Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Apr 24, 2024
Full time
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
If you are looking for a dynamic work environment in a fast growing organization where you can make a difference, AnalytiChem might be the challenge you are seeking.We are looking for Inside Sales Manager that will be capable of handling multiple projects simultaneously and possess an adaptable personality. This candidate must have a high sense of urgency to give clients a positive experience and achieve individual and company goals. We are looking for 2 Inside Sales Managers!
Your main responsibilities:
Work on a sales team within the AnalytiChem North America group.
Understand the overall sales process, CRM system and procedures.
Establish, secure and grow relationships with assigned accounts in a specific geography.
Develop solutions to meet the needs of assigned accounts.
Develop & create new opportunities from assigned accounts.
Develop & execute business plans focused on specific account projects or industry segments.
Respond to specific RFPs or formal proposals as required. Monitor status and execute on won bids as needed.
Provide quotes, proposals and presentations to assigned accounts for specific opportunities as needed.
Travel to assigned account(s) locations as needed for client presentations and team sales meetings.
Support and assist with new business development activities as assigned to the sales team.
Other duties as assigned by the North America sales team.
Apr 22, 2024
Full time
If you are looking for a dynamic work environment in a fast growing organization where you can make a difference, AnalytiChem might be the challenge you are seeking.We are looking for Inside Sales Manager that will be capable of handling multiple projects simultaneously and possess an adaptable personality. This candidate must have a high sense of urgency to give clients a positive experience and achieve individual and company goals. We are looking for 2 Inside Sales Managers!
Your main responsibilities:
Work on a sales team within the AnalytiChem North America group.
Understand the overall sales process, CRM system and procedures.
Establish, secure and grow relationships with assigned accounts in a specific geography.
Develop solutions to meet the needs of assigned accounts.
Develop & create new opportunities from assigned accounts.
Develop & execute business plans focused on specific account projects or industry segments.
Respond to specific RFPs or formal proposals as required. Monitor status and execute on won bids as needed.
Provide quotes, proposals and presentations to assigned accounts for specific opportunities as needed.
Travel to assigned account(s) locations as needed for client presentations and team sales meetings.
Support and assist with new business development activities as assigned to the sales team.
Other duties as assigned by the North America sales team.
GEDA USA Elevator and Material Lift Co.
League City, TX 77573, USA
This position entails the below
Initiates or coordinate customer contact with sales managers, answer customer inquiries, maintain strong business relationships with customers and ensure excellent customer service.
Manage price pages/templates and quotes in conjunction with the sales manager and General Manager.
Maximizes current customer potential by using all available resources, including but not limited to CRM contact and data mining tools, to determine growth opportunities, regular contact with owners and key decision makers, developing and leveraging relationships, maintaining current knowledge of new product and market developments.
Develops and maintains a comprehensive product knowledge to support customers, and team members.
Develops leads by utilizing all available resources, including referrals, web, and other electronic media.
Assists customers in selecting equipment for their project.
Informs customer of prices, shipping date, anticipated delays, and any additional information needed by customer.
Answers questions from customers or individuals on how a product operates or direct them to the person that can assist them.
Achieves assigned performance goals and objectives as set by management to grow permanent elevator business.
Documents all relevant account activity in Salesforce.
Understands and sells to the organization’s capabilities and specifications.
Work with accounting manager to qualify new accounts from a financial/credit perspective.
Participate in trade shows as needed.
Participate in lunch & learns with EPC’s as necessary.
Travel: to jobsites and pre-bid meetings as required.
Apr 11, 2024
Full time
This position entails the below
Initiates or coordinate customer contact with sales managers, answer customer inquiries, maintain strong business relationships with customers and ensure excellent customer service.
Manage price pages/templates and quotes in conjunction with the sales manager and General Manager.
Maximizes current customer potential by using all available resources, including but not limited to CRM contact and data mining tools, to determine growth opportunities, regular contact with owners and key decision makers, developing and leveraging relationships, maintaining current knowledge of new product and market developments.
Develops and maintains a comprehensive product knowledge to support customers, and team members.
Develops leads by utilizing all available resources, including referrals, web, and other electronic media.
Assists customers in selecting equipment for their project.
Informs customer of prices, shipping date, anticipated delays, and any additional information needed by customer.
Answers questions from customers or individuals on how a product operates or direct them to the person that can assist them.
Achieves assigned performance goals and objectives as set by management to grow permanent elevator business.
Documents all relevant account activity in Salesforce.
Understands and sells to the organization’s capabilities and specifications.
Work with accounting manager to qualify new accounts from a financial/credit perspective.
Participate in trade shows as needed.
Participate in lunch & learns with EPC’s as necessary.
Travel: to jobsites and pre-bid meetings as required.
Public Utility Commission of Texas
Austin, TX 78711, USA
Perform moderately complex program management work developing, coordinating, implementing, and overseeing the Texas Energy Fund established in Texas Utilities Code Chapter 34, which promotes greater resiliency of the Texas electric grid by establishing loan and grant programs to support the construction, maintenance, and modernization of dispatchable electric generating facilities in Texas. Work involves monitoring and managing the progress, schedule, and quality of the Texas Energy Fund implementation to ensure that program deliverables are acceptable, fulfill the terms of the project contract and legislative specifications, and are completed within budget. Work requires extensive contact with internal and external stakeholders, including Commission attorneys, engineering and regulatory staff, industry representatives, the Texas Treasury Safekeeping Trust Company, and other professional staff. Work under general to limited supervision with moderate to considerable latitude for the use of initiative and independent judgment.
ESSENTIAL FUNCTIONS :
Plan, develop and implement functions of the Texas Energy Fund programs implemented under Public Utility Commission of Texas (PUCT) oversight.
Assist the Project Manager and Contract Administrator for contracts awarded as a part of the Texas Energy Fund project, specifically including oversight of the professional services firm engaged to develop and administer Texas Energy Fund programs.
Develop program information and status reports.
Develop and approve program budgets, schedules, work plans, resource requirements, and cost estimates and projections.
Review any proposed changes to program parameters and changes to original program plan and budget; track the implementation of changes.
Develop and review program plans including timelines and milestones, and contingency planning.
Assist in the development of program goals and objectives consistent with the enabling legislation and the objectives of the Texas Energy Fund programs.
Analyze data and establish criteria for evaluating programs, projects, proposals, and other pertinent information related to program assignments.
Develop and implement plans to communicate program methodology and processes to interested groups and team members.
Establish comprehensive strategies and methodologies for identifying, assessing, reporting, managing, and mitigating risk for the programs.
Monitor and manage program quality and cost to ensure that program deliverables are acceptable, fulfill the terms of the project contract or specifications, and are completed within budget.
Identify and implement process improvements in the area of program management.
Coordinate program activities with other state agencies, governmental entities, or private sector partners and contractors.
Assist with the development and management of the loan and grant application processes.
Review loan and grant applications, reports, and funds release requests.
Identify and implement process improvements throughout program administration.
Identify potential program risks and design strategies to mitigate or avoid and difficulties. Review the financial reporting associated with the Texas Energy Fund programs.
Coordinate program activities with internal and external stakeholders.
Compile and distribute program information, program status reports, and program budget expenditures. May testify before legislative and interested groups on program status and other issues of public interest.
Demonstrate a spirit of teamwork, offering positive and constructive ideas, encouragement, support to other members of the staff and team, and respond professionally to constructive feedback from others, while upholding the PUC’s mission and core values.
Adhere to all PUC personnel policies and division procedures and perform other work as assigned.
REQUIRED MINIMUM QUALIFICATIONS :
Undergraduate degree from an accredited four-year college university; and
Two (2) years of full-time program management experience supporting loans and grant management, and financial activities.
PREFERRED QUALIFICATIONS :
Undergraduate or graduate degree in finance or business.
Experience overseeing grant or loan programs with a state government agency.
Experience with regulatory, statutory, or policy analysis.
Work experience in the Texas electric utility industry.
Apr 01, 2024
Full time
Perform moderately complex program management work developing, coordinating, implementing, and overseeing the Texas Energy Fund established in Texas Utilities Code Chapter 34, which promotes greater resiliency of the Texas electric grid by establishing loan and grant programs to support the construction, maintenance, and modernization of dispatchable electric generating facilities in Texas. Work involves monitoring and managing the progress, schedule, and quality of the Texas Energy Fund implementation to ensure that program deliverables are acceptable, fulfill the terms of the project contract and legislative specifications, and are completed within budget. Work requires extensive contact with internal and external stakeholders, including Commission attorneys, engineering and regulatory staff, industry representatives, the Texas Treasury Safekeeping Trust Company, and other professional staff. Work under general to limited supervision with moderate to considerable latitude for the use of initiative and independent judgment.
ESSENTIAL FUNCTIONS :
Plan, develop and implement functions of the Texas Energy Fund programs implemented under Public Utility Commission of Texas (PUCT) oversight.
Assist the Project Manager and Contract Administrator for contracts awarded as a part of the Texas Energy Fund project, specifically including oversight of the professional services firm engaged to develop and administer Texas Energy Fund programs.
Develop program information and status reports.
Develop and approve program budgets, schedules, work plans, resource requirements, and cost estimates and projections.
Review any proposed changes to program parameters and changes to original program plan and budget; track the implementation of changes.
Develop and review program plans including timelines and milestones, and contingency planning.
Assist in the development of program goals and objectives consistent with the enabling legislation and the objectives of the Texas Energy Fund programs.
Analyze data and establish criteria for evaluating programs, projects, proposals, and other pertinent information related to program assignments.
Develop and implement plans to communicate program methodology and processes to interested groups and team members.
Establish comprehensive strategies and methodologies for identifying, assessing, reporting, managing, and mitigating risk for the programs.
Monitor and manage program quality and cost to ensure that program deliverables are acceptable, fulfill the terms of the project contract or specifications, and are completed within budget.
Identify and implement process improvements in the area of program management.
Coordinate program activities with other state agencies, governmental entities, or private sector partners and contractors.
Assist with the development and management of the loan and grant application processes.
Review loan and grant applications, reports, and funds release requests.
Identify and implement process improvements throughout program administration.
Identify potential program risks and design strategies to mitigate or avoid and difficulties. Review the financial reporting associated with the Texas Energy Fund programs.
Coordinate program activities with internal and external stakeholders.
Compile and distribute program information, program status reports, and program budget expenditures. May testify before legislative and interested groups on program status and other issues of public interest.
Demonstrate a spirit of teamwork, offering positive and constructive ideas, encouragement, support to other members of the staff and team, and respond professionally to constructive feedback from others, while upholding the PUC’s mission and core values.
Adhere to all PUC personnel policies and division procedures and perform other work as assigned.
REQUIRED MINIMUM QUALIFICATIONS :
Undergraduate degree from an accredited four-year college university; and
Two (2) years of full-time program management experience supporting loans and grant management, and financial activities.
PREFERRED QUALIFICATIONS :
Undergraduate or graduate degree in finance or business.
Experience overseeing grant or loan programs with a state government agency.
Experience with regulatory, statutory, or policy analysis.
Work experience in the Texas electric utility industry.