Senior Project Manager

Mar 27, 2023

Senior Project Manager

US Remote-Based / Eastern Time Zone

Overview

Lead a team of project management staff tasked with managing the flow of products to global clinical trial locations as well as manage operations of the team based on approved timelines.

Responsibilities

Effectively manage all functional responsibilities of dedicated project management team.
Support Portfolio Director and provide client facing interface as may be required.
Ensure all timelines are satisfactorily met and supply is readily available for on-demand shipments.
Partner with project management team to confirm understanding of the project scope and agreed upon timelines, budgets and customer requirements.
Ensure proper tracking of project budgets assigned.
Confirm team understanding and abilities to successfully implement and manage all project changes for seamless customer fulfillment as required.
Lead, supervise, coach, mentor, train and evaluate performance of team members assigned to the projects, identifying performance gaps and recommending development opportunities as may be required.
As a senior point of contact in support of project management, act as liaison between sponsor and internal teams as may be required.
Actively participate, and at times, lead team meetings.
Drive, participate and contribute positively to process improvement initiatives and creation of SOPs and functional training
development/revision and implementation.
Analyze protocol provided by the sponsor, forecast demand and develop a supply plan based on enrollment sites and other factors.
Escalate to the Portfolio Director a weekly status report for all team projects.
Work on and or lead projects as may be required.
Ability and desire to work a project to completion meeting and or exceeding timeline deliverables.
Apply Good Manufacturing Principles (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP) and other relevant GXP in all areas of responsibility
Demonstrate and drive the Ancillare mission, values and strategy.
Travel as may be required.
Perform other duties as assigned.

Qualifications

Bachelor degree or equivalent required, may consider equivalent relevant industry experience, PMP preferred.
5+ years of successful project management experience, preferably in a clinical environment required.
Experience in drug and ancillary supply management and clinical trial forecasting desired.
Previous supervisory experience required.

Requirements

Ability to effectively communicate in English both written and verbal.
Proficient presentation skills.
Must be detail oriented and organized with strong analytical and problem solving skills.
Ability to successfully delegate assignments as required and evaluate performance, identifying gaps and providing coaching as needed.
Highly organized with the ability to meet changing demands.
Sound computer skills, proficient in Microsoft office preferred.
Demonstrated ability to effectively support client relations with existing and new business opportunities.
Ability to multi task and successfully manage multiple projects simultaneously.
Ability to influence and gain collaboration across all levels of the organization.
Rigor to strictly adhere to company SOPs and regulatory compliance.

I'm Interested

Associate Director, Business Development

Mar 23, 2023

Associate Director, Business Development

US Remote-Based / Eastern Time Zone

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Overview

The Associate Director Business Development is responsible for obtaining and growing new business development opportunities, while further helping to establish and promote the Company’s mission, vision, and culture. Build business relationships, and marketing plans, drive revenues, attend to client requests and proposals, and ensure all client deliverables are successfully met on time.

Responsibilities

Identify relevant target prospect clients and contacts; able to execute effective account exploration and mining tactics.
Communicate effectively with a variety of decision makers and influencers. Identify and classify the sales potential of each client. Apply discovery abilities including prospecting, profiling, qualifying, identifying client needs, and presenting solutions.
Establish and maintain business contacts and relationships within designated client companies.
Successfully build a network of new potential clients to drive new business opportunities and grow pipeline of business.
Uncover new sources of revenue and promote company deliverables. Increase brand awareness by educating prospects on the scope and depth of our solutions while clearly differentiating Ancillare from competitive offerings as the global leader in clinical and ancillary supply chain management.
Research and remain current on competitor tactics, market conditions and trends in the industry.
Ensure overall client satisfaction and consistent quality of excellence and service.
Manage the sales process from initial contact to RFI/RFP completion to implementation and transition plans.
Obtain, prepare, and present new business proposals.
Promote Ancillare’s capabilities, quality, and specialization services; Successfully conduct Ancillare’s capabilities presentation/s.
Manage client relationships to ensure that all needs are satisfactorily met and that fully outsourced, long-lasting engagements are created with Sponsor companies.
Collaborate with clients to obtain project or program specifications, timelines and requirements and communicate awards, new business, timelines, and other requirements to other departments/internal counterparts to ensure success of each project/program.
Understand CRM and system needs, the data required, to strategically vet RFP requests and ensure key variables are available at opportunity qualification.
Develop and implement plans to successfully meet/exceed client requirements and specifications.
Maintain positive, open communication with clients, providing regular updates to clients for ongoing programs/projects, act as liaison between clients and Ancillare.
Regularly report business development activity to Executive Leadership and colleagues.
Periodically assess and report territory plan, pipeline activity and forecast sales goals for quarterly and year-end reports.
Manage and track all business development efforts and activities in company systems.
Ensuring, in coordination with the Proposal’s Team, the accurateness of the Company’s proposal to our clients’ needs, inclusive of regulatory and legal compliance.
Ensuring, in coordination with Project Management, Medical, Procurement, Logistics and other departments (as necessary) a solid understanding of the operative aspects of the program/project as required by the client.
Communicate with VP, Global Business Development for decisions on the appropriate attendance of Company representatives at client meeting.
Attend trade shows and other marketing events to promote Ancillare.
Ability and desire to work a project to completion meeting and or exceeding timeline deliverables.
Demonstrate and drive the Ancillare mission, values and strategy.
Participate and contribute positively to process improvement initiatives.
Travel domestically and internationally as may be required.
Perform other duties as assigned.

Qualifications

Bachelor’s degree in Business, Marketing, Life Sciences preferred. May consider equivalent work experience.
3+ years of experience selling Clinical Research, Pharmaceutical or related Industry Services REQUIRED.
5 +years professional experience, with a proven track record, working in a business development and/or operational delivery role.
Extensive contacts within the pharma/biotech/clinical supply industry.
Experience working in a startup organization highly desirable.

Requirements

Ability to effectively communicate in English both written and verbal.
Ability to partner and successfully gain collaboration across all levels of the organization.
Superior business development operations practical knowledge.
Active listening and exceptional communication skills both oral and written with an ability to positively influence logically and confidently communicate.
Ability to communicate on a one-to-one basis and before groups to obtain or provide information.
Ability to work in a fast-paced environment, under pressure of time and conflicting demands meeting demands while maintaining a professional demeanor.
Must have a demonstrated ability of understanding clinical trials.
High level of ownership, energy, hands on approach and personal drive.
Strong analytical skills and excellent independent decision making and creative problem-solving skills.
Rigor to adhere to SOPs and regulatory compliances.
Demonstrated effective Project Management skills.
Ability to effectively use Microsoft Office Suite to capture and present information.
Ability to develop, organize, and manage multiple tasks.
Ability to travel domestically & internationally up to 50% of the time, as needed.

I'm Interested

Quality Assurance Specialist

Mar 20, 2023

Quality Assurance Specialist

Horsham, PA

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Overview

The Quality Assurance Specialist provides advanced quality assurance support, ensuring services, processes, facilities, investigations, Internal\Supplier audits and or systems are in compliance with Ancillare’s quality program. Under the direction of the Director Quality Assurance this role is responsible for monitoring, inspecting, and proposing measures to correct and improve Ancillare’s Quality Management Program.

Responsibilities

Provides guidance and quality assurance support, ensuring services, process, facilities, reporting, investigations, audits and or systems are in compliance with quality consulting with QA Management to resolve complex quality issues in a timely and effective manner.
Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Conduct and or direct risk-based quality event (e.g., deviation, complaint, nonconformance) investigations and determine/implement corrective actions to correct immediate issue and prevent recurrence.
Provide Ancillare team members with guidance to writing an investigation, providing support for team to perform data analysis to identify systemic root causes and Corrective and Preventive Actions that result in quality improvements.
Maintains a familiarity with Ancillare’s systems and related processes, Ancillare’s Standard Operating Procedures and relevant regulations and guidelines.
Handles Supplier Qualification and Requalification process including external supplier audits and requalification procedures.
Conduct and report on initial supplier audits for the setup of a Depots.
Develop and maintain metrics pertaining to supplier performance.
Develop & deploy the Internal Audit program, working actively with all departments in ensuring Quality Assurance; support audits and report preparation/distribution, Support quality issues management, Corrective and Preventative Action (CAPA) development.
Seeks out advice on complex quality decisions from Manager/ Director QA
Attending (or where required, lead) internal quality-focused meetings.
Under the direction of the QA Manager act as backup for ZEN issues and Quality Issues (including customer communication).
Ability and desire to work a project to completion meeting and or exceeding timeline deliverables.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Contribute to development of SOPs and best practices supporting Ancillare’s quality focus.
Demonstrate and drive the Ancillare mission, values and strategy.
Drive, participate and contribute positively to process improvement initiatives and creation of SOPs and functional training development/revision and implementation.
Enhance organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to the job.
Work outside usual hours as may be required to support global business.
Travel as may be required.
Perform other duties as assigned.

Qualifications

3+ years of experience working in a Quality Assurance /Control role.
Bachelor’s degree preferred may consider equivalent quality work experience.
Operative knowledge of MS Office (including SharePoint) computer skills.
Proficient in Oral & Written communication skills.
Demonstrates a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques.

Requirements

Ability to receive, comprehend and to effectively communicate in English detailed information through verbal and written communication.
Ability to partner and successfully gain collaboration across all levels of the organization.
Detail oriented, highly organized flexible thinker with strong analytical and problem-solving skills with an ability to quickly adapt to a rapidly changing environment.
IT literate, proficient in the use of lap-top computer and software systems including Microsoft Office.
Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning.
Ability to effectively work both strategically and tactically, independently as well as in a team effort.

I'm Interested

Supply Chain Specialist

Mar 15, 2023

Supply Chain Specialist

US Remote-Based / Eastern Time Zone

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Overview

Collaborating with other shared services the Supply Chain Specialist will work to increase company revenue through supply chain management in areas of sourcing, procurement, logistics and partnered with distribution provide more reliable service for our clients.

Responsibilities

In a team environment work effectively to execute the reverse logistics flow of products from global clinical trial locations per approved timelines.
In collaboration with the logistics team provide support to logistics projects ensuring timelines are met, budgets are contained, and regulations are followed.
Support and develop joint objectives with intersecting groups to ensure alignment with logistics global partners for the assurance of supply in all markets to customers.
Provide CPG Team with logistics supply plan analysis.
Monitor and measure freight costs. Work with Procurement to manage carrier relations and negotiate contracts.
Update ANSUMS/ERP system as appropriate and required.
Prepare invoices, reports and other documents including department metrics as assigned.
Perform routine duties such as organizing and maintaining paper and electronic files, working with Excel spreadsheets, MS Office, and other Company systems as needed providing reports and analytics routinely and as needed.
Interface directly with management, quality assurance and logistics teams as applicable for reclamation activities.
Ensure that all processes are implemented and completed according to all relevant SOPs, quality assurance and logistics requirements, and company strategic direction.
Provide operational support to ensure maximum productivity while reinforcing trade compliance.
Ability and desire to work a project to completion meeting and or exceeding timeline deliverables.
Demonstrate and drive the Ancillare mission, values and strategy.
Enhance the department and organization by accepting ownership for accomplishing new and different opportunities in the spirit of continuous improvement.
Maintain familiarity and compliance with all relevant company policies and procedures.
Participate and contribute positively to process improvement initiatives.
Travel as may be required.
Perform other duties as assigned.

Qualifications

BA/BS degree preferred, will consider equivalent relevant work experience.
Prior project management experience preferred.
Prior working experience in a pharmaceutical industry, ancillary supply or supply chain is highly desirable and preferred.

Requirements

Ability to effectively communicate in English both written and verbal.
Must be detail oriented and organized with strong analytical and problem-solving skills.
Ability to effectively work with tight deadlines.
Proficient in Microsoft Excel, PowerPoint, Word and project software.
Demonstrated high degree of flexibility and adaptability to deal with ambiguous and dynamic situations.
Collaborative mindset and aptitude to embrace change.
Ability and desire to effectively work with and collaborate with employees at all levels of the organization.
Ability to effectively work individually or in a team with minimal supervision.

I'm Interested

Procurement Manager

Mar 15, 2023

Procurement Manager

US Remote-Based / Eastern Time Zone

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Overview

We are seeking a Procurement Manager to join our team to manage the sourcing of clinical and ancillary supplies for worldwide clinical trials for global pharmaceutical and biotechnology companies, as well as medical and contract research organizations. This role will provide analysis including strategic analysis and insight into suppliers and markets, prepare clinical supply plans in support of new and revised study opportunities, participate in negotiation strategies, conduct RFPs, RFQs and quotation analysis, cost modeling and supplier management, and oversee PO execution and required ERP activity.

Responsibilities

Create and execute RFPs and RFQs. Build supply plans together with subsequent structured information analysis and business requirements.
Conduct detailed supplier and supply market analysis looking at facts, trends, and data analysis. Execute continuous learning and product awareness programs for procurement and project management colleagues. Steward a repository of specification templates to assist in defining supply requirements.
Ensure that appropriate supplier agreements and relationships have appropriate KPI’s and metrics to achieve a win-win relationship. Monitor, report, manage and continuously improve supplier performance. Ensure that supplier qualification criteria are being met. Coordinate Return Good Authorization activity.
Ensure that the appropriate contingency and remediation plans are in place for supply plans. Categorize the ancillary supply as high/medium/low risk per established guidelines.
Be an active member on one or more sourcing teams utilizing the above essential functions in a spirit of continuous improvement to drive assurance and quality of supply, service, cost and innovation.
Manage, capture and report savings per the Ancillare global procurement savings handbook and customer requirements.
Work with procurement specialists to ensure the company funds are expended for clinical supplies in compliance with the corporate grant of authority table and in conjunction with approved supply plans.
Ensure customer satisfaction by developing strong collaboration and trust with internal stakeholders, customers and suppliers.
Enhance the department and organization by accepting ownership for accomplishing new and different opportunities in the spirit of continuous improvement.
Maintain familiarity and compliance with all relevant company policies and procedures.
Other duties as may be assigned.

Qualifications

Three to five years of procurement experience in lab supplies and/or clinical supplies required.
Bachelor’s degree required or equivalent work experience.

Requirements

Ability to effectively read, write, speak, and understand English.
Must be detail oriented and organized.
Ability to effectively work with tight deadlines.
Proficient in Microsoft Excel, PowerPoint, Word and project software.
Demonstrated high degree of flexibility and adaptability to deal with ambiguous and dynamic situations.
Demonstrated working knowledge of total sourcing spectrum from need identification to contract execution, including stakeholder and supplier management.
Collaborative mindset and aptitude to embrace change.
Ability and desire to effectively work with and collaborate with employees at all levels of the organization.

I'm Interested