Alpha Consulting Corp Jobs (5)

PHARMACEUTICAL LABELING SPECIALIST

TAMPA, FL

100% REMOTE Position

2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.

Pay ranges between $48.40 - $51.47 per hour.

Required Skills :

• Bachelor's degree - or Master's Degree, preferred in sciences with 2 years of direct Labeling Experience in a Regulated environment, or 3 years with a combination of Labeling Experience and Pharmaceutical experience.
• Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU.
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail / Calendar; willing to learn additional applications as needed.
• Experience working on multi-disciplinary teams and projects.
• Good knowledge of rigorous pharmaceutical and / or scientific documentation practices and change control processes (e.

g., revision control).

• US military experience will be considered towards industry experience requirements.
• Good communication and organizational skills and a meticulous eye for detail.
• Good understanding of pharmaceutical or medical terminology.
• The ability to work as part of a team that supports global functions with a high level of professionalism.
• Knowledge / understanding of another language in a region supported (e.g., Spanish, Arabic, Chinese).

Project Description :

• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists.
• Manages external requests for country specific labeling information (e.g., medical content, pharmaceutical properties) from various sources or reference documents.
• Notifies appropriate groups or changes or recent source / reference labeling approvals.
• Prepares country-specific labeling in support of safe and appropriate use of the Client products for in-scope countries;

maintains country specific translation master copy to meet labeling responsibilities.

• Prepares, tracks, maintains and reviews required labeling documents (e.g., physician's label, patient insert, carton, label, blister, tenders) using Text verification Tools, and additional software or process tools to maintain change history for all labeling documents.
• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
• Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren : [email protected]

ALPHA'S REQUIREMENT #23-01191

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

LI-LG1

LI-Remote

PHARMACEUTICAL LABELING SPECIALIST

TAMPA, FL

100% REMOTE Position

2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.

Pay ranges between $48.40 - $51.47 per hour.

Required Skills :

• Bachelor's degree - or Master's Degree, preferred in sciences with 2 years of direct Labeling Experience in a Regulated environment, or 3 years with a combination of Labeling Experience and Pharmaceutical experience.
• Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU.
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail / Calendar; willing to learn additional applications as needed.
• Experience working on multi-disciplinary teams and projects.
• Good knowledge of rigorous pharmaceutical and / or scientific documentation practices and change control processes (e.

G., revision control).

• US military experience will be considered towards industry experience requirements.
• Good communication and organizational skills and a meticulous eye for detail.
• Good understanding of pharmaceutical or medical terminology.
• The ability to work as part of a team that supports global functions with a high level of professionalism.
• Knowledge / understanding of another language in a region supported (e.G., Spanish, Arabic, Chinese).

Project Description :

• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists.
• Manages external requests for country specific labeling information (e.G., medical content, pharmaceutical properties) from various sources or reference documents.
• Notifies appropriate groups or changes or recent source / reference labeling approvals.
• Prepares country-specific labeling in support of safe and appropriate use of the Client products for in-scope countries;

maintains country specific translation master copy to meet labeling responsibilities.

• Prepares, tracks, maintains and reviews required labeling documents (e.G., physician's label, patient insert, carton, label, blister, tenders) using Text verification Tools, and additional software or process tools to maintain change history for all labeling documents.
• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
• Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren : [email protected]

ALPHA'S REQUIREMENT #23-01191

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

LI-LG1

LI-Remote

PROJECT MANAGER FOR PHARMACEUTICAL

JERSEY CITY, NJ

This is a Remote role!

Pay ranges between $65.50 - $70.92 an hour!

Required Skills :

• Bachelor's degree + minimum 3 years of relevant experience in life sciences and process and systems related coordination.
• Project management experience.
• Experience within Veeva MI system is a plus.
• Experience in partnering with Business stakeholders across geographies and functions to inform global process design and execution.
• Expertise in executing process and systems workshops, meetings, and other methodologies to inform effective and efficient, new and updated processes and systems.
• Attention to detail, excellent communication skills and the ability to work independently, escalating risks and issues as appropriate.
• Demonstrated success in a fast-paced environment, with the ability to learn on the fly while understanding and solving new problems, requiring a high level of independent judgement and initiative.
• Ability to identify the most efficient and effective way to implement new services.
• Proven ability for innovation and non-traditional thinking.
• Strong judgement on ideas that can really lead to compliant and value adding customer solutions.
• Excellent verbal and written technical and non-technical communication.
• Outstanding facilitation skills.
• Good interpersonal and networking skills.
• Friendly, outgoing, energetic, enthusiastic, stimulating.
• Curious and constantly challenging the status quo.
• Demonstrated ability to collaborate cross-functionally and with stakeholders.
• Strong interpersonal and time management skills.
• Expert level in MS Office package, including MS Teams.
• Having worked at affiliate, regional and / or global level.
• Change management, Sigma and / or Project Management certification.

Project Description :

Medical Services Project Manager role will report to the Medical Affairs Director and will focus on coordinating projects, data and systems in support of Global Medical Affairs Capability GMAC.

• They will participate in designated point of contact (DPOC) and health information services transformational initiatives in the fast-paced and dynamic environment of GMAC.
• System Administration :
• Partnering with internal or external partners for DPOC MI system initiation, configurations which enable GMAC business process.
• Schedule business process alignment and requirement gathering workshops.
• Participating in Business / System requirements for development as well as User Acceptance Testing and Communications to stakeholders regarding system updates / upgrades.
• Draft, review and obtain approval of business requirements / user stories for Veeva MI and associated integrations.
• System Support & Process Execution :
• Accountable for systems governance such as license provisioning process and access management.
• Support system end users during hyper care period for system establishment.
• Support systems and process training roll out across the globe.
• Support SOPs reformulation, communication, and approval process. Assist in the development of training materials.
• Through these responsibilities, this role will identify opportunities for additional process improvements, innovations and system functionality enhancements / upgrades.
• Based on capacity, this role will also have the opportunity to work on other core projects within GMAC.
• Successfully partner within GMAC and across business functions and geographies to make effective decisions, solving complex problems with efficient solutions and escalating risks and issues as appropriate.
• Support for Help Desk escalations around system functionality and user roles.
• Collaborates with key stakeholders within GMAC and other internal business partners to design, develop and utilize metrics for quality and efficiency assessment and continuous improvement recommendations.
• Administrate cross-divisional governance meetings (as needed) to support meetings objectives, alignment across system users for configuration changes and release management.
• Facilitates program training and maintenance of program-related reference guides and / or training documents on both the process and the applicable system.
• Adhere to the compliance and regulatory procedures, working closely with Global Compliance and Legal.
• Responds and complies with any program investigations, audits, or assessments working closely with DPOC Director on the control plan and any audits of the process.
• Understands the business process and objectives to enable configuration decisions.
• Engages cross-functionally across the organization to develop test and implementation plans, drive results and resolve issues, using an ability to assess and course correct when necessary.
• Ability to multi-task and serve the Process & System Coordination for multiple processes and systems leveraged by GMAC.
• Implement processes utilizing improvement methodologies such as Six Sigma and / or Lean.
• Ensure efforts and priorities align to overall GMAC Strategic Initiatives while focusing on efficient, effective process execution.
• Track process changes to ensure benefits / objectives are being met and are measurable.
• Interfacing with the Client's Business Technology and data management team and / or external vendors to facilitate system configuration based on documented Business and Functional Requirement Specifications.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Maureen : [email protected]

ALPHA'S REQUIREMENT #23-01172

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

PROJECT MANAGER FOR PHARMACEUTICAL

JERSEY CITY, NJ

This is a Remote role!

Pay ranges between $65.50 - $70.92 an hour!

Required Skills :

• Bachelor's degree + minimum 3 years of relevant experience in life sciences and process and systems related coordination.
• Project management experience.
• Experience within Veeva MI system is a plus.
• Experience in partnering with Business stakeholders across geographies and functions to inform global process design and execution.
• Expertise in executing process and systems workshops, meetings, and other methodologies to inform effective and efficient, new and updated processes and systems.
• Attention to detail, excellent communication skills and the ability to work independently, escalating risks and issues as appropriate.
• Demonstrated success in a fast-paced environment, with the ability to learn on the fly while understanding and solving new problems, requiring a high level of independent judgement and initiative.
• Ability to identify the most efficient and effective way to implement new services.
• Proven ability for innovation and non-traditional thinking.
• Strong judgement on ideas that can really lead to compliant and value adding customer solutions.
• Excellent verbal and written technical and non-technical communication.
• Outstanding facilitation skills.
• Good interpersonal and networking skills.
• Friendly, outgoing, energetic, enthusiastic, stimulating.
• Curious and constantly challenging the status quo.
• Demonstrated ability to collaborate cross-functionally and with stakeholders.
• Strong interpersonal and time management skills.
• Expert level in MS Office package, including MS Teams.
• Having worked at affiliate, regional and / or global level.
• Change management, Sigma and / or Project Management certification.

Project Description :

Medical Services Project Manager role will report to the Medical Affairs Director and will focus on coordinating projects, data and systems in support of Global Medical Affairs Capability GMAC.

• They will participate in designated point of contact (DPOC) and health information services transformational initiatives in the fast-paced and dynamic environment of GMAC.
• System Administration :
• Partnering with internal or external partners for DPOC MI system initiation, configurations which enable GMAC business process.
• Schedule business process alignment and requirement gathering workshops.
• Participating in Business / System requirements for development as well as User Acceptance Testing and Communications to stakeholders regarding system updates / upgrades.
• Draft, review and obtain approval of business requirements / user stories for Veeva MI and associated integrations.
• System Support & Process Execution :
• Accountable for systems governance such as license provisioning process and access management.
• Support system end users during hyper care period for system establishment.
• Support systems and process training roll out across the globe.
• Support SOPs reformulation, communication, and approval process. Assist in the development of training materials.
• Through these responsibilities, this role will identify opportunities for additional process improvements, innovations and system functionality enhancements / upgrades.
• Based on capacity, this role will also have the opportunity to work on other core projects within GMAC.
• Successfully partner within GMAC and across business functions and geographies to make effective decisions, solving complex problems with efficient solutions and escalating risks and issues as appropriate.
• Support for Help Desk escalations around system functionality and user roles.
• Collaborates with key stakeholders within GMAC and other internal business partners to design, develop and utilize metrics for quality and efficiency assessment and continuous improvement recommendations.
• Administrate cross-divisional governance meetings (as needed) to support meetings objectives, alignment across system users for configuration changes and release management.
• Facilitates program training and maintenance of program-related reference guides and / or training documents on both the process and the applicable system.
• Adhere to the compliance and regulatory procedures, working closely with Global Compliance and Legal.
• Responds and complies with any program investigations, audits, or assessments working closely with DPOC Director on the control plan and any audits of the process.
• Understands the business process and objectives to enable configuration decisions.
• Engages cross-functionally across the organization to develop test and implementation plans, drive results and resolve issues, using an ability to assess and course correct when necessary.
• Ability to multi-task and serve the Process & System Coordination for multiple processes and systems leveraged by GMAC.
• Implement processes utilizing improvement methodologies such as Six Sigma and / or Lean.
• Ensure efforts and priorities align to overall GMAC Strategic Initiatives while focusing on efficient, effective process execution.
• Track process changes to ensure benefits / objectives are being met and are measurable.
• Interfacing with the Client's Business Technology and data management team and / or external vendors to facilitate system configuration based on documented Business and Functional Requirement Specifications.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Maureen : [email protected]

ALPHA'S REQUIREMENT #23-01172

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

ADMINISTRATIVE ASSISTANT

LAKE COUNTY, IL

Mon-Fri : 8AM-5PM

Pay range : $19.00 22.00 / hr.

Required Skills :

• Minimum of 3 years of administrative assistant related experience.
• High school diploma or equivalent.
• Intermediate to advanced Microsoft Office Suite skills, especially Outlook, Microsoft Teams, PowerPoint, Word, Excel, OneNote, and OneDrive.
• Self-starter that uses foundational knowledge and experience to grow intuitively.
• Team-oriented, can-do attitude, collaborative partner.
• Learns quickly and can change direction if necessary.
• Open to coaching and suggestions from all team members.
• Professional demeanor and ability to maintain confidentiality.

Project Description :

• This position requires intuitive agility, detailed event planning / management abilities, collaborative leadership, and agile administrative skills.
• Support for the Vice President of Performance Operations and selected staff members including :
• Calendar management including collaborating with various departments on leader's behalf as needed to ensure smooth operations.
• Compliant and timely completion of expense reports.
• Thorough travel management through Corporate Travel website and other programs.
• Detailed event planning and management for onsite (primarily Lake County, but other HQ locations as well) and offsite events.
• Creation and routing of SOWs and POs; other budget tasks as team specific.
• Active management of email group codes / organizational charts for a large team.
• Effective coordination of teleconference (Teams, Zoom) needs; other A / V needs.
• Coordinates new employee setups and onboarding.
• Professionally interacts with high level executives and consistently handles confidential or business-sensitive information.
• Coordinate all Catering needs for LRR / SP2 meetings (hosted by Elaine Sorg) on behalf of Brand Excellence Team.
• Compiles monthly highlights for Vice President of Performance Operations.
• Prepares agendas for Vice President Leadership meetings and leads coordination of significant events for all Performance Operations.
• Leads monthly meetings and agendas for Performance Operations Admin Team fostering a collaborative culture.
• Uses intermediate to advanced software skills to performance assigned work.
• Uses and understands all software in Microsoft Office Suite, especially Outlook, Microsoft Teams, PowerPoint, Word, Excel, OneNote, and OneDrive.

This 1+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kim : [email protected]

ALPHA'S REQUIREMENT #23-01073

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE