellow experience (Fellowship program must be completed to qualify for the role)
OR
Minimum 5 years experience in project management roles with at minimum 3 years experience directly managing/leading projects involving multiple teams - Demonstrated track record of delivering projects with significant positive financial impact - Experience in healthcare data analytics
License - PMP Certification Preferred.
Special Skills
Strong working knowledge of healthcare/clinical operations - Ability to conduct effective presentations - Strong understanding of project management tools, methodologies, project metrics and KPIs.
Experience supporting project assessments, root cause analysis, and deep dives on problem projects to get them back on track.
Demonstrated a history of excellent facilitation and influence skills, working with internal and external stakeholders at all levels.
Experience working with complex projects where deadlines and scope shift frequently; demonstrated ability to be flexible and adaptable to change - Advanced spreadsheet skills (i.e. creating pivot tables, performing v-lookups, and managing large data sets)
Demonstrated ability to organize large-scale cross-functional projects and teams effectively - Maintains a safe environment where everyone feels respected, empowered, and free to express their constructive thoughts and feelings - Fosters an environment of creativity and innovation, focusing on the empowerment and support of staff through tools and continuous process improvement.
Able to influence results without direct authority in a matrixed environment with internal and external stakeholders, including vendors.- Excellent communication (verbal and written) and critical thinking skills - Exceptional organizational and planning skills with attention to detail - Strong business acumen and technical acumen.
Proficient in MS Office Suite including Project, Excel, Visio, PowerPoint, and SharePoint. Ability to successfully manage multiple priorities with competing priorities. Ability to effectively communicate with patients, physicians, family members, and co-workers in a manner consistent with a customer service focus and application of positive language principles.
Mobility Client Project Manager
Newark, NJ jobs
NOT A C2C OPPORTUNITY 35 HOURS A WEEK
Travel Requirement: 25% travel to various locations in North America for internal collaboration or onsite for project execution.
During large scale projects, the percentage could fluctuate.
Adherence to corporate travel and entertainment policy is required.
Mobility Client Project Manager (PNA) #1044678
Job Description:
We emphasize continuous learning through project reviews, which helps team members build leadership skills and operational expertise.
While this role starts as a contract position, it's part of a growing team with opportunities for long-term engagement and advancement as we expand our PM capabilities.
If you're looking for a role where you can make a measurable difference and grow professionally, this is the right place.
Basic Qualifications - Scope:
Reports to Senior Project Manager, Mobility
Manages project budgets, resources, and cross-functional teams
Education & Experience:
University degree in business or related field preferred
5 years or more of direct experience in Project Management, Program Management, or similar experience
Project Management Professional (PMP) or Certified associate in project management (CAPM) or a related PMI Certification preferred
Competencies:
Strategic Agility: Adapts project strategies to evolving client and business needs, balancing structure with flexibility.
Communication & Influence: Communicates effectively across all levels, translating complex information into actionable insights.
Process Discipline: Applies structured methodologies and tools for consistency and continuous improvement.
Cross-Functional Collaboration: Builds strong partnerships across departments and with clients.
Analytical Thinking: Uses data-driven insights for decision-making and risk assessment.
Change Leadership: Guides teams through transformation initiatives, promoting innovation and learning.
Customer-Centric Mindset: Prioritizes client needs and business value in project outcomes.
Other Requirements:
Travel Requirement: 25% travel to various locations in North America for internal collaboration or onsite for project execution.
During large scale projects, the percentage could fluctuate.
Adherence to corporate travel and entertainment policy is required.
Key Accountabilities:
40% - Project Management
Lead client projects using established project management best practices and internal processes to fit client needs within the scope of hardware and services sold.
Facilitate collaborative planning sessions to define scope, objectives, deliverables, success metrics, risks, milestones, schedules, and resource requirements.
Schedule and lead project meetings, ensuring alignment on timelines and deliverables.
Monitor and report on project milestones, proactively addressing risks and potential delays.
Conduct postmortem reviews to identify improvement opportunities.
Communications Management
Establish and maintain consistent communication with clients, business partners and internal stakeholders regarding deliverables, timelines, risks, and progress.
Define and reinforce clear expectations throughout the project lifecycle.
Proactively resolve issues, escalating to leadership as needed.
Deliver weekly project summary updates to PMO leadership, project stakeholders and client teams.
30% - Process Management
Maintain comprehensive documentation of all project artifacts, ensuring accuracy and version control.
Archive project documentation upon completion for traceability and compliance.
Enforce standardized reporting and monitoring procedures, aligning with PMO governance.
Maintain up-to-date project records in PMO tracking systems (e.g., Smartsheet, Power BI, SharePoint, etc.) ensuring visibility into project status, dependencies, and performance metrics.
30% - Support the PMO in managing a portfolio of internal and customer-facing initiatives by contributing to the continuous improvement of project execution processes.
Additional Information:
At FastTek Global, Our Purpose is Our People and Our Planet. We come to work each day and are reminded we are
helping people find their success stories
. Also,
Doing the right thing
is our mantra. We act responsibly, give back to the communities we serve and have a little fun along the way.
We have been doing this with pride, dedication and plain, old-fashioned hard work for 24 years!
FastTek Global is a financially strong, privately held company that is 100% consultant and client focused, operating in nearly half of the states in the U.S., Europe and India.
We've differentiated ourselves by being fast, flexible, creative and honest. Throw out everything you've heard, seen, or felt about every other IT Consulting company. We do unique things and we do them for Fortune 10, Fortune 500, and technology start-up companies.
Our benefits are second to none and thanks to our flexible benefit options you can choose the benefits you need or want, options include:
Medical and Dental (FastTek pays majority of the medical program)
Vision
Personal Time Off (PTO) Program
Long Term Disability (100% paid)
Life Insurance (100% paid)
401(k) with immediate vesting and 3% (of salary) dollar-for-dollar match
Plus, we have a lucrative employee referral program and an employee recognition culture.
FastTek Global was named one of the Top Work Places in Michigan by the Detroit Free Press in 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, and 2023!
To view all of our open positions go to: *******************************************
Follow us on Twitter: *********************************
Follow us on Instagram: ***************************************
Find us on LinkedIn: ****************************************
You can become a fan of FastTek on Facebook: ***************************************
AI & Hiring Disclosure
We use AI tools to support parts of our hiring process, such as reviewing applications and identifying potential matches. These tools are designed to promote efficiency, consistency, and fairness, and they are always used under human oversight.
All personal data collected is used solely for recruitment purposes, and you have the right to know, access, or request deletion of your data at any time, subject to legal limits.
If AI will be used in a video interview, you'll be informed in advance and asked for your consent, with the option to opt out.
Our tools are regularly reviewed to detect potential bias and to ensure compliance with all applicable laws and our commitment to inclusive hiring.
To learn more or exercise your rights, please contact us at ****************.
Senior Manager, Reimbursement Access - West
Remote
The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers.
Responsibilities
Team Leadership & Talent Development
Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies.
Provide coaching, mentorship, and performance management to drive effectiveness and professional growth.
Lead field-based access teams to execute patient support strategies that improve access and affordability for patients.
Reimbursement Strategy & Execution
Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals.
Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients.
Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives.
Operational Excellence
Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function.
Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance.
Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership.
Stakeholder Engagement
Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed.
Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives.
Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed.
Qualifications
Bachelor's degree in business, healthcare, or related field (advanced degree preferred).
Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles.
Prior leadership experience managing field reimbursement teams strongly preferred.
In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services.
Experience in rare diseases or specialty biologics/therapies.
Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment.
Willingness to travel (up to 30%) to support field teams and stakeholders.
Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism
A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position.
Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-REMOTE
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 $130,000 to $220,000. 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.
Auto-ApplySenior Manager, Patient Access - Endocrinology (Rare Disease)
Remote
The Senior Manager, Patient Access is responsible for managing the operational plans for all patient services tactics to support the Xeris product portfolio. This leadership role is responsible for assigned Xeris patient support responsibilities inclusive of reimbursement, financial, patient assistance, patient advocacy management and adherence support. The incumbent will manage daily operations of a team of field-based Patient Access Managers across geographically aligned regions.
Responsibilities
Manage patient services programs for Xeris products.
Collaborate cross functionally to ensure successful implementation and long-term success of Patient Services' strategy and operations by understanding patient journey and best in class services required for excellence across reimbursement, financial support, patient advocacy and adherence.
Embrace continuous improvement initiatives and innovative program enhancements throughout the program lifecycle.
Proactively cultivate collaborative and productive relationships with a wide range of teams, including Marketing, Sales, Market Access, Legal, and Compliance to discuss service design and develop action plans for execution, in a constantly changing environment.
Drive project management and execution for cross-functional Patient Services Projects.
Act as a consistent liaison, point of contact and facilitator to enable appropriate discussions and projects between Patient Services, Brands, Training, IT, Commercial Operations, and other business partners and departments related to Patient Services' operational activities.
Develop Patient Services CRM expertise; coordinate with IT and train internal and external end users.
Serve as the Patient Services Lead in working with IT on the development of patient services systems, system upgrades, and reporting platform.
Collaborate with Operations to monitor operational metrics and routinely monitor to identify changes in patterns.
Coordinate with all applicable stakeholders, implement improvements and share best practices within patient services and across business units.
Oversight and management of team performance to meet defined objectives. Provide strong people management to attract, coach and retain team of impactful and engaged Patient Access Managers.
Create an environment of continuous learning where team members feel challenged and engaged.
Foster team effectiveness within matrix team by sharing knowledge, experience, and information.
Establish and/or further develop and continuously strengthen advocacy relationships with national and community organizations through compliant and thoughtful engagement in alignment with company business priorities and objectives.
Identify opportunities for patients and patient advocates to participate in development of educational materials, review clinical study protocols and other documents and programs (e.g., informed consent, patient, and product services, etc.)
Establish and help operationalize best practices for communicating with patients who reach out to Xeris proactively via phone, email, etc. in collaboration with personnel responsible for medical information.
Communicate key learnings from the patient community to inform cross-functional (i.e. medical, clinical, and commercial) team strategies.
Qualifications
Bachelor's Degree in business administration, management, marketing, or equivalent experience preferred.
A minimum of 7 years of experience in the pharmaceutical/healthcare environment, in roles involving patient advocacy, reimbursement, and marketing/sales, including previous patient access management experience.
Ability to exhibit agility in an evolving environment.
Decision support experience.
Demonstrated knowledge of and ability to comply with HIPAA guidelines.
Strong track record of driving results in a complex internal and external environment
A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position.
Competencies: Project Management, Relationship Management, Collaborative Team Leadership, Change Agility, Authentic Leadership, Talent Developer, Attention to Details, Presentation skills, Written and Verbal Communication skills
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a remote position and requires travel up to 25%.
The level of the position will be determined based on the selected candidate's qualifications and experience.
#LI-REMOTE
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 $180,000 to $200,000. 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 bonus 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.
Auto-ApplySenior Manager, Reimbursement Access - West
Chicago, IL jobs
The Senior Manager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers.
**Responsibilities**
+ **Team Leadership & Talent Development**
+ Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies.
+ Provide coaching, mentorship, and performance management to drive effectiveness and professional growth.
+ Lead field-based access teams to execute patient support strategies that improve access and affordability for patients.
+ **Reimbursement Strategy & Execution**
+ Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals.
+ Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients.
+ Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives.
+ **Operational Excellence**
+ Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function.
+ Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance.
+ Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership.
+ **Stakeholder Engagement**
+ Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed.
+ Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives.
+ Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed.
**Qualifications**
+ Bachelor's degree in business, healthcare, or related field (advanced degree preferred).
+ Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles.
+ Prior leadership experience managing field reimbursement teams strongly preferred.
+ In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services.
+ Experience in rare diseases or specialty biologics/therapies.
+ Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment.
+ Willingness to travel (up to 30%) to support field teams and stakeholders.
+ Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism
+ A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position.
+ Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
+ Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_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 $130,000 to $220,000. 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._
**Job Locations** _US_
**Title** _Senior Manager, Reimbursement Access - West_
**ID** _2025-2168_
**Category** _Market Access_
**Type** _Full-Time_
Senior Manager, CMC Global Regulatory Affairs
Montgomery, AL jobs
The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. This position requires approximately 20% domestic/international travel.
****
+ Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA/MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements.
+ Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters.
+ Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy).
+ Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products.
+ Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes.
+ Support departmental initiatives such as preparing/updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
+ Experience in CPP application filing through eCATS, 510(j)(3) reporting through next Gen portals is a plus.
+ Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
+ Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools.
+ Performs other duties as assigned related to CMC RA function.
**Qualifications**
**Education** :
+ BS/MS/PhD in Chemistry, Pharmacy, or related scientific discipline.
+ RAC certification will be a plus.
**Experience** :
+ 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide or oligonucleotide products.
+ Proven track record in late-stage development investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead.
+ Regulatory experience in handling-controlled substance applications will be a plus.
**Skills:**
+ Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical/quality control, GMP and related issues.
+ Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application and post-approval.
+ Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada.
+ Comprehensive understanding of the global regulatory environment.
+ Strong analytical, problem solving, organizational and negotiation skills. Strong ability to work in a matrix environment and across cultural lines.
+ Strong leadership, communication, and negotiation skills.
+ Ability to manage complex projects and timelines across multiple regions.
+ Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ CMC reviewer (assessor) with FDA or EMA will be a plus.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Manager, Global Regulatory Affairs
Montgomery, AL jobs
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Manager, Global Regulatory Affairs
Sacramento, CA jobs
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Business Unit Director
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Objective:**
Develop the customer relationship through Customer Focused teams of dedicated employees to provide an 'industry leading customer experience'. Develop specific customer strategies with the Account Executive and monitor attainment of projects and goals. Provide leadership and direction to the teams to ensure the groups are performing within prescribed timelines and budget. Collaborate with other BUD's and internal departments to ensure the use of best practices within appropriate guidelines.
**Essential Duties & Responsibilities:**
+ Interact with other business units and functional departments to define production plans, yearly goals and budgets.
+ Establish business unit and individual goals and objectives in alignment with site goals and customer requirements.
+ Primary customer contact for business and relationship issues.
+ Manage short-term and long-term customer forecasts.
+ Quarterly customer meetings/business reviews: accountable for meeting, success, develop agenda, coordinate meeting details with customer and PCI internal staff, lead the organization in detail preparation, lead meetings, insure professional follow-up on all open items
+ Oversee business and quality issues.
+ Manage customer visits to PCI.
+ Adherence to PCI and cGMP policies, procedures, rules and regulations.
+ Attendance to work is an essential function of this job.
+ Other duties as assigned by Supervisor/Manager.
**Core Attributes:**
+ Act as a positive role model that accomplishes and supports management objectives and diversity.
+ Assists in diffusing conflicting situations. Communicates clear directions and holds employees accountable.
+ Celebrates and rewards significant achievements of others.
+ Builds trusting coaching relationships.
+ Helps people assess their skills and identify development objectives.
+ Ensure annual performance reviews are written for each employee within reporting structure. Complete and submit documentation, as necessary, for any required human resource actions.
**Supervisory Responsibilities:**
+ Supervise approximately two or more associates within the Project Management function.
+ Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
+ Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
**Qualifications:**
This position requires a history of project accomplishments and demonstrated leadership excellence preferably as a project manager at PCI. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Minimum four years' experience in the pharmaceutical and/or packaging industry or a related field, with a history of project accomplishment and leadership excellence in the project management arena. Preferred packaging and/or pharmaceutical experience.
+ Bachelor's or Master's degree from four-year college or university; Packaging Science degree preferred.
+ Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
+ Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
+ Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
+ Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
+ Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
**\#LI-JM1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled