Monday, September 12, 2011

[CNG] Digest Number 2401

Messages In This Digest (9 Messages)

Messages

1.

Earned Value Management System Anslyst - NJ Biotech - From Marty Lat

Posted by: "Marty Latman" baconml@nac.net   martylatman

Sun Sep 11, 2011 12:25 pm (PDT)



Marty,

I am attempting to help a biotech company identify candidates for an Earned Value
Management System Analyst position in NJ. Do you have any suggestions as to
where/how I can find people with this skill?? Job posting is below:

http://www.bio-1stop.org/jobs/node/5797?site=new&rdt=1

Thanks for any insight you can provide!!

Vicki Gaddy, SPHR
908-531-2820
http://www.linkedin.com/in/vgaddy

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2.

Fw: [CIT_Group] Union County Fire Chief's Association 9/11 MemorialT

Posted by: "Brian Mecca" Brian.Mecca@yahoo.com   bd_mecca

Sun Sep 11, 2011 1:32 pm (PDT)





________________________________

From: "Loly Moreno" <eulalia.moreno@verizon.net>
Sender: Careers_In_Transition@yahoogroups.com
Date: Sun, 11 Sep 2011 12:45:03 -0400
To: 'Brian Mecca'<brian.mecca@yahoo.com>; <TheBreakfastClubNJ@yahoogroups.com>; 'AITP'<aitpgardenstatechapter@yahoogroups.com>; <CareerNetworkingGroup@yahoogroups.com>; 'Careers_In_Transition'<Careers_In_Transition@yahoogroups.com>; 'BradcoSupply'<BradcoSupply@yahoogroups.com>; 'NYCE Alumni Association'<NYCEAlumniAssociation@yahoogroups.com>; 'newjerseynetworkers'<newjerseynetworkers@yahoogroups.com>; 'NJ-SENG'<NJ-SENG@yahoogroups.com>; <CareerConnectionsConsortium@yahoogroups.com>
Subject: RE: [CIT_Group] Union County Fire Chief's Association 9/11 Memorial This Weekend
 
To all members,
 
If you can get to the Park, it's a tribute
that should not be missed.  Also, The New York Blood Center is conducting a
blood drive there today.  Please give if you can.
 
Brian, Thank you for your service!
 
Loly Moreno

________________________________

From:Careers_In_Transition@yahoogroups.com [mailto:Careers_In_Transition@yahoogroups.com] On Behalf Of Brian Mecca
Sent: Saturday, September 10, 2011
6:11 PM
To: TheBreakfastClubNJ@yahoogroups.com;
AITP; CareerNetworkingGroup@yahoogroups.com; Careers_In_Transition;
BradcoSupply; NYCE Alumni Association; newjerseynetworkers; NJ-SENG;
CareerConnectionsConsortium@yahoogroups.com
Subject: [CIT_Group] Union County
Fire Chief's Association 9/11 Memorial This Weekend
 
 
For those of you that know me, you are aware that I have been a
volunteer firefighter for over 35 years now.
 
This weekend, the Union County Fire Chief's Association of which I
am a member and the Secretary is holding a very special 10th anniversary commemoration of
9/11 to honor and remember the 343 FDNY firefighters who answered their last
call on September 11, 2011.  There is a link below to picture of the flags
being set up on Friday for this memorial that is described below, one 3'x5'
American flag for each firefighter.  This is a drive by (or stop in)
memorial that will be there until Monday Morning.  It is lit at night, if
you are in the area of Echo Lake Park in Mountainside NJ , please drive through to see this
stunning tribute.  I will be there most of Sunday until about 4:00.
 
 
See
photos - http://www.goleader.com/services/photos/11sep11-firefighters/

Echo Lake Park, Mountainside, New Jersey - The Union County Fire
Chief's Association is hosting a memorial throughout the weekend,
September 10-11, 2011 to honor the 343 New York City firefighters that made the
ultimate sacrifice on September 11, 2001. The memorial displays 343
American Flags (made in America ,
Texas ) 3'x5',
one for each FDNY firefighter who perished.  They are placed across the
grass field in Echo
Lake Park .
The public is invited to drive by and to attend a special ceremony to be
held at 11:30 am on September 11, 2011 at this location. Businesses and
individuals from the region and as far away as Kentucky have made this possible. A
sizeable donation will be made to the St. Barnabus Burn Center in Livingston , NJ .

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3.

AITP Meeting  Tuesday September 13 - DEMYSTIFYING CLOUD COMPUTING -

Posted by: "Brian Mecca" Brian.Mecca@yahoo.com   bd_mecca

Sun Sep 11, 2011 6:11 pm (PDT)



AITP Garden State Chapter presents Mark Galgano - DEMYSTIFYING CLOUD COMPUTING
A complete overview of Cloud Computing.
$10 for first time attendees & Members, includes Presentation, Dinner and Beverage.
Please RSVP to Doug Hobby, Chapter President at Doug_Hobby@hotmail.com
Contact me for more information at Brian.Mecca@Yahoo.com
DEMYSTIFYING CLOUD COMPUTING - Mark Galgano
=======================
A complete overview of cloud computing. Mr. Galgano will cover some of the following related topics:
 
- What is cloud computing? Characteristics, service models, deployment types, pricing, etc.
- Explanation of public, private and hybrid clouds
- Applications best suited for the cloud. 
- Economic benefits.
- Some case studies
- Cloud adoption strategies and concerns.
- Industry trends   
 
THE SPEAKER
=========
Mark Galgano is the Technology Director for Advanced Infrastructure Practice at Turnberry Solutions. He oversees a team of architects, engineers and planners specializing in enterprise infrastructure capabilities including Optimized Desktop, Configuration Management, Virtualization, Messaging and Unified Communications. He provides thought leadership to Turnberry's clients concerning the understanding and leveraging of cloud computing. He is known for his highly creative approaches and entrepreneurial bent. Prior to joining Turnberry, Mr. Galgano held executive IT leadership positions with firms in the IT professional services, investment management, pharmaceutical and market research industries. Most recently he was CTO for Lightspeed Research and COO for Trilogy Capital Management.  He is a graduate of the Un. of Delaware with a BS in Computer & Information Science.
Date: 
Tuesday, September 13
Time: Networking 6:00p, Presentation 7:00p
Cost:  Members and First Time Attendees -- $10
          All Others
------------------------------- $15
Location: Robert Half Offices
             
10 Woodbridge Center, 2nd Floor
              Woodbridge,
NJ 07095
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4.

JOB: Tax Senior - Hackensack, NJ (SAI-HR)

Posted by: "Eric Nilsson" ericnilsson@earthlink.net   norsemantechnology

Sun Sep 11, 2011 8:19 pm (PDT)




TAX SENIOR - HACKENSACK, NJ

Tax Senior - Hackensack

Tracking Code 20110044

Job Description

The audit, tax, and business advisory professionals of this large Public
Accounting firm serve public and private companies across a broad range of
industries, as well as high net worth individuals and closely held
companies. This firm is among the largest 12 accounting firms in the country
and the leading regional firm in the Northeast.

They are currently seeking a Senior Accountant within the Tax Practice in
the Hackensack, NJ office.

The Senior in the Federal Tax practice is responsible for tax return
preparation and review; close interaction with client providing compliance,
consulting and planning; assist in client management and practice
development activities.

o Federal and State Individual, Partnership, Trust and Corporate tax returns
(S-Corp, C-Corp, LLC's) and FAS 109 calculations.

o Coordinate with Client Accounting and Tax departments

o Gather data and reconcile to financial statements

o Develop tax package data requests, instruct staff on tax adjustments and
implementation of tax application systems.

o Review tax returns for accuracy, minimization of tax liability, available
tax credits, and tax provision.

o Respond to client inquires, Internal Revenue Service, State and Local tax
notices.

Required Skills

o BS in Accounting, CPA preferred

o 2-5 years of public accounting experience

o Strong communication skills

o Excel, Word, RIA, CCH, BNA (research, projections), Fast Tax

o Experience preparing and filing Federal and Multi-State Individual,
Partnership, Trust and Corporate tax returns (S-Corp, C-Corp, LLC's)

EOE M/F, D/V Employer

Required Experience

Job Location

Hackensack, NJ, US.

Position Type

Full-Time/Regular
When applying, send resume to: bobhouse44@sai-hr.com, reference SAI-20110044

Retrieved 9/8/2011 from
http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=
<http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=6
9559751&gid=23209&trk=eml-anet_dig-b_jb-ttl-cn&ut=3PpacD9-DyyQU1>
&discussionID=69559751&gid=23209&trk=eml-anet_dig-b_jb-ttl-cn&ut=3PpacD9-Dyy
QU1

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5.

| TCN | Monday, September 26, 7-9pm: Temple Community Network Meetin

Posted by: "TCN Messenger" broman235@gmail.com   broman235

Sun Sep 11, 2011 8:19 pm (PDT)



.
TCN's September 26th meeting will feature an informative presentation by
outplacement leader and innovator Claudia Gentner, entitled:

"HOW TO GET THE MOST FROM YOUR OUTPLACEMENT EXPERIENCE"

Whether you�re in outplacement now, have been in the past, or never were,
the Sept 26th discussion will have value for you. Outplacement firms and
their programs vary enormously in scope and quality and they set the
standard for the conduct of a professional job search. What services do
outplacement firms provide? How can you take advantage of them? How do they
compare to free services offered by community groups and nonprofits?

----------------------------------------

Monday, September 26th, 7:00-9:00 PM
Barnert Temple, 747 Route 208 South, Franklin Lakes, NJ 07417

Directions to Barnert Temple:
http://barnerttemple.org/about_us/about_us.php3?page=249
(Don't trust your GPS on this one, use these directions.)

----------------------------------------

CLAUDIA GENTNER�s career has been in the outplacement industry with a
reputation as a leader and innovator. She was co-founder of Seagate
Associates and CIO of Lee Hecht Harrison. Claudia is now a consultant to
social purpose and mission-driven organizations, focused on solving their
communication and collaboration problems. She also facilitates a Job Search
Work Team in Glen Rock.

----------------------------------------

We look forward to seeing you at Barnert Temple on Monday, September 26th
for our look at outplacement. Please feel free to arrive at 6:30pm for extra
open networking time, and bring a friend! No RSVP's are required.

Next month, we will meet on Monday, October 24th (4th Monday, as usual),
with a guest speaker to be announced.

For more information, contact Bob Roman: broman235@gmail.com or Bob Levin:
blevin@galaxy.net

----------------------------------------
.

Thanks,
Bob
**

*Bob Roman* | Principal, Senior Consultant | Paneverde Design & Technology |
bobroman@paneverde.com | 917.882.5402
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6.

Fw: Full time - Perm Position needs of Manager of CMC Regulatory Aff

Posted by: "Amit Pandey" ammogem@yahoo.com   ammogem

Sun Sep 11, 2011 8:21 pm (PDT)





--- On Fri, 9/9/11, Amit Pandey <apandey@mindlance.com> wrote:

From: Amit Pandey <apandey@mindlance.com>
Subject: Full time - Perm Position needs of Manager of CMC Regulatory Affairs, Principal Associate, CMC Regulatory Affairs & Associate Director of CMC Biologics
To: "ammogem@yahoo.com" <ammogem@yahoo.com>
Date: Friday, 9 September, 2011, 1:56 PM

 
 
Hello,
 
My name is Amit and I'm a recruiter at Mindlance.
 
Mindlance has an urgent contract for one of our direct clients:
 
Position -1
 
Job Title: Manager of CMC Regulatory Affairs
Location: Bridgewater, NJ 08887
Full time - Perm Position
 
Job Description

The Manager, CMC Regulatory Affairs will develop global regulatory CMC strategy and submissions for assigned biologic development projects and/or marketed products in conjunction with appropriate RA CMC management. This includes planning, review, coordination and submission of IMPDs, CTAs, INDs, BLAs, etc.
 
The candidate will proactively provide strategic input and communicate critical topics in a timely manner to interdisciplinary project teams and appropriate management level. Lead cross functional Health Authority response teams for assigned development projects to set objectives for HA meetings, manage interactions and coordinate preparation of HA responses. The candidate must have competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process.  Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables.
 
Primary Responsibilities:
 
1.Will have understanding of regulatory CMC requirements, FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive). 
2.Provides regulatory guidance to ensure development activities are compliant with relevant health authority regulations and in line with current global guidance. 
3.Communicates global regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
4.Represents Regulatory CMC on interdisciplinary teams and technical project teams to outline submission requirements and negotiate timelines for delivery of regulatory CMC submissions. 
5.Assists in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
6.In conjuction with multi-disciplinary teams, prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions. 
7.Reviews and assesses the regulatory impact of change controls/requests for the manufacture, testing and release of development and marketed products. 
8.Assists in the implementation of processes and applications to support regulatory activities
 
Required Skills, Knowledge, & Education:
 
1.Must have 3 – 5 years of pharmaceutical industry experience including a minimum of  2 years of regulatory or related experience. 
2.Demonstrated knowledge of the drug/biologics development process and government regulations/guidelines, including US and international product registration. 
3.Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential. 
4.BA/BS degree or equivalent experience.
 
 
Position -2
 
Job Title: Associate Director of CMC Biologics
Location: Branchburg, NJ 08876
Full time - Perm Position
 
Job Description

The individual will be part of a team that will provide support to the Regulatory Affairs (CMC) Organization. This team's primary responsibility will be to prepare the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of investigational drug applications (INDs, CTAs), initial marketing applications and required amendments. Additional responsibilities include assisting the RA (CMC) group with the compilation of responses to health authority requests. The individual will interact with subject matter experts from various departments and coordinate information exchange during the synthesis of documents. The individual will represent this group on multi-disciplinary project teams. The individual must be detail-oriented and have excellent oral and written communication skills. Must be able to multi-task and adhere to the established project timelines.

Primary Responsibilities:

1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses.
2. Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to prepare regulatory filings.
3. Extract and summarize information from technical documents for incorporation into CMC documents.
4. Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization
5. Offer guidance and feedback during the preparation of project plans for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization.
6. Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met.
7. Develop and supervise direct reports.
8. Work with colleagues towards continual improvement of the work flow process: document creation, document review and document completion.
9. When required, assist with development and maintenance of the department budget.

Required Knowledge, Skills & Education:

1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses.
2. Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to prepare regulatory filings.
3. Extract and summarize information from technical documents for incorporation into CMC documents.
4. Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization
5. Offer guidance and feedback during the preparation of project plans for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization.
6. Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met.
7. Develop and supervise direct reports.
8. Work with colleagues towards continual improvement of the work flow process: document creation, document review and document completion.
9. When required, assist with development and maintenance of the department budget.
 
Position -3
 
Job Title: Principal Associate, CMC Regulatory Affairs
Location: Branchburg, NJ 08876
Full time - Perm Position
 
Job Description

The individual will be a member of a team that will provide support to the Regulatory Affairs (CMC) Organization. This team's primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of investigational drug applications (INDs, CTAs), initial marketing applications and required amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of responses to health authority requests. This position will report to a Director, Associate Director, Manager or equivalent in Manufacturing Technology CMC Regulatory Support. The individual will interact with technical experts from various departments and coordinate information during the synthesis of documents. The individual must be detail-oriented and have good oral and written communication skills. The individual must be able to multi-task and adhere to the established timelines.
 
Primary Responsibilities:
 
1. Responsible for generating, with minimal direct supervision, the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses.
2. Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to implement regulatory filings, with minimal day to day management supervision.
3. As required, coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for the assigned filings.
4. Summarize technical reports and documents to meet the requirements of a given CMC document template section.
5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will require the maintenance of a project plan based on the deliverables established by the product project team and the filing schedule established by the Regulatory (CMC) Affairs organization.
6. As required, participate on multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed.
7. Assist manager with the preparation of an optimized work flow for document creation, review and completion.
8. Assist manager with the development and maintenance of department budget.
 
Required Knowledge, Skills & Education:
 
1. A minimum of 5 years of Biopharmaceutical or Pharmaceutical Industry experience, which should include 1-3 years of authoring regulatory documentation.
2. A working knowledge of US regulatory requirements, with global regulatory experience a plus.
3. A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertise in a technical discipline is a plus.
4. BS//BA degree in a life science, engineering or related field. An advanced degree is a plus.
5. Working knowledge of cGMPs as they apply to the Regulatory environment.
6. Strong organizational and project management skills.
7. Excellent oral and written communication skills, including demonstrated skills in the preparation of regulatory filings.
8. Ability to effectively operate in a cross functional, team based environment.
 
 
           Legal Name:
•         Work authorization Status:
•         Updated copy of your resume:
•         Current Location:
•         Last or recent Salary:
•         Expected Salary :
•         Availability:
 
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 (201) 716-2234, 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.
 
Mindlance is a global Consulting company & Inc 500 | Deloitte Fast 50/500 Award Winner. You may visit our website at www.mindlance.comto learn more about us.
 
 
 
Thanks & Best Regards.
----------------------------------------------------------
Amit Pandey
MindLance, Inc
Phone: (201) 716-2234
E-mail : apandey@mindlance.com
http://www.linkedin.com/in/amitpandey84
 
www.mindlance.com
 
Certified Minority Business Enterprise | Inc 500 | Deloitte Fast 50/500 Award Winner
Hoboken NJ | Metropark NJ | Philadelphia PA | Raleigh NC | Pittsburgh PA | Phoenix AZ | San Diego CA | Gurgaon India | Bangalore India
 
 
..: Mindlance :..
 
Note: We respect your online privacy.  This is not an unsolicited mail. If you are not interested in receiving our e-mails, then please reply with "unsubscribe" in the subject line or click on following link to be removed from our mailing list unsubscribe_ml@mindlance.com.
 
 
 
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7.

Job Search: Why You Should Include Volunteer Work on Your Resume

Posted by: "y jao" yjao88@yahoo.com   yjao88

Sun Sep 11, 2011 8:21 pm (PDT)



Sharing an article circulated by another in-transition network...I hope you find this helpful.

http://m.cio.com/article/689199/Job_Search_Why_You_Should_Include_Volunteer_Work_on_Your_Resume?source=CIONLE_nlt_leader_2011-09-08

Yee
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8.

Webinar: A very special "Double-Header" webinar training session on

Posted by: "Eric Nilsson" ericnilsson@earthlink.net   norsemantechnology

Sun Sep 11, 2011 8:21 pm (PDT)





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Please join us for a very special "Double-Header" webinar training session
on Monday September 12th!

Pay it forward and invite someone you know that could benefit from this
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cCknV-kckG_jD9jObqvntarDRoND6wYhLx5yAz9GFPIiFCvH60J0WPfmLjBPmOLbP1-w==>
Outmaneuvering the Online Application System

As you likely know, if you have been looking for a job for a while, nearly
every job requires that you apply online, either through a company's web
site or through a job posting site, such as Monster.com. Often companies
will enforce a "no phone calls" policy to further keep job candidates from
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CLICK HERE to register for this training session!

Then at 6:30pm CT (7:30pmET, 5:30pmMT, 4:30pmPT) Donna Fedor will present:

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MUKL4P-X_7ipJECm7VECAIjzWAM7gbLjzhuNOUeMPvhUNf8J7fEUByU4_YALt9yeH_lQ==>
Finding Your Passion, Purpose and Power in Career Transition...

One of the great discoveries you make in life is the answer to the question,
"Who am I?" One of the deepest needs of human existence is to know that our
lives count for something; that our gifts and talents are being used to make
a difference. Since work is so much a part of our lives, we want it to be
meaningful.

Are you eager to live the life you deserve yet just don't know where to
start? Do you want to feel passion for life and use it towards your life
purpose?

It's time to stop yearning for an extraordinary life, and start living your
passion, purpose and power. Stop trying to survive your day to day life and
learn to direct your steps with new energy and optimism as you head into the
future "you" get to choose. Being in a career transition is a perfect time
to explore what's possible for you.

Come learn how I found my purpose and how you can find yours. You will get
inspired to powerfully move forward.

* Learn how to be captain of your own ship
* Learn how to instantly build your self-confidence
* Learn the essentials needed shift your emotions empowering you
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9.

Article: What To Do As Soon As You Get Laid Off (Forbes)

Posted by: "Eric Nilsson" ericnilsson@earthlink.net   norsemantechnology

Sun Sep 11, 2011 8:21 pm (PDT)




9/09/2011 @ 11:31AM |1,437 views

Susan Adams <http://blogs.forbes.com/susanadams/> , Forbes Staff

What To Do As Soon As You Get Laid Off

Like just about every media company in the last few years, Forbes has had
plenty staff turnover lately. As the company has let go of some of the old
guard, it has been interesting to watch how each person leaving has handled
his or her exit.

See Susan's recommendations here:

http://www.forbes.com/sites/susanadams/2011/09/09/what-to-do-as-soon-as-you-
get-laid-off/

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