Research
Grants & Contracts Investigator Contracts Administrator
A known branded global pharmaceutical company located
in the Northern New Jersey area seeks a contract Research
Grants & Contracts Investigator Contracts Administrator
to support all therapy areas of Clinical R&D by
drafting and negotiating investigational site contracts
with specific emphasis on indemnification, intellectual
property, publication, fraud and abuse, and FDA laws
and regulations. Job encompasses negotiating master
clinical study agreements with academic and private
institutions; tracking study site start-up metrics,
assisting CROs in the negotiation of investigational
site contracts by providing approved alternate contract
language; participating with Clinical R&D personnel
in negotiations when necessary, and coordinating with
clients, as appropriate, and legal staff on contract
and budget development. Interface with all departments
Requirements:
- JD required
- Minimum 2 years experience in clinical contracting
within the pharmaceutical industry, with specific experience
negotiating phase II & III Clinical Trial Agreements
("CTAs")
- Strong communication, organizational, and analytical
skills
- Must be able to identify, research and communicate
legal risks and issues
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Director,
Contract Management
Pharmaceutical company located in Northern New Jersey
area is seeking a Senior Manager/Director Manager to
administer the company's Federal government contract
and pricing program. Manage Contract Management in the
preparation of bids and contracts, sales reporting,
and administrative fees/rebates. Support Brand contracting
and rebate efforts.
-Manage all federal government pricing programs.
-Coordinate our Brand contracting efforts and administer
rebates.
-Coordinating bid submissions .
-Pricing Maintenance.
-Running contract performance reports.
Excellent MS Word and Excel skills, Data Entry accuracy,
and math aptitude. Ability to provide high quality results
in a timely and efficient manner. Individual is well
organized, attentive to detail, and proactive. Ability
to interact positively with customers and other trade
partners.
A Bachelor Degree is required. 5-7 years of work experience
in commercial and government contracting in pharmaceuticals
also required.
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Senior
Manager/Global Alliance Management
A known branded global pharmaceutical company located
in the Northern New Jersey area is experiencing explosive
growth and seeking a Senior Manager Global Alliance
Management to implement and provide input to the outsourcing
strategy for all functions within company. Organize
and develop the internal expertise/resources necessary
to execute the strategy and manage provider relationships
worldwide. Identified work packages and vendors for
outsourcing of activities to provide strategic guidance,
direction, and oversight to outsourcing process.
Determine and negotiate contracts and changes in scope
of global clinical studies.
Serve as the liaison between the vendor and the internal
study team to insure an interactive vendor and sponsor
relationship. Manage vendor interactions and performance
across all therapeutic areas.
Monitor service of current partners and provide performance
measures and recommendations. Provide industry analysis
by continuously monitoring the outsourcing environment.
Create and maintain outsourcing standards and procedures
for Clinical Operations. Build, engage, maintain, and
implement the first strategic sourcing initiative and
strategy for clinical services. Work with teams to plan,
track and coordinate activities and validate savings
targets. Facilitate sourcing management core teams for
clinical services including market and company research
and resulting in a strong knowledge of pharmaceutical
research resources. Provide leadership in designing
a program to support alternate sourcing practices consistent
with Sourcing Strategies, and then partner with appropriate
clinical service suppliers in implementing the strategy.
Negotiate volume discount and preferred pricing rates
with clinical suppliers in Master Services Agreements.
Qualifications:
Scientific background and expert understanding of Pharma
industry / outsourcing marketplace together with a broad
understanding and experience within the Pharmaceutical
research development environment. Deep knowledge of
vendor qualification process and vendor performance
metrics.
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Outsource
Manager
A pharmaceutical company located in Connecticut is seeking
an Outsource Manager. The primary responsibilities of
the Outsource Manager will be to manage the overall
contracting and outsourcing strategy, at a project level,
for Research and Development. The main responsibilities
are to manage the selection of and contracting with
contract research organizations (CROs), and vendors
involved in clinical research activities. The incumbent
must communicate project issues and progress regularly
to the Project Teams and functional area management.
PRINCIPAL ACCOUNTABILITIES
1. Oversee various aspects of contracting and outsourcing
for the project teams and supporting departments. Coordinate
with functional departments to understand services and
deliverables required from outside vendors.
2. Coordinate with functional groups to develop Request
for Proposal specifications including operational assumptions,
quality measures, task lists and timelines.
3. Analyze service provider proposals and prepare recommendations
to facilitate development team's selection of appropriate
vendors. Evaluation includes cost analysis, capability
assessment, and overall alignment of services with project
goals.
4. Chair proposal defense meetings and coordinate all
follow-up activities with service providers during the
evaluation and selection process.
5. Forecast and report program and project level budget
estimates. Develop investigative site budgets and exhibits
based on project level budgets and final protocols.
6. Manage CRO deliverables, including but not limited
to: Clinical Trial Agreement approval and periodic audits,
grant budget review and approval and CRO budget reconciliation.
7. Provide structured, comprehensive, and timely reports
of the status of requests for proposals, vendor qualification
activities, budget negotiations, and contracting.
8. Address CRO and vendor invoice issues until resolved.
9. Create and maintain purchase orders for CROs and
vendors.
QUALIFICATIONS
Minimum Requirements
Bachelor's Degree in business or science, or equivalent
education.
A minimum of 4-6 years previous experience in clinical
drug development or equivalent experience/education
combination.
As part of the 4-6 years, experience, a minimum of 2
years of previous clinical contracting experience in
the pharmaceutical or related industry (e.g. Biotechnology,
Medical Device, Contract Research Organization) is necessary.
Strong negotiation skills.
Strategic planning and pro-active thought processing.
Ability to analyze drug development proposals.
Excellent organizational, interpersonal and oral/written
communication skills are required.
Ability to prioritize, multi-task and work as part of
a team.
Technical proficiency with the entire Microsoft Office
suite, as well as the ability to learn and utilize new
software (i.e. SAP).
Requires the ability to prepare contracts and RFPs
for programs in the most efficient and effective manner
within a constantly changing environment. This involves
planning, organization, communication, management and
leadership skills to coordinate program personnel, and
various service groups, and to understand the complexities
of clinical research processes, regulatory issues, resource
allocation, and scheduling issues in order to aid in
the selection of the most desirable provider.
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Associate
Director/ Senior Manager Research Grants & Contracts
Associate Director/Senior Manager Research Grants &
Contracts
Grants and Contracts Department
Northern New Jersey
A well known progressive expanding global pharmaceutical
company located in Northern NJ seeks a research grants
and contracts professional to support all areas of Clinical
R&D by drafting and negotiating diverse contracts,
including agreements with study sites and vendors for
CRO services, lab services, consulting agreements, assisting
CROs in the negotiation of investigational site contracts
by providing approved alternate contract language, participating
with Clinical R&D personnel in negotiations when
necessary, and coordinating with Finance, as appropriate,
on contract and budget development
Identify and, in coordination with in-house legal staff,
advise on various contract issues arising in the Clinical
R&D area, including indemnification, intellectual
property, publication, fraud and abuse, FDA laws and
regulations
Interface with various departments
Review and evaluate, with the Study Teams, the performance
of investigational sites and vendors with respect to
quality of work, cost, communication and other relevant
parameters with an eye towards advising on future contracting
initiatives
JD or MBA required 5-8 years experience in clinical
contracting within the pharmaceutical industry. Solid
drafting and negotiation skills and experience
Strong communication, organizational, analytical and
contract drafting skills
Must be able to identify and research legal risks and
issues and effectively counsel clients regarding same
Must be comfortable working with all levels of the organization
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Manager/Senior
Manager Research Grants & Contracts
Manager -Senior Manager Research Grants & Contracts
Grants and Contracts Department
Northern New Jersey
A well known progressive expanding global pharmaceutical
company located in Northern NJ seeks a research grants
and contracts professional to support all areas of Clinical
R&D by drafting and negotiating diverse contracts,
including agreements with study sites and vendors for
CRO services, lab services, consulting agreements, assisting
CROs in the negotiation of investigational site contracts
by providing approved alternate contract language, participating
with Clinical R&D personnel in negotiations when
necessary, and coordinating with Finance, as appropriate,
on contract and budget development
Identify and, in coordination with in-house legal staff,
advise on various contract issues arising in the Clinical
R&D area, including indemnification, intellectual
property, publication, fraud and abuse, FDA laws and
regulations
Interface with various departments
Review and evaluate, with the Study Teams, the performance
of investigational sites and vendors with respect to
quality of work, cost, communication and other relevant
parameters with an eye towards advising on future contracting
initiatives
JD or MBA required 2-5 years experience in clinical
contracting within the pharmaceutical industry. Solid
drafting and negotiation skills and experience
Strong communication, organizational, analytical and
contract drafting skills
Must be able to identify and research legal risks and
issues and effectively counsel clients regarding same
Must be comfortable working with all levels of the organization
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Senior Manager/Director Contract Management
Pharmaceutical company located in Northern New Jersey
area is seeking a Senior Manager/Director Manager to
administer the company's Federal government contract
and pricing program. Manage Contract Management in the
preparation of bids and contracts, sales reporting,
and administrative fees/rebates. Support Brand contracting
and rebate efforts.
Manage all federal government pricing programs.
Coordinate our Brand contracting efforts and administer
rebates.
Coordinating bid submissions .
Pricing Maintenance.
Running contract performance reports.
Excellent MS Word and Excel skills, Data Entry accuracy,
and math aptitude. Ability to provide high quality results
in a timely and efficient manner. Individual is well
organized, attentive to detail, and proactive. Ability
to interact positively with customers and other trade
partners.
A Bachelor Degree is required. 5-7 years of work experience
in commercial and government contracting in pharmaceuticals
also required.
Apply
Now!
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