|
Contract QA associate (NJ)-six
month assignment
Reviewing batch records for GMP
compliance under the direction of the QA Manager,
identifying errors and missing information in
the batch record and arranging meetings with
production personnel to correct the errors and
obtaining review signatures, identifying deviations
and reporting them to the QA Manager and Compliance
department, testing report forms for in-process,
release and product stability, reviewing documents
for accuracy, GMP compliance and validity, comparing
results to current specifications to assure
product quality and assisting in additional
tasks as required.
BS in life sciences preferred.
Must be computer literate in MS windows based
applications. Must be able to speak, read and
write English to understand and comply with
written procedures, instructions, SOPs and other
documents. Accurate record keeping, documenting
and organizational skills are a must. Candidate
must be able to perform in a fast paced environment
and have excellent communication skills.
apply
for this job now
or
email us your resume
(include the title and location of the job)
Contract QA associate (NJ)-six
month assignment
Perform incoming inspections of
all GMP controlled raw materials, sampling and
submission of samples for testing as needed,
prepare purchase orders as related to submissions
to contract facilities, labeling of GMP raw
materials, adhere to FDA/cGMP regulations as
well as SOPs, assist in the processing/reviewing
of all incoming Raw Material Specifications
related documentation and assist with additional
tasks as needed.
BS in life sciences preferred.
Must be computer literate in MS windows based
applications. Must be able to speak, read and
write English to understand and comply with
written procedures, instructions, SOPs and other
documents. Accurate record keeping, documenting
and organizational skills are a must. Candidate
must be able to perform in a fast paced environment
and have excellent communication skills.
apply
for this job now
or
email us your resume
(include the title and location of the job)
VP, Regulatory
(MA)
Direct activities of the Regulatory Affairs
department including Regulatory Project Liaison,
Regulatory Operations, Regulatory Surveillance/Information,
maintenance of the corporate regulatory archive
and IND/NDA submission activities. Develops
and manages capital and operating budgets for
the Regulatory Affairs Department. Interacts
directly with government agencies, including
FDA Review Divisions. Organizes and manages
meetings with senior FDA Review Division personnel
to obtain commitments and agreements enabling
rapid and compliant development drug programs.
Provides regulatory strategy input to senior
management in cross-functional development groups.
apply
for this job now
or
email us your resume
(include the title and location of the job)
Senior
Director, RA (MA)
The Sr./Director of Regulatory Affairs prepares
and submits NDA supplements, annual reports,
advertising and promotional materials, and other
filings to FDA that are required for NDA compliance,
for marketed products. Interacts with regulatory
agencies to facilitate approval for product,
manufacturing, and labeling changes. Provides
comprehensive regulatory support for company
products. Manages all regulatory activities
for ex-U.S. marketing applications, including
strategy development, preparation and submission
of Marketing Authorization Applications, preparation
and submission of Mutual Recognition Applications,
and periodic reports. Provides guidance on international
pharmaceutical regulations. Assesses strategic
options for proposed commercial product changes
and commercial product line extensions and advises
Senior Management on recommendations for development.
Reviews and approves advertising and promotional
materials, and provides guidance in the development
of compliant sales training, advertising and
detail literature. Advises Sales and Marketing
staff on regulatory issues and impacts of promotional
activities. Reviews and approves presentations
and materials to be used by medical liaisons
and other scientific staff. Advises Medical
Liaison and Medical Communications groups regarding
regulatory issues and impacts of these activities.
Coordinates these activities with R&D submission
and labeling development strategies and with
FDA labeling negotiations. Manages post-market
surveillance requirements for commercial products
by assessing regulatory categorization of adverse
events reported and preparing/filing expedited
safety and periodic safety reports to FDA Group.
apply
for this job now
or
email us your resume
(include the title and location of the job)
Director, Regulatory Affairs
(MA)
Responsible for regulatory aspects of External
communications including Ad/Prom activities for
all products in the company including management
of a staff or regulatory professionals.
Responsible for leading group charged with
reviewing external communications materials,
sales and marketing, training and communication
strategies for compliance to current regulations
and guidance. Will represent the regulatory
department with corporate senior management and
provide advice on regulatory issues specific to
external communications that affect the business
of the company. Represents the company to
outside customers and agencies and makes
presentations on current regulatory issues
pertaining to Advertising and Promotional
activities.
Will work closely with senior personnel in
Marketing, Corporate Communications and Legal to
support commercial interests and registration
activities of business. Will participate in
training of sales and marketing personnel on
promotional, marketing, labeling and advertising
regulations. Provides strategy and risk
assessment analysis to business units with
regard to external communications. Responsible
for developing long- and short-term planning and
supervision of regulatory projects which impact
the company's business plan. Candidate will be
responsible for taking lead in developing
processes and procedures relevant to the
creation, review and approval of advertising and
promotional materials and other external
communication with references to regulatory
compliance. 5-10 years regulatory experience
including knowledge and experience with
promotional labeling and advertising
regulations. Must be proven leader with
management experience. BS or higher.
apply
for this job now
or
email us your resume
(include the title and location of the job)
Associate
Director, RA (NY)
Reporting to Director of RA , develops and executes
RA plans for biologics programs; Organizes,
reviews and prepares/files INDs. Maintains INDs
in current state. Organizes pre-IND meetings
and FDA communications; Participates in Project
Teams. Interfaces with R&D, QA, QC/AD, and Mfg
to identify CMC requirements; Interfaces with
Pre-Clinical and Medical Affairs groups to identify
safety and clinical trial requirements; Keeps
abreast of biologics CMC requirements for antibodies,
vaccines and gene therapy, and clinical development
requirements for cancer and HIV biologics; Keeps
abreast of clinical strategies employed by other
companies for similar indications/programs;
Interfaces with the QA and RA Compliance groups
to assure GMP and GCP compliance for all biologics
programs. Requirements: Requires a MS or PhD.
In Biology, Chemistry or Pharmacology with 5-10
yrs experience in biologics/biotech in R&D,
Medical Affairs or QA/QC/Manufacturing, with
3-5+ years experience in biologics RA.
apply
for this job now
or
email us your resume
(include the title and location of the job)
Group Director,
RA (MA)
Direct and manage the activities of RA Directors
responsible for worldwide development projects.
Develop corporate regulatory strategies and
specific regulatory development plans for new
product development. Implement strategies for
rapid critical path development and approval
of marketing application, including planning
and strategy for IND development Ph 1-3, preparation
and submission of new INDs, management of regulatory
support activities for nonclinical development,
support of clinical development , e.g. protocol
reviews, development of product description
template, draft product labeling, review of
study reports, technical sections of NDA/CTD
etc. Management of development and preparation
of marketing applications (NDA and CTD electronic
formats). Provide guidance and advice to senior
management to achieve goals for regulatory timelines,
strategy, nonclinical and clinical testing,
development of product marketing promotional
platforms and materials. Requirements: Minimum
BS degree in life or physical science. Advanced
degree (MS,PhD) preferred, not required, RPh/
PharmD desirable. Minimum of ten years direct
regulatory affairs experience within the pharmaceutical
industry.
apply
for this job now
or
email us your resume
(include the title and location of the job)
QA Manager
(NY)
Conduct various types of audits including clinical
investigator site, sponsor, vendor, submission/document,
and internal systems/processes; plan and carry
out audits; prepare timely QA reports documenting
audit results; interact with various teams to
ensure corrective actions and bring QA observations
to closure; maintain audit database information,
ensuring accuracy and completeness; provide
oversight for audits delegated to external consultants
or other third parties; maintain working knowledge
of SOPs and relevant regulations/guidelines;
provide GCP guidance and training to customers,
clinical investigators, etc.; interact with
multiple functional groups to support the development
and implementation of process improvements and
effective QC processes; participate in the development
and implementation of procedures to promote
standardization within the QA group. 3 years
in clinical research or regulatory affairs with
at least 2 years auditing experience (GCP preferred).
apply
for this job now
or
email us your resume
(include the title and location of the job)
QA/QC Specialist
(CA)
Actual position offered commensurate with experience
and skills. Following standard operating procedures,
performs routine release, stability, and in-process
testing of materials, samples, or final product
to ensure quality in order to support the release
of materials for production or products for
commercial or clinical use. Documents test results
in order to meet regulator requirements. Compiles
and enters data into computer databases to be
used for tracking and trending purposes. Under
general supervision, performs routine and non-
routine tasks, which support the review and
release of raw materials, intermediates, or
finished products following established test
methods. Review test results to ensure results
meet specifications. Generally consults with
senior staff regarding results, which deviate
from established standards for direction. Under
direction, may perform validation of new equipment
to ensure equipment is in working order. Recognizes
routine problems with equipment or individual
assays. Troubleshoots or investigates routine
problems with senior staff. May be involved
in developing and improving assays for better
efficiency results. May revise standard operating
procedures for new processes and existing systems
for consistency and compliance with regulatory
requirements if management approval is received.
May train analysts to complete job tasks effectively
and efficiently. Performs other duties as assigned.
Requirements: Typically requires a Bachelors
degree in a scientific discipline or equivalent.
Minimum of 2 years of related experience, or
0 - 2 years of related experience with a Masters
degree in a scientific discipline or equivalent.
apply
for this job now
or
email us your resume
(include the title and location of the job)
|
