Connecting Radiology | Enabling collaboration and professional development
Job Postings in Healthcare Technology from Andrew Youngelson of Key Recruit - June 2008
This is Andrew Youngelson, Healthcare Technology Recruitment Partner from
Key Recruit, Inc.
I have a job opportunity you might be interested in---see below.
Not interested? I apologize for the inconvenience.
Would you be willing to forward this email to an associate who could benefit
from this opportunity?
Thanks in advance for passing the opportunity along.
Please Indicate by job ID which you are interested in! As always thanks for
passing on!
Director or Senior Director, Regulatory Affairs
Date Posted: 6/18/2008
Job Id: 1628
Company: We are a clinical stage specialty pharmaceutical company.
Our focus is on the treatment and prevention of disorders related to Vitamin
D insufficiency. We have a portfolio of therapeutics with lower development
risk for the indications of Vitamin D deficiency and for secondary
hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our
products address significant unmet medical needs with a target market that
is expected to grow extensively.
Location: Illinois
Reports To: VP Regulatory and Clinical
Salary: 120-160k Commensurate with experience.
Education: BS in biological or chemical sciences; advanced degree is
preferred.
Requirements: 5-10 years pharmaceutical industry regulatory experience
including regulatory submissions to support product approvals and renewals,
and post-marketing strategies and commercial awareness. At least 2 years
people and project management experience with strong interpersonal skills
and proficiency in verbal and presentation capabilities. Ability to work
independently and as a functional leader and participant in teams. Knowledge
of Quality Management Systems would be a plus. Approximately 20% travel.
Summary: The Director or Senior Director, Regulatory Affairs is a tactical
and leadership position that reports to the Vice President of Clinical and
Regulatory Affairs and is responsible for devising and implementing
regulatory strategies for late stage development and post-approval products.
The position responsibilities also include serving as a secondary liaison
with regulatory agencies regarding quality systems and compliance policies
and will be located in the new Chicago office. It is designed not only as a
supervisory position but would be expected to evolve to that position as the
company advances development and commercialization of its leading compounds.
Thus, the ideal candidate would have management and mentoring experience and
would be expected to inspire and motivate, and to serve as a role model for
reports and colleagues.
Duties: Contribute in pro-actively formulating global regulatory strategies
that interpret and reflect regulatory and corporate guidelines Plan, manage
and implement regulatory programs into multidisciplinary project teams for
all products from late-stage development through commercialization.
Represent Company at FDA, DDMAC and other regulatory agencies. Initiate and
respond to regulatory agency contacts (e.g. telephone, email, written,
meetings) to negotiate successfully with regulatory agencies to achieve
business objectives. Responsible and accountable for regulatory review of
promotional materials and for ensuring regulatory compliance of product
brand. Review global product promotional materials and press releases.
Ensure that all documents to be submitted to regulatory agencies are
complete, scientifically accurate, well-organized and of high quality in
such a way as to facilitate review. Assist with the technical transition
from pre-approval research to post-approval commercial phase. Assure
compliance with all agency regulated late-stage development and
post-approval activities including timely and accurate submissions of annual
reports and supplemental filings. Assure that all regulatory and quality
related activities and functions are current, are implemented fully and are
compliant with defined standards, and that company personnel are trained
appropriately. Build and maintain good business and working relationships
with internal and external groups. Communicate to senior management of
regulatory status and risks related to products and compliance. Work with
internal departments and external CROs and CMOs to assure timely and cGXP
compliant disposition of products. Communicate openly and effectively,
working to develop team-based approach and to lead and to motivate
regulatory and compliance activities. Interface directly with regulatory
agencies to host regulatory inspections. Provide guidance on system
validations tasks and product release. Assist senior management to formulate
and to establish company policies and operating procedures (SOPs).
Participate in activities related to potential inlicensing and outlicensing
of products.
=========================
Director or Senior Director, Clinical Affairs
Date Posted: 6/18/2008
Job Id: 1629
Company: We are a clinical stage specialty pharmaceutical company.
Our focus is on the treatment and prevention of disorders related to Vitamin
D insufficiency. We have a portfolio of therapeutics with lower development
risk for the indications of Vitamin D deficiency and for secondary
hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our
products address significant unmet medical needs with a target market that
is expected to grow extensively.
Location: Illinois
Reports To: VP Regulatory and Clinical
Salary: 120-160k Commensurate with experience.
Education: BS in biological or chemical sciences; advanced degree is
preferred.
Requirements: 5-10 years pharmaceutical industry clinical development
experience including support of product approvals and renewals and
postmarketing activities, interacting with principle investigators and key
opinion leaders. In-depth experience with clinical trial methodology, cGCPs
per FDA and ICH guidelines, strategic clinical trial planning and operation,
and comprehensive planning and management of project budgets. At least 2
years people and project management experience with strong interpersonal
skills and proficiency in verbal and presentation capabilities. Ability to
work independently and as a functional leader and participant in teams.
Knowledge of biostatistics and data management would be a plus.
Approximately 20% travel.
Duties: Key Responsibilities: Contribute in proactively formulating
global clinical development strategies that successfully execute Company's
core business of pharmaceutical development. Prepare clinical development
timelines and budgets within multidisciplinary project teams to ensure
timely submissions aligned with Company objectives. Coordinate, facilitate
and construct study designs and protocols, appropriate study monitoring and
conduct within cGCPs and consistent with the requirements for regulatory
filings. Develop, interact with, and manage internal employees and external
CROs and CMOs to assure timely and cGCP compliant activities to achieve
clinical project successes to achieve corporate development plans.
Participate in regulatory submission process, including INDs, CTAs, CTDs,
NDAs and provide appropriate clinical updates to those documents. Ensure
that all documents to be submitted to regulatory agencies are complete,
scientifically accurate, well-organized and of high quality in such a way as
to facilitate review. Serve as the principal spokesperson for clinical
development and communicate to senior management of clinical development
status. Build and maintain good business and working relationships with
internal and external groups. Participate in the selection and maintenance
of study investigators and clinical sites. Participate in analysis and
review of data, and review, edit and contribute to the construction of
clinical documents (study protocols and reports, informed consent and case
report forms, publications) to ensure cGCP compliance and accurate
presentation of data. Communicate openly and effectively, working to develop
team-based approach and to lead and to motivate regulatory and compliance
activities. Assist senior management to formulate and to establish company
policies and operating procedures (SOPs) and ensure that staff attains a
level of quality applicable to the Quality System and applicable
professional standards. Coordinate and implement the requisite training and
development of Clinical Development staff. Provide strategic leadership to
identify potential difficulties and strategic execution to implement
creative approaches to surmount challenges. Participate in activities
related to potential inlicensing and outlicensing of products.
As always thanks for passing on!
Visit www.keyrecruit.com to view other openings.
Andrew Youngelson
Key Recruit Inc.
www.keyrecruit.com
If Interested
Email me your resume as a Word document. And tell me your current salary,
Include a cover letter explaining why you would be a good fit for this
position using the using the keywords in the job requirements as a guide.
To opt out of future mailings and unsubscribe, for fastest results just
simply reply and ask to be removed in body of email not subject. Or if you
would like your email updated to a personal email please submit email
change.
Key Recruit, Inc.
I have a job opportunity you might be interested in---see below.
Not interested? I apologize for the inconvenience.
Would you be willing to forward this email to an associate who could benefit
from this opportunity?
Thanks in advance for passing the opportunity along.
Please Indicate by job ID which you are interested in! As always thanks for
passing on!
Director or Senior Director, Regulatory Affairs
Date Posted: 6/18/2008
Job Id: 1628
Company: We are a clinical stage specialty pharmaceutical company.
Our focus is on the treatment and prevention of disorders related to Vitamin
D insufficiency. We have a portfolio of therapeutics with lower development
risk for the indications of Vitamin D deficiency and for secondary
hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our
products address significant unmet medical needs with a target market that
is expected to grow extensively.
Location: Illinois
Reports To: VP Regulatory and Clinical
Salary: 120-160k Commensurate with experience.
Education: BS in biological or chemical sciences; advanced degree is
preferred.
Requirements: 5-10 years pharmaceutical industry regulatory experience
including regulatory submissions to support product approvals and renewals,
and post-marketing strategies and commercial awareness. At least 2 years
people and project management experience with strong interpersonal skills
and proficiency in verbal and presentation capabilities. Ability to work
independently and as a functional leader and participant in teams. Knowledge
of Quality Management Systems would be a plus. Approximately 20% travel.
Summary: The Director or Senior Director, Regulatory Affairs is a tactical
and leadership position that reports to the Vice President of Clinical and
Regulatory Affairs and is responsible for devising and implementing
regulatory strategies for late stage development and post-approval products.
The position responsibilities also include serving as a secondary liaison
with regulatory agencies regarding quality systems and compliance policies
and will be located in the new Chicago office. It is designed not only as a
supervisory position but would be expected to evolve to that position as the
company advances development and commercialization of its leading compounds.
Thus, the ideal candidate would have management and mentoring experience and
would be expected to inspire and motivate, and to serve as a role model for
reports and colleagues.
Duties: Contribute in pro-actively formulating global regulatory strategies
that interpret and reflect regulatory and corporate guidelines Plan, manage
and implement regulatory programs into multidisciplinary project teams for
all products from late-stage development through commercialization.
Represent Company at FDA, DDMAC and other regulatory agencies. Initiate and
respond to regulatory agency contacts (e.g. telephone, email, written,
meetings) to negotiate successfully with regulatory agencies to achieve
business objectives. Responsible and accountable for regulatory review of
promotional materials and for ensuring regulatory compliance of product
brand. Review global product promotional materials and press releases.
Ensure that all documents to be submitted to regulatory agencies are
complete, scientifically accurate, well-organized and of high quality in
such a way as to facilitate review. Assist with the technical transition
from pre-approval research to post-approval commercial phase. Assure
compliance with all agency regulated late-stage development and
post-approval activities including timely and accurate submissions of annual
reports and supplemental filings. Assure that all regulatory and quality
related activities and functions are current, are implemented fully and are
compliant with defined standards, and that company personnel are trained
appropriately. Build and maintain good business and working relationships
with internal and external groups. Communicate to senior management of
regulatory status and risks related to products and compliance. Work with
internal departments and external CROs and CMOs to assure timely and cGXP
compliant disposition of products. Communicate openly and effectively,
working to develop team-based approach and to lead and to motivate
regulatory and compliance activities. Interface directly with regulatory
agencies to host regulatory inspections. Provide guidance on system
validations tasks and product release. Assist senior management to formulate
and to establish company policies and operating procedures (SOPs).
Participate in activities related to potential inlicensing and outlicensing
of products.
=========================
Director or Senior Director, Clinical Affairs
Date Posted: 6/18/2008
Job Id: 1629
Company: We are a clinical stage specialty pharmaceutical company.
Our focus is on the treatment and prevention of disorders related to Vitamin
D insufficiency. We have a portfolio of therapeutics with lower development
risk for the indications of Vitamin D deficiency and for secondary
hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). Our
products address significant unmet medical needs with a target market that
is expected to grow extensively.
Location: Illinois
Reports To: VP Regulatory and Clinical
Salary: 120-160k Commensurate with experience.
Education: BS in biological or chemical sciences; advanced degree is
preferred.
Requirements: 5-10 years pharmaceutical industry clinical development
experience including support of product approvals and renewals and
postmarketing activities, interacting with principle investigators and key
opinion leaders. In-depth experience with clinical trial methodology, cGCPs
per FDA and ICH guidelines, strategic clinical trial planning and operation,
and comprehensive planning and management of project budgets. At least 2
years people and project management experience with strong interpersonal
skills and proficiency in verbal and presentation capabilities. Ability to
work independently and as a functional leader and participant in teams.
Knowledge of biostatistics and data management would be a plus.
Approximately 20% travel.
Duties: Key Responsibilities: Contribute in proactively formulating
global clinical development strategies that successfully execute Company's
core business of pharmaceutical development. Prepare clinical development
timelines and budgets within multidisciplinary project teams to ensure
timely submissions aligned with Company objectives. Coordinate, facilitate
and construct study designs and protocols, appropriate study monitoring and
conduct within cGCPs and consistent with the requirements for regulatory
filings. Develop, interact with, and manage internal employees and external
CROs and CMOs to assure timely and cGCP compliant activities to achieve
clinical project successes to achieve corporate development plans.
Participate in regulatory submission process, including INDs, CTAs, CTDs,
NDAs and provide appropriate clinical updates to those documents. Ensure
that all documents to be submitted to regulatory agencies are complete,
scientifically accurate, well-organized and of high quality in such a way as
to facilitate review. Serve as the principal spokesperson for clinical
development and communicate to senior management of clinical development
status. Build and maintain good business and working relationships with
internal and external groups. Participate in the selection and maintenance
of study investigators and clinical sites. Participate in analysis and
review of data, and review, edit and contribute to the construction of
clinical documents (study protocols and reports, informed consent and case
report forms, publications) to ensure cGCP compliance and accurate
presentation of data. Communicate openly and effectively, working to develop
team-based approach and to lead and to motivate regulatory and compliance
activities. Assist senior management to formulate and to establish company
policies and operating procedures (SOPs) and ensure that staff attains a
level of quality applicable to the Quality System and applicable
professional standards. Coordinate and implement the requisite training and
development of Clinical Development staff. Provide strategic leadership to
identify potential difficulties and strategic execution to implement
creative approaches to surmount challenges. Participate in activities
related to potential inlicensing and outlicensing of products.
As always thanks for passing on!
Visit www.keyrecruit.com to view other openings.
Andrew Youngelson
Key Recruit Inc.
www.keyrecruit.com
If Interested
Email me your resume as a Word document. And tell me your current salary,
Include a cover letter explaining why you would be a good fit for this
position using the using the keywords in the job requirements as a guide.
To opt out of future mailings and unsubscribe, for fastest results just
simply reply and ask to be removed in body of email not subject. Or if you
would like your email updated to a personal email please submit email
change.
Views: 64
© 2025 Created by radRounds Radiology Network.
Powered by
