Messages In This Digest (3 Messages)
- 1.
- Year End Thanks From: Linda
- 2.
- FW: Project Manager position in NYC From: Tom Bley
- 3.
- Manager, Regulatory Affairs - Parsippany, NJ From: Abby Kohut
Messages
- 1.
-
Year End Thanks
Posted by: "Linda" Linda@BentonSearch.com lindaabenton
Thu Dec 30, 2010 6:19 am (PST)
As we conclude 2010, I want to take a moment to express my sincere gratitude to all my clients. To clients that have provided staffing needs and to candidates that are exploring new career opportunities, thank you for allowing me to establish our business relationship. I look forward to working with each of you in 2011.
Please watch my site www.bentonsearch.com starting mid January and throughout the year, for many new career path opportunities.
I wish you a happy and successful 2011.
Warm regards.
Linda Benton
www.bentonsearch.com
- 2.
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FW: Project Manager position in NYC
Posted by: "Tom Bley" tombley@hotmail.com tom.bley
Thu Dec 30, 2010 6:19 am (PST)
Please contact the recruiter directly Good luck.
Best Wishes,
Tom Bley, PMP
Project / Program Manager
Cell (973) 919-1252
Date: Tue, 28 Dec 2010 18:59:09 -0500
From: kbigini@misicompany.com
To: tombley@hotmail.com
Subject: Project Manager position in NYC
Good Evening,
Our records show that you are an IT professional with experience as a Project Manager. This experience is relevant to one of my current openings.
It is located in New York, NY. The job description is as follows:
Project Manager
NYC
6 months
Please send resumes to Karen Bigini at kbigini@misicompany.com .
SUMMARY:
Our client has a vacancy for Project Manager to assist with the management of several projects. Projects currently underway are the creation of an alternate data center designed to provide balanced processing environments that are able, among other things, to expedite recovery in the event of a disaster. Our client anticipates that a vendor firm will be awarded a contract to execute the data center split. The selected individual will be the Project Manager and liaison with the selected implementation vendor as well as oversights. In addition the project manager will assist with the reviewing, negotiating, drafting, and interpreting purchase agreements. These agreements may cover matters such as: systems implementations; acquisitions of hardware, software, and/or related services arising at a governmental IT agency. All work must be performed in compliance with client and agency policy and procedure.
KEY DUTIES:
Project Manager will also be responsible for directing all aspects of the project including but not limited to the following:
• Scope and Change Management - working with appropriate personnel to set client expectations concerning the scope of each project phase and ensuring that the consultants establish appropriate processes to control change throughout the project lifecycle;
• Client/Sponsor Relationship Management - working with appropriate personnel to develop and maintain open communications and strong working relationships with client agencies as well as key stakeholders;
• Risk Management - identifying and analyzing project risks from the perspective and ensuring that the consultants respond appropriately;
• Quality Management - ensuring that the client establishes appropriate project standards and quality assurance processes so that consultant deliverables and work products meet the needs and rework is prevented or minimized;
• Issue Management & Problem Resolution - working with the client and its consultants to ensure that issues are adequately captured, tracked, and resolved in the client's best interest;
• Performance Management - working with the client and its consultants to set up appropriate status reporting and metrics to monitor and report on project progress and performance;
REQUIRED:
• Minimum 5 years of successful project management experience leading and managing large, complex projects with multiple, competing stakeholder needs.
• Hands-on experience creating/reviewing and negotiating a variety of complex technology contracts, preferably from the customer side,
• Experience in data center management and hardware and software procurement is preferred, as is experience successfully performing in the same or similar capacity
• Excellent drafting and analytical skills
• Excellent written and oral communications skills, and interpersonal skills;
• Strong knowledge of Microsoft Project, Word and Excel; and Visio
• Ability to work with limited supervision, and to manage multiple deadlines in a fast-paced, dynamic environment
EDUCATION:
BA/BS Degree from accredited college/university (required)
.
If you are qualified, 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 (212) 588-8341, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP. Thank you.
Kind regards,
Karen Bigini
MISI Company
45 West 36th Street, 7th Floor
New York, NY 10018
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to MISI. I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.
If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.
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Lookup Candidate
- 3.
-
Manager, Regulatory Affairs - Parsippany, NJ
Posted by: "Abby Kohut" abbykohut@yahoo.com abbykohut
Thu Dec 30, 2010 6:47 pm (PST)
Manager, Regulatory Affairs
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 searching for a Manager,
Regulatory Affairs who will partner with the senior management team and provide
strategic regulatory support. Your goal will be to maintain positive
relationships with customers and regulatory agencies through oral and written
communications regarding pre-submissions strategies, potential regulatory
pathways, compliance test requirements, clarification and follow up of
submissions under review.
Responsibilities:
· Provide input on promotional reviews, research protocols and
reports
· Evaluate and approve proposed changes to products and processes;
develop, approve and implement U.S. regulatory plans based on these changes
· Submit approved material with appropriate documentation to DDMAC
in compliance with submission timelines
· Plan and conduct internal audits, facilitate customer audits and
audits by regulatory agencies
· Make decisions on how data is presented to customers and
agencies
· Provide Regulatory Affairs training to cross functional groups
· Assist with policy and procedure development & implementation in
alignment with corporate headquarters policies.
· Maintain responsibility for processing, investigating, final
decision/disposition of investigation and response to customer complaints
· Assist with agency audits by compiling and reviewing data that
is to be presented to investigator
· Maintain effectiveness of the quality system
Requirements:
· BA/BS degree in one of the life sciences; advanced degree
preferred
· 3+ years of direct regulatory affairs experience in the
Pharmaceutical/Biotechnology industry
· Experience developing and enhancing regulatory related SOPs
· Excellent communication skills (verbal and written)
· The ability and willingness to travel domestically and
internationally as required
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: RA-YG).com
An Equal Opportunity Employer
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