Jobs in Management

Label Project Coordinator 9
TekWissen LLC    12-06-2019 Indianapolis, IN, USA

Job Description: 

  • Support Team Leader in the coordination of translation services, proof creating and routing services. 
  • Handle day-to-day communications with internal clients 
  • Understand and can train new employees on all LPC SOPs 
  • Primary point of contact for all label projects 
  • Proactively communicates to Team Leader all job timelines, target dates, and issues 
  • Knowledge of, and maintenance of, all Clintrak products and services 
  • Manage all requests for new proofs from the client and drive project timelines in alignment with client expectations 
  • Resolve client issues independently 
  • Route all Links/Rands approval notices to client and coordinate approval with Clintrak 
  • Meets or exceeds all applicable metrics/goals 
  • Conducts all activities in a safe manner 
  • Other duties may be assigned to meet business needs. 
  • Demonstrates and drives the Four I Values (Integrity, Intensity, Innovation and Involvement) 

Minimum Qualifications: 

  • Associates Degree or a combination of applicable education and experience 
  • Two years experience in the Microsoft Office Suite 

Preferred Qualifications: 

  • Clinical Packaging/Labeling experience 
  • Adobe Pro/Adobe Acrobat experience helpful 
  • Two years project management experience desirable 
  • Two years Label Design experience strongly desirable 
Clinical Trials Manager III 6
TekWissen LLC    12-03-2019 Foster City, CA, USA
Overview: 
 
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of Our clients who offer a biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
 

Position: Clinical Trials Manager - III 

Duration:   12 Months  

Location: Foster City California  

 

Description: 

 

  • Must meet all requirements for Clinical Trials Manager and have demonstrated proficiency in all relevant areas.  
  • In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.  
  • Coaches members of a work team and ensures adherence to established guidelines. 
  • Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.  
  • Anticipates obstacles and client difficulties and implements solutions to achieve project goals. Assists CPM in revising project timelines/budgets as necessary.  
  • Works with management on departmental issues, providing input to clinical operations strategies and work plans. 
  • Communicates with functional peers regarding project status and issues and ensure project team goals are met.  
  • Contributes to the development of abstracts, presentations, and manuscripts. 
  • Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.Participate in training of CPAs and CRAs.  
  • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.  
  • Travel is required.
  • Excellent interpersonal skills and demonstrated ability to lead is required.  
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.  
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary.  
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.  
  • Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.  
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials are required.  
  • Experience in developing RFPs and selection and management of CROs/vendors. 
  •  Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.  
  • Ability to examine functional issues from a broader organizational perspective.  
  • Functional expertise to initiate, author, or contribute to SOP development, implementation, and training 

 

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity. 

Manager Payroll & Tax Compliance 7
TekWissen LLC    12-02-2019 Milwaukee, WI, USA
Overview:
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a technology and multi-industrial company which operates in building efficiency, automotive experience, and power solutions businesses. The Company designs, sells, controls and installs heating, ventilating, air conditioning systems, batteries, electronic security systems, and fire detection and suppression systems. It also provides residential air conditioning and heating systems, and industrial refrigeration products, as well as technical and energy management consulting services.  
 
 
 
Description: 
  • 7 years minimum experience with Payroll Tax
  • Experience with researching and filing tax notices received from the IRS
  • Experience with preparing and defending challenges to tax audits
  • Experience with multi-state tax processing and filings
  • Experience working the ADP or Workday software a plus
  • Strong leadership, coordination, and coaching skills
  • Requires general understanding of accounting principles
  • Experience applying business process improvement, cost reduction and efficiency programs
  • Ability to lead and motivate others without formal authority
  • Excellent oral and written communication skills and interpersonal skills
  • Multi-state payroll tax return filing and payment experience
  • Must have high volume experience in multi-state payroll taxes
  • Experience in Microsoft Office suite applications
  • High Technical skills in Tax matters
  • Former IRS professionals are a good match
  • Must be very capable of year-end Tax processes
  • Must be knowledgeable and experienced in registering new localities and working with other tax agencies
Questions (Required):
  • Minimum 7 years of payroll tax experience.
  • ADP or Workday software experience
  • Associates degree 
  • Any payroll certification
  • Multi-state tax processing experience.
Program Manager-IT 4
TekWissen LLC    12-02-2019 Milwaukee, WI, USA
Overview:
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a technology and multi-industrial company which operates in building efficiency, automotive experience, and power solutions businesses. The Company designs sell, controls and install heating, ventilating, air conditioning systems, batteries, electronic security systems, and fire detection and suppression systems. It also provides residential air conditioning and heating systems, and industrial refrigeration products, as well as technical and energy management consulting services.  
 
Description:
? 8+ years of experience.
? Knowledge of experience in project planning, financial management, change management, interpersonal skills, communication, team management, leadership, client service management, risk management, and contract/subcontract management.
 
Key responsibilities:
? Drive implementation and delivery of the client Digital Vault Platform
? Lead agile engineering and design teams to coordinate, prioritize and deliver compelling platform capabilities
? Understand service inter-dependencies and lead cross-functional teams towards technical solutions for multi-tiered systems
? Clarify, prioritize and drive project commitments as well as establish and maintain clear chains of accountability
? Articulate program goals, desired outcomes, risks/issues, and mitigation plan clearly
? Ability to consume and communicate complex processes into tangible and actionable items 
 
Questions(Required):
  • Min 8 years of program management experience
  • Bachelors degree 
  • IT industry experience 
IT Program Manager 28
TekWissen LLC    11-26-2019 Milwaukee, WI, USA

Overview: 

 

Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a technology and multi-industrial company which operates in building efficiency, automotive experience, and power solutions businesses. The Company designs sell, controls and install heating, ventilating, air conditioning systems, batteries, electronic security systems, and fire detection and suppression systems. It also provides residential air conditioning and heating systems, and industrial refrigeration products, as well as technical and energy management consulting services.  

 

 

 

Description: 

  • 8+ years of experience. 
  • Knowledge of experience in project planning, financial management, change management, interpersonal skills, communication, team management, leadership, client service management, risk management, and contract/subcontract management. 

 

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

Product Manager 19
TekWissen LLC    11-25-2019 South San Francisco, CA, USA

Job Description: 

  • Analyze market trends, customer requirements, and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation.  
  • Lead new product development from concept through commercialization, including the voice of customer research, the definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support, and sales. 
  • The selected candidate will be a strong individual within cross-functional teams developing the right product to fill market needs and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates.  
  • The selected candidate will partner closely with the other Product Managers and Marketing Specialists to ensure system synergies and optimal customer experiences. 
  • Desired applicants must bring deep knowledge of regulated instruments space and must have experience with regulatory submissions at least in the US and China. 
  • Knowledge of biological sciences, engineering and/or genomics is highly desirable.  
  • Candidate must possess a track record of success in product development (like the voice of the customer, business plan development, financial modeling), building/leading cross-functional teams and effective executive-level communication. 

 

Key Responsibilities: 

  • Lead product definition teams conducting Voice of Customer, defining critical customer and product requirement documents with prioritized features and corresponding business or financial justification with ROI. 
  • Lead business plan and financial model development for the products. 
  • Understand, follow and be accountable for business aspects of Product Commercialization Process (PCP) for products 
  • Work closely with the regulatory team to establish a regulatory strategy that meets the regulatory needs of individual countries and be accountable for executing that strategy 
  • Assess and evaluate competitive landscape – including product offerings 
  • Accurate market analysis, value proposition, and forecasting for new products 
  • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups 
  • Set pricing to meet revenue and profitability goals 
  • Develop customer-oriented sales tools and collateral in partnership with market development 
  • Contribute to overarching solutions strategy and roadmap 
  • Resolve ambiguity for the team members and develop solutions 
  • May be required to perform other related duties as required and/or assigned 

Required Qualifications: 

  • 7+ years’ experience in Product Management required with 4+ years’ experience in regulated instruments Product Management required 
  • Bachelor’s degree in Biology, Biochemistry, Science OR Bachelor’s degree in business, marketing, or related degree 
  • Outstanding written and verbal communication skills are required 
  • Track record of success in launching solution-oriented products as a system required 
  • Demonstrated ability to develop business cases, financial model, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User-Centered Innovation inputs 
  • Demonstrated experience successfully managing products, pricing, and forecasting 
  • Strong leadership skills within cross-functional teams; a demonstrated leader through influence with strong negotiation skills 
  • Is customer-centric and keenly aware of markets, trends, and competitors 
  • Is authentic, transparent and leads by example, holding self and others accountable 
  • Organized with strong project management skills 
  • Demonstrates a sense of urgency, contagious optimism and a “can-do” attitude 
  • Inspires motivates and collaborates with others; team-first attitude 
  • Stretches across borders, break silos and builds effective partnerships with customers and colleagues 

Preferred Qualification: 

  • MBA strongly preferred 
Project Manager-I 33
TekWissen LLC    11-20-2019 Titusville, Hopewell Township, NJ 08560, USA

Job Description: 

Providing administrative support and project management for medical affairs. 
 
Responsibilities 

  • General project management support and administration to include:  Excel spreadsheet creation and management, specifically to manage customer lists and  contact information, as well as conference schedules and appointments 
  • Communications (written and verbal) with external customers including national thought leaders, professional societies, advocacy organizations, and academic organizations meeting scheduling and coordination with internal marketing personnel 
  • Conference planning and coordination management and execution of details 
  •  Internal dissemination of plans to medical affairs team and additional stakeholders 
  • Update and maintain existing databases to support medical affairs needs 
  • Planning and execution of teleconferences and web-meetings, as required 
  • On-site meeting planning and execution, as needed (15% travel) 
  • Developmental projects, as agreed upon with supervisor 
  • May be required to work on-site with a client up to 100% of the time 

 

Desired skills and traits 

  • Strong business/marketing skillset, excellent verbal and written communication, above-average PowerPoint and Excel skills, efficient time management, ability to work both independently and in a team setting, self-starter with a strong work ethic and the ability to multi-task, desire to grow with the organization. 
  • Interest or experience in medicine, nursing, health care, pharma/biotech, or experience with a company with significant vendor relationship with pharma/biotech (meetings/convention services,  advertising, public relations, agency of record). 

Education 

  • Minimum of BS or BA; RN/LPN experience may be considered. 
Program Manager-Professional 29
TekWissen LLC    11-19-2019 Boca Raton, FL, USA

Description 
What you will do  

  • The Solution Lifecycle Senior Program Manager will manage and lead a portfolio of revenue-generating new product introduction (NPI) programs for Sensormatic Solutions by the client.  
  • The programs will focus on improving our ability to deliver consistent and standardized NPI hardware, software, services and third-party solutions for Loss Prevention, Traffic Insights and Inventory Intelligence business units on behalf of the Solution Lifecycle Portfolio Management Office. 
  •  Key program deliverables include pro-actively managing and leading end to end cross-functional workstream pre-development, development, and end to end go-to-market strategic project deliverables to launch.  
  • Here are some of the end to end deliverables the Solution Lifecycle Program Manager will support in this new process framework: 

 

Pre-Development: 

  • Business Case 
  • Business Capital Appropriation Request 
  • Business Requirements 
Development: 
  • Solution Development 
  • Manufacturing 
  • Functional Requirements 
  • Third-Party Management 
  • Quality Assurance/Testing 
  • Tooling Capital Appropriation Request 
  • Hardware Certification in various markets 

 

End to End Go-to-Market: 

  • Pricing 
  • Sales Readiness 
  • Market Readiness/Promotions 
  • Training/Education 
  • Professional Services 
  • Day 2 Support/Delivery Readiness 
  • Legal Contracts 
  • Early Adopter Program/Customer Pilots 

Working in collaboration with the Solution Lifecycle Portfolio Management Office, Strategy Management Office, Marketing, Sales, Finance, Field Operations, and domain subject matter experts as an individual contributor, the Solution Lifecycle Program Manager will lead teams throughout the program management process ensuring each function manages their deliverables in order to meet the program schedule, scope, and budget. 
The Solution Lifecycle Program Manager will also represent the Solution Lifecycle Portfolio Management Office at regular accountability meetings and will be responsible for clearly and concisely presenting the status of all assigned programs to groups of leaders and key stakeholders. 
 Works under minimal supervision and in conjunction with leaders across all functional groups. Acts independently to resolve challenges and to address opportunities related to the program.  
Work is highly strategic in nature. 

 

How you will do it 

  • Work with functional and operational group leadership to identify program scope, schedule, resources, and business case 
  • Lead program kick-off to assemble team, provide program overview including scope, schedule and communicate team member expectations 
  • Lead team meetings with all functional areas to track progress, identify issues and develop action plans 
  • Adhere to the Solution Lifecycle Portfolio Management Office processes, holding team members accountable for their deliverables in accordance with requirements and verifying completion of each deliverable 
  • Manage issues, risks, and opportunities, assisting team members in removing roadblocks and escalating to management issues that cannot be resolved 
  • Manage the program schedule documenting detailed tasks for each functional area, responsibility for the task, begin and end dates, and percent complete 
  • Identify critical path and track weekly to ensure the schedule is maintained, and document actions to recover programs that are behind the track 
  • Manage the program scope, ensuring that any scope changes are documented, communicated and approved prior to including in schedule 
  • Prepare for and report on program status at Program Reviews communicating progress on any prior month identified issues 
  • Ensure open communication with the Solution Lifecycle Portfolio Management Office, providing information when requested, escalating issues that are not being resolved by management and identifying any process continuous improvement opportunities 
  • Adapt communication style in response to varying situations, groups, and cultures 
  • Engage and inform others to ensure the desired outcome 
  • Adjust efforts and approaches to meet goals and deadlines 
  • Identify and remove obstacles that may interfere with success 
  • Ensure that individuals and team members understand the impact of their contributions 
  • Use structured analysis to assess and mitigate risk 
  • Awareness of EOL strategy across business units 

What we look for 
 
Required 

  • PMP Certification or equivalent 
  • Agile / Scrum Certification or equivalent experience 
  • Minimum of 6+ years of experience managing programs/projects OR experience working on a program team as a functional lead 
  • Ability to communicate effectively in a technical environment, including in front of C-level and VP-level stakeholders 
  • Demonstrated organizational skills, including project planning, project management, and team building 
  • Experience and proficient use of Microsoft Outlook, PowerPoint, Word, Excel, SharePoint 
  • Experience and proficient use of Daptiv 
  • Excellent understanding of financial concepts 
  • Ability to travel up to 10-15%, especially during the onboarding process 

Preferred (All Not Required) 

  • Waterfall 
  • Experience working in distributed field-based organizations 

Education: 

 Bachelor’s degree in Engineering, Business, or a related field or equivalent experience  

Associate Compliance Manager II 30
TekWissen LLC    11-18-2019 Foster City, CA, USA

Overview: Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is to one of Our clients who offer a biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi

 

PDM QA - Supplier Management and Audits
 
 
Internal Audit Program and GMP Walkthrough
 
 Assist in the internal audit lifecycle activities for internal audits including scheduling, audit team assignment, audit preparation, audit agenda issuance, audit execution, drafting audit report and issuance, response/CAPA assessment and closure.
• Assist in managing contractors/consultants that support the Internal Audit Program. Ensure that they have the required skills, training and procedural qualification requirements including required consultant documentation
• Participate in the development, implementation and maintenance of procedures, systems and templates to assist in the Internal Audit Program. 
 
Affiliates Audit Program
 
• Assist in the management of client Affiliate Program including audit scheduling, audit team assignment, audit preparation audit agenda issuance, audit execution, drafting audit report and issuance, response/CAPA assessment and closure.
• Develop tools to improve efficiency and consistency in the Affiliates Audit Program
• Participate in the development, implementation, and maintenance of procedures, systems and templates to assist in the Affiliates Audit Program. 
 
 
Inspection Readiness Program (including PAI Readiness)
 
• Actively participate in designing an effective and holistic Inspection Readiness Plan for GSI FC and assist with drafting proposal for Sr. Management for review and approval
• Manages the logistics to support regulatory inspections at GSI FC including notification of management, key stakeholders, extended inspection readiness team (IRT), prep room and inspection rooms set-up and post inspection activities
• Assist in socialization of Inspection Readiness Plan to select key stakeholders and evaluate their feedback for incorporation
• Maintenance of inspection readiness tools including notification emails, playbooks, IR questionnaire, checklist and binders
• Collaboratively working with internal GSI FC key stakeholders regarding inspection readiness preparation activities including training and identification of inspection focus areas
• Assist in solidifying post-inspection activities including GTrack entries, CAPA tracking, lessons learned and response submission
• Develop and deliver training materials for inspection readiness
• Assist in putting together a GSI FC Master Inspection Binder including site master file, opening presentation, SOP list, inspection readiness team matrix , product/process stewards etc.
• Assist in finalizing and qualifying inspection support team members based on new roles and qualifications – may include management proposal, interview, evaluation of current members.
 
 
 

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.

Program Manager-Professional 20
TekWissen LLC    11-18-2019 Milwaukee, WI, USA
Job Details:
 
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a technology and multi-industrial company which operates in building efficiency, automotive experience, and power solutions businesses. The Company designs, sells, controls and installs heating, ventilating, air conditioning systems, batteries, electronic security systems, and fire detection and suppression systems. It also provides residential air conditioning and heating systems, and industrial refrigeration products, as well as technical and energy management consulting services.
 
 
Job Description:
 
Global Program Manager of HVAC and Fire programs for client Global Sales Support Center of Excellence network.
Responsibilities will include the management of design, installation, maintenance and specification development tasks in support of client global clients.
 
Duties and Responsibilities:
 
Leading, planning, directing, and monitoring all program activities in coordination with the account manager, including technical performance and financial profitability under the terms and conditions of the contractual specifications and requirements to ensure optimum profit and customer satisfaction.
Ensuring contractual and corporate compliance for the account worldwide.
Providing leadership to train and direct multi-disciplined technical and administrative personnel (including subcontractors) to resolve engineering, administrative and field issues occurring during project implementation and installation.
Coach and mentor technical and project team members on effective project management practices and techniques.
Serving as a customer interface to effectively communicate and ensure customer satisfaction.
Working with the global strategic account manager and customer to obtain additional business and identifying and pursuing new opportunities for contract revenue growth. Manages/directs proposal efforts for program growth or new opportunities by identifying and coordinating with regional resources across all regions.
Leading work teams in a continuous improvement environment with quality tools, behaviors and practices.
Performing other duties as assigned.
 
What we look for:
 
Five (5) to (7) years of direct experience with HVAC projects / program management and/or program administration.
ASIS CCP, PMI, PMP, or other equivalent certifications desired.
Proven team leader capabilities and experience dealing with large construction projects.
Travel may be required in support of program. Up to 20%.
Must possess strong skills in presentations, reporting, and effective writing; risk management/decision making skills; and strong problem-solving skills.
Ability to influence customers.
 
Education:
 
Bachelor’s Degree in Engineering, or Construction Management preferred.
 
7 years HVAC Projects/ Program Management Experience.
ASIS CCP/ PMI/ PMP, Certification.

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