Messages In This Digest (4 Messages)
- 1.
- Fw: Analyst with Learning management system, 6 months, New Brunswick From: chunili2000@yahoo.com
- 2.
- Manager, Pharmacovigilance - Parsippany, NJ From: Abby Kohut
- 3.
- Medical Science Liaisons - NJ/NY From: Abby Kohut
- 4a.
- Director of Compliance - Parsippany, NJ From: Abby Kohut
Messages
- 1.
-
Fw: Analyst with Learning management system, 6 months, New Brunswick
Posted by: "chunili2000@yahoo.com" chunili2000@yahoo.com chunili2000
Tue Dec 28, 2010 11:17 am (PST)
Please contact the recruiter Veenu directly.
Good luck!
Chuni Li
----- Forwarded Message ----
From: "vmalik@ncstech.com " <vmalik@ncstech.com >
To: chunili2000@yahoo.com
Sent: Tue, December 28, 2010 1:39:50 PM
Subject: re: Analyst with Learning management system
Hello Chuni,
My name is Veenu and I'm an IT Recruiter at NCS Technologies. Our Client is
looking for Analyst with Learning Management System for 6 months
Location: NEW BRUNSWICK, NJ.
We are looking for a contractor who has experience implementing & maintaining
learning management systems. This particular project is an implementation of
Kaplan Eduneering's ComplicaceWire, therefore we are looking to primarily find a
resource with previous ComplianceWire implementation/maintenance experience.
Responsibilities - Serves as liaison between business community and the IT
organization in order to provide technical solutions to meet user needs. -
Posses expertise in the business unit(s) they support, as well as, an
understanding of the IT organization systems and capabilities. - Analyses
business partner?s operations to understand their strengths and weaknesses to
determine opportunities to automate processes and functions. - Assists in the
business process redesign and documentation as needed for new technology. -
Translates high level business requirement into functional specification for the
IT organization and manages change to such specifications. - Educates the IT
organization on the direction of the new business. - Negotiates agreements and
commitments by facilitating communication between business unit(s) and IT from
initial requirements to final implementation. - Possess and understanding of
technological trends and uses this knowledge to bring solution o business units
supported to enhance the enterprise?s completive edge. - Works independently or
as a part of a team under general supervision, may coach junior technical staff.
Methodology/Certification - Bachelor?s Degree in Computer Science, information
Systems, Business Administration, or related field - or equivalent work
experience Experience Requirements per Category BA ? Senior - 10 years of custom
product development experience - 3 years of Pharmaceutical experience.
If you are available, interested, planning to make a change, or know of a friend
who might have the required qualifications and interest, please call me ASAP at
(732) 562-8880 Ext.4145. If you do respond via e-mail please include a daytime
phone number so I can reach you.
Thank you,
Veenu Malik
Technical Recruiter
NCS Technologies, Inc.
15 Corporate Place South
Piscataway, NJ 08854
Office: (732) 562-8880 ext 4145
Fax: (732) 562-8883
vmalik@ncstech.com
www.ncstech.com
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If you are not currently seeking employment, or if you would prefer I contact
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- 2.
-
Manager, Pharmacovigilance - Parsippany, NJ
Posted by: "Abby Kohut" abbykohut@yahoo.com abbykohut
Tue Dec 28, 2010 6:42 pm (PST)
Manager, Pharmacovigilance
LEO Pharma Inc. is a leading global pharmaceutical company specializing in
dermatology and critical care. For 100+ years, our products have improved the
quality of millions of people's lives around the world.
Headquartered in Denmark, we have employees in 50+ countries and our products
are sold in more than 100 countries. To realize our vision of becoming the
world’s leading specialty pharmaceutical company within our focus areas, we are
expanding into new regions and markets, reaching more patients and societies
with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and
creative people who are passionate about what they do, and who are determined to
make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we are recruiting a Manager,
Pharmacovigilance who will be responsible for all drug safety for the U.S.,
ensuring that people, processes and systems are established. You will ensure
compliance with global regulations and optimizing patient and product safety,
while interfacing between local and global drug safety organizations. You will
be recognized as a strong scientific/medical partner and will therefore
participate in reviewing local reports.
Responsibilities:
· Develop, enhance and modify local pharmacovigilance SOPs,
processes and systems necessary to capture, handle, resolve and report as
appropriate.
· Identify significant drug safety trends and reports.
· Contribute to research strategy within the product team and for
clinical research.
· Support preparation of PSUR and development of risk management
plans
· Support relationships with key leaders in observational research
· Provide input into observational, IIS and other LEO supported
research department meetings
· Stay abreast of the latest developments in the field drug
development and safety and in local/regional PV legislation
· Assist in developing and training (including documenting) local
staff on PV
. At all times be in compliance with corporate quality standards,
corporate timelines and global regulations.
· Handle investigational and post-marketed Individual Case Safety
Reports (ICSR) and Other Experiences (OE)
· Handle procedural oversight of investigational and marketed
safety data processing and reporting
· Receipt of quality/customer complaints linked to ICSR/OEs for
assessment and forwarding to HQ
· Assist in gathering of follow-up, as necessary, and information
to customers
· Oversee and/or directly perform local review of aggregate
reports, ad hoc and validated custom reports for use in analysis or reporting to
Competent Authority(ies)
· Supply 24-hour coverage for responding to local safety enquires
· Ensure and demonstrate compliance with safety reporting
timelines, including but not limited to ICSRs, aggregate reports and reporting
to Competent Authority(ies), Ethical Committees and/or Institutional Review
Boards, as applicable
· Maintain electronic and paper file archiving system suitable for
the storage of source documents relating to drug safety.
Requirements:
· BA/BS degree in one of the life sciences and MPH/Epidemiology or
PharmD/MD
· 5+ years of experience in the Pharmaceutical/Biotechnology
industry
· 3+ years of pharmacovigilance experience in drugs/products
· Experience developing and enhancing SOPs, processes and systems
for capturing, handling, resolving and reporting adverse events is highly
desired.
· Excellent communication skills (verbal and writing skills)
· The ability and willingness to travel domestically and
internationally·
· Experience in the design, execution, and analysis of observation
research studies within a pharmaceutical or public health setting
· Experience in research to support drug development
· Experience in research project planning and management
· Experience communicating observational research information
(written and oral)
Would you like to be part of our success in the US? Please forward resume, cover
letter & salary requirements to: Recruitment.US@leo-pharma. (Att: PV-MB).com
An Equal Opportunity Employer
- 3.
-
Medical Science Liaisons - NJ/NY
Posted by: "Abby Kohut" abbykohut@yahoo.com abbykohut
Tue Dec 28, 2010 6:46 pm (PST)
Medical Science Liaisons
LEO Pharma Inc. is a leading global pharmaceutical company specializing in
dermatology and critical care. For 100+ years, our products have improved the
quality of millions of people's lives around the world.
Headquartered in Denmark, we have employees in 50+ countries and our products
are sold in more than 100 countries. To realize our vision of becoming the
world’s leading specialty pharmaceutical company within our focus areas, we are
expanding into new regions and markets, reaching more patients and societies
with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and
creative people who are passionate about what they do, and who are determined to
make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we are recruiting for Medical Science
Liaisons (MSL's) with a successful track record who will be based around the
United States. Candidates will be well versed in Dermatology or Critical Care,
and will have a thorough understanding of the pharmaceutical industry and
current regulatory landscape. The field-based MSL team will function as
Dermatology or Critical Care experts representing LEO Pharma Inc. and will
establish peer-to-peer relationships with key opinion leaders (KOL's) and local
managed care accounts. They will also provide educational and clinical support
services.
Responsibilities:
· Serve as a value-added Scientific and Clinical resource and
extension of LEO Pharma Inc. Medical Affairs and R&D
· Engage with and develop relationships with critical stakeholders
including but not limited to academic and community-based KOLs and investigators
in dermatology or critical care
· Provide educational and technical information answering unsolicited
drug information inquiries
· Establish relationships with Investigators, MCO Medical Directors,
and P&T Committee Members as well as Dermatology Association/Society Members
· Ensure that key stakeholders are appropriately and compliantly
educated on disease state
· Present and or moderate advisory boards
· Create medical slides for review and approval by Director of Medical
Affairs
· Support unsolicited research requests and facilitate discussion
between investigator and R&D
· Identify potential investigators and provide assistance regarding
LEO supported research
· Provide speaker training for speaker bureau speakers
· Engage in competitive intelligence at society meetings
· Engage in sales training as appropriate
· Serve as a field based extension of LEO Pharma and identify
potential acquisition targets
Requirements:
· PharmD, Ph.D., MD, DO strongly preferred
· 1-10+ years of MSL experience
· Thorough understanding of Dermatology or Critical Care and clinical
research
· Ability and willingness to travel ~60% of the time - must live
within 45 minutes of a major US airport
· Teaching and research experience
· Understanding of current pharmaceutical climate and applicable laws
and regulations
· Ability to develop and execute a territory clinical plan
· Ability to work independently
· Excellent interpersonal and communication skills (both written and
verbal)
· Strong presentation skills
Would you like to be part of our success in the US? Please forward resume, cover
letter & salary requirements to: Recruitment.US@leo-pharma. (Att: MSL-YG).com
An Equal Opportunity Employer
- 4a.
-
Director of Compliance - Parsippany, NJ
Posted by: "Abby Kohut" abbykohut@yahoo.com abbykohut
Tue Dec 28, 2010 6:51 pm (PST)
Director of Compliance
LEO Pharma Inc. is a leading global pharmaceutical company specializing in
dermatology and critical care. For 100+ years, our products have improved the
quality of millions of people's lives around the world.
Headquartered in Denmark, we have employees in 50+ countries and our products
are sold in more than 100 countries. To realize our vision of becoming the
world’s leading specialty pharmaceutical company within our focus areas, we are
expanding into new regions and markets, reaching more patients and societies
with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and
creative people who are passionate about what they do, and who are determined to
make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we have an opening for a Director of
Compliance who will be based in our US headquarters in Parsippany, NJ. The
Director of Compliance will be responsible for the development and oversight of
all sales and marketing compliance priorities, both corporate and field based.
The Director will organize all necessary actions to achieve and maintain an
effective compliawnce program, including compliance with federal and state
regulatory requirements, observance of policies and procedures and ensures the
organization-wide communication of its Standards of Conduct.
Responsibilities:
· Manage and oversee compliance activities including developing and
updating a compliance program.
· Promote an awareness and understanding of positive ethical principals
consistent with organizational policies and goals as well as those required by
federal law.
· Communicate compliance activities including written materials and
training programs designed specifically to promote understanding of compliance
issues, laws, regulations, and consequences of non-compliance.
· Implement systems and procedures to capture all information needed to
comply with state and federal reporting requirements.
· Work with inside and outside counsel in connection with compliance
activities.
· Work with appropriate functional areas to implement corrective action
to resolve compliance deficiencies.
· Monitor the performance of the compliance program and relate activities
on a continuing basis, taking appropriate steps to improve effectiveness.
· Maintain awareness of laws and regulations, keeping abreast of current
changes that may affect the organization.
· Direct activities to determine those areas of risk for which compliance
activities should be undertaken.
· Establish and implement periodic monitoring and evaluation programs to
effectively assess compliance of processes that are in place.
· Audit internal corporate procedures.
Requirements:
· Law degree strongly preferred
· 5-7+ years experience in compliance in the pharmaceutical industry
· 3+ years of management experience
· Strong knowledge of compliance regulations
· Strong ability to audit internal corporate procedures
· Strong ability to champion internal policies for both the US Affiliate
and Corporate headquarters in Denmark.
· Strong problem-solving skills
· Ability to communicate effectively both orally and in writing
· Demonstrated leadership ability
· Ability to maintain strict confidentiality
Would you like to be part of our success in the US? Please forward resume,
cover letter & salary requirements to: Recruitment.US@leo-pharma. (Att:com
COD-YG).
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