current open positions

Remote until COVID safe

Job Description:

Top Skill: 2 to 3 years’ Solution Architect experience with at least 4 years of prior Technical Lead experience -Preferably pharma background

Solution Architect supporting Enterprise Architect for Global Product Development and Supply (GPS) accountable for the IT enterprise landscape and strategy for functions which include: Global Supply Chain, Global Engineering/Facilities, Manufacturing Operations (Biologics, Pharmaceutical Operations, Cell Therapy), Product Development, and Global Quality.
 

The positions main responsibility will be to provide solution architecture and technical oversight to Global Product Development and Supply (GPS). The candidate will be responsible for providing overall technical management, but also be able to take responsibility to document the architecture, including conceptual, logical, data, and solution for projects.
 

Position Responsibilities
• Ability to lead and/or develop conceptual, logical and solution architectures across application, data and technology domains
• Ability to review project deliverables, including design document review, for completeness, quality, risk and compliance with established project architecture standards, enterprise standards, and business vision and expected outcomes
• Ability to define and present the architecture, e.g. conceptual, logical, data, and solution, including dependencies, to an architecture review board
• Experience designing and overseeing the implementation of solution designs, including solution integrations
• Experience in interacting with development teams, communicating design and overseeing technical implementation and deployments
• Ability to coordinate and work with multiple teams to successfully implement a solution, including, but not limited to, Integration teams, Data Architecture team, vendors and/or solution development team
• Ability to identify, document, communicate and resolve/mitigate design and system development risks and issues
 

Position Requirements
• 2 to 3 years’ Solution Architect experience with at least 4 years of prior Technical Lead experience
• Experience working with cloud technologies and architectures
• Proven analytical skills to properly turn requirements into solution architecture the meets business outcomes
• Proven analytical skills to properly evaluate vendor solution architecture
 

• Good understanding of master data strategies, data lakes, and information hubs
• Experience across domains: Security, Network, Infrastructure, Data, and Cloud solutions
• Ability to clearly communicate architecture decisions, risks and benefits to all levels of the business.
• Ability to work within a project team
• Able to manage technical activities for a cross functional technical team.
• Strong presentation, verbal and written communications skills
• Must exhibit ability to be collaborative and results oriented
• Ability to work independently
• Knowledge of EA methodologies, standards, practices, governance and reference patterns is a plus

Location:  Princeton, NJ

Job Description:

Veeva Enterprise - IT DCM for Multichannel CRM Capabilities: Role will be responsible for shaping, delivering & supporting Veeva Multichannel CRM capabilities & road maps for Commercialization field forces (i.e. Sales, Medical & Access) in partnership with IT Plan, Business Stakeholders, Technology Partners and other matrix team members in the US & ex-US (as required).

Responsibilities:

• Work as the primary liaison between IT Plan and/or Business teams and other matrix IT Delivery teams to analyze & validate published requirements to deliver technical solutions for Multichannel CRM Capabilities such as Approved Email, CLM & IVAs, Consent Capture and Vault PromoMats
• Design & develop cost effective solutions that meet functional, technical, security and performance requirements which also adhere to platform design standards & release management process
• Lead, plan & deliver new and/or existing strategic platform capabilities that create tangible business value
• Collaborate with matrix teams to shape & drive platform roadmap in support of business & platform needs
• Collaborate with matrix teams (i.e. Business, IT, Security, External Vendors, etc.) to ensure smooth execution of programs, projects and support activities to meet business needs
• Assist and/or manage requests from IT Plan (for IT Investments) and via Operational Change Board(s)
• Oversee multiple projects across different business units (i.e. Commercial, Medical and Access) while supporting cross-functional activities related to product launches/line extensions, field re-alignments and other Commercialization field endeavors
• Execute & manage IT vendor contract(s) and Service Order(s) as needed
• Ensure management & control of IT project and / or operational financials and budgets as needed
• Partner with external platform partners/vendors to influence & drive their product roadmaps
• Ensure technical solutions are compliant with BMS policies, procedures and regulations
• Identify, clarify, and resolve system development and/or maintenance activity issues and risks, escalating them as needed

General Requirements:
• Bachelor’s degree required
• 5+ years’ experience with Veeva Multichannel CRM capabilities (i.e. Approved Email, CLM & IVAs, Consent Capture, Vault PromoMats, etc.)
• Hands-on experience and/or strong understanding of Veeva Vault PromoMats
• Experience supporting Commercial, Medical and/or Access field force systems
• Experience using Agile practices & methodologies
• Understanding of master data strategies and information hubs a plus
• Proven leadership and decision making skills
• Strong presentation, verbal & written skills to deliver clear & transparent communications
• Think strategically while delivering tactically
• Can communicate the “big picture” in terms of overall solution (both functional & technical components) and break it down into smaller manageable work units
• Strong analytical and problem solving skills
• Comfortable managing multiple complex initiatives in fast paced dynamic environment
• Comfortable working with limited direction and/or independently
• High energy and works with sense of urgency
• Proficient in MS Office

Location:  Princeton, NJ

Job Description:   Top Skill: 

Atlassian JIRA | Product Sales | Microsoft Project |   Project Management | Budgeting | Kanban | Conflict Management | Agile   Coaching | Project Planning and Development Skills | Change Management |   Software Development | Empower | Product owner | Scrum Master | Agile   Development

The IT Project Manager/SCUM Master is responsible for providing project management coordination, support, and assistance in all aspects of projects and programs. Works primarily with senior level internal clients.  This includes project planning, execution, timing, functionality, quality, communication and cost (overall accountability from original concept through the final implementation of IT solutions).  Managing on-time and on-budget delivery of new and enhanced business capabilities that meet or exceed expectations is an integral part of the role. Responsible for global projects.  Financial responsibility to meet budget and financial goals. Demonstrated and proven delivery track of large scale programs. Technical background. 

Manages daily stand up meetings, reviews, retrospectives, sprint planning, demos, and other scrum related activities.

Tracks and communicate scrum metrics including team velocity and sprint/release progress.

Ensures Agile/scrum concepts and principles are adhered to including continuous integration builds and coaches team in implementing and practicing Agile Principles and methods.

Helps the product owner establish and enforce sprint priorities and release delivery deadlines.

Designs optimal solutions and prevent distractions that interfere with the ability of the team to deliver the sprint goals.

Ensures business objectives are understood and achieved.

Holds teams accountable for meeting iteration/sprint commitments.

Mediates, arbitrate, mitigate and facilitates impediments with the team members and the organizational hierarchy.

Works to get the job done, which may include some development.

Assists with internal and external communication, improving transparency and radiating information.

Supports team building and development by utilizing the abilities and skills of individuals, which can include:

Empowers and supporting self-organization

Facilitates discussion and conflict resolution

Fosters feedback culture

Promotes collaboration between many self-organizing, cross-functional development teams

Facilitates methods for the team to seek higher productivity levels

Maintains awareness of other development teams’ overall roadmap plan, decreasing the possibility of duplicate work being done between teams

Promotes and educates the entire organization to understand AGILE principlesOversee, Prepare, and/or Review aggregate safety review documents (eg, DSUR, PBRER) and safety sections of relevant clinical trial documents (eg, protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
• Lead the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety activities and benefit-risk strategies for assigned BMS compound(s)/ program and chair the product SMT(s) as required.
• Assist the team and senior management in all forms of issue management and crisis management

Location: Austin, TX

    Job Description:
• Oversee, Prepare, and/or Review aggregate safety review documents (eg, DSUR, PBRER) and safety sections of relevant clinical trial documents (eg, protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
• Lead the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety activities and benefit-risk strategies for assigned BMS compound(s)/ program and chair the product SMT(s) as required.
• Assist the team and senior management in all forms of issue management and crisis management

Location: Princeton , NJ

    To perform the duties of this job, the candidate must have:

- Experience in cross functional project management (preferably CMC)
- Familiarity with end to end CMC drug development with an understanding of critical milestones and typical bottlenecks
- Ability to develop strong collaborative working relationships with stakeholders and across technical functions to drive efficient execution of CMC program strategy
- Strong organizational, interpersonal & communication skills, be agile, display an enthusiastic and collaborative attitude with peers and team members
Scope:
The Senior CMC Project Manager is closely partnered with the CMC Team Leader to enable effective development and execution of integrated CMC strategy and plans.
The scope of responsibilities of the Sen. CMC Project Manager fall into 5 general categories which flex across all drug modalities, disease areas and stages of development:
 

- Cross-functional CMC team Management, including meeting planning, facilitation and documentation
- Integrated CMC Project Plan Management, including maintenance of up-to-date project timelines and timeline scenario planning
- Gaps Analysis and Risks Management
- Planning and allocation of CMC drug material demand for non-clinical use
- Ensure accuracy of PM-related information in established portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management
 

Project Manager Job Description:
- CMC PM is a leader, coordinator, and facilitator for the Portfolio Strategy and Integration (PSI) organization , providing tactical direction, managing teams, and providing tactical solutions that support the overall program strategy developed by the Integrated CMC team
- CMC PM is expected to manage 4-5 development assets (actual number determined by level of project complexity and candidate experience) and drive execution of program strategy by fostering communication and integration of all functional area representatives on the integrated CMC development team
- Establish strong partnership with CMC Team Leader to shape the overall strategy and ensure successful execution of early to late stage programs in product development portfolio the comprises of small and large molecules
-Facilitate cross-functional CMC team meetings using meeting management best practices to drive timely and effective decision-making and successful execution of program objectives
-Create and manage all integrated CMC meeting logistics including the creation of clear and concise meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team
-Responsible for the development of a detailed CMC project plan that is aligned with the overall program strategy
-Leverage established portfolio and program management tools to track program execution, milestones, risks, and long range planning to ensure appropriate communication to team members and management. Examples of these tolls include (CMC Database, OnePager Pro, MS Project, ePlan/Planisware, DOI Tool, Right First Time Scorecard, Operational Risk Management)
- Work collaboratively with the CMC team Leaders and functional leaders to track the critical operational aspects of the program(s), including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of project objectives which roll up to the Product Development BOW
-Responsible for contributing to the definition and execution of risk management strategies, contingency planning, supporting the development of a high performing team(s), and communication of the solutions to management
-Partner with the CMC team Leader to facilitate the management of risk by scheduling meetings with the CMC teams as appropriate
- Coordinate and ensure appropriate allocation of drug substance and API materials for non-clinical use.
Experience / Qualifications:
• Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience, Masters’ degree or PhD with a minimum of 3-5 years of relevant experience
• Highly motivated self-starter that works well both in teams as well as independently
• Strong project management, business process management, and optimization skills
• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment
• Demonstrated ability to accomplish results and meet deadlines and commitments
• Strong interpersonal and communications skills, both oral a written
• Demonstrated analytical and logic skills with a focus on fact-based decision-making
• Demonstrated proficiency in MS Project, PowerPoint, Excel and Word
• Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement
• Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred

Location: New Brunswick, New Jersey

  MATLAB, Bioinformatics background

The Immunology Quantitative Systems Pharmacology (QSP) group is searching for a highly motivated scientist to develop and apply innovative translational modeling & simulation approaches in the Immunology disease area. QSP models are mathematical models that are used to integrate knowledge and data on disease pathophysiology and drug pharmacology in a mechanistic manner.

This enables hypothesis testing and generation in target discovery, translational pharmacology and clinical drug development. This position is an exciting opportunity to broadly impact critical decision making in the progression of multi-target drug R&D in Immunology. The successful scientist will be working on a highly stimulating and collaborative environment with biologists, clinicians, pharmacometricians, translational medicine scientists, and in-house QSP modelers.

Position Responsibilities:
• Drive development and application of novel QSP Immunology models to facilitate back-translation efforts from internal late development programs.
• Function as part of team to develop and rigorously assess the functionality, feasibility, efficiency and validity of new models.
• Conduct extensive literature review to identify suitable mechanistic elements, interactions, rate constants and sub-modules for incorporation into larger systems (pharmacodynamic & efficacy) models.
• Leverage algorithms for parameter optimization and sensitivity analysis.
• Analyze model predictions and identify suitable strategies to resolve issues (whenever occur) pertaining to model performance and inaccuracy.
• Network as appropriate with experts in Translational Medicine, Discovery Biology, Clinical Development, and other groups to share learnings that maximize the translational value of QSP modeling.
• Participate in internal scientific (QSP-related) discussions.
• Build and maintain QSP expertise through a personal track record of publication, attendance/participation in conferences, scientific workshops, etc.

Degree requirements:
Ph.D. in Engineering, Mathematics, Bioinformatics, Pharmacometrics, Systems Biology/Pharmacology or a related field with a proven record of productivity as demonstrated by publications and conference presentations.

Key Competency Requirements:
• Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs).
• Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research would be particularly desirable.
• Excellent oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude.
• Hands-on experience with modeling software like MATLAB is required.
• Experience with general programming and data analysis tools/languages such as R would be particularly desirable.
• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistic disease/pharmacology models.
• Good understanding of the basic principles of pharmacokinetics and pharmacodynamics.
• Candidates with previous (academic or industry) experience in QSP or a closely related field are highly encouraged to apply.

Location: Lawrenceville, New Jersey

• Support Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.

Qualifications:

• Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical   development or QA, with a minimum of 5 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
• At least a bachelor’s degree required. Master’s Degree or PhD preferred

Skills/Knowledge Required:
• Extensive experience with Biologic/Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
• Experience with CMC regulations for biological compounds
• Experience with Gene/Cell/CAR T Cell therapy CMC regulations
• Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
• Practical knowledge of rest of world post approval guidelines
• Have a solution-oriented approach to problem solving
• Expertise in the drug development process and post approval activities
• Ability to work on complex projects and within cross-functional teams

Location: Summit, New Jersey

Many of our job opportunities  are at client site. Datasoft Solutions offers  outstanding benefits  and a great working environment. If you feel you have a skill set Datasoft can utilize , please send your resume to:   HR@DataSoftSol.com

Datasoft Solutions, LLC is an Equal Opportunity & an "e-Verify" company.