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*** 3 JOBS LISTED BELOW ***

JOB TITLE: Regulatory Project Manager / Manager of RX - OTC Switch
LOCATION: Parsippany, NJ
COMPANY TYPE: Pharmaceutical Corp.
RELOCATION PACKAGE: Package is available
SALARY: 90K - 110K+
EDUCATION: MS or PhD
TRAVEL: Very minimal
TERRITORY: U.S.
REQUIREMENTS: Our client, a worldwide leader in the Pharmaceutical industry, is seeking a Manager RX-OTC Switch. The qualified candidate will have a PhD and 5 yrs. pharmaceutical experience or an MS with 10 yrs. pharmaceutical experience. You must also have experience in the preparation of Clinical Development Plans and a background in the design and conduct of NDA Phase III trials. You should also have a background in managing CRO's. Regulatory experience is a plus.
RESPONSIBILITIES: Your responsibilities will include in depth clinical/medical evaluation of internal and external switch products, development of labels for target population and preparation of Clinical Development Plans for selected switch opportunities, including Phase I-II dose findings, kinetics and special safety trials. Working with the Marketing department you will also control efficacy trials in target OTC population and collaborate with Consumer/Marketing Research in the planning and design of consumer concepts and studies to validate the commercial potential. You will be a member of the Global RX-OTC Switch Team whose primary focus will be on major US and/or global opportunities.
There is an excellent benefits package offered as well as an outstanding career opportunity. For further information please contact Marci Peister at (983)299-0055 or email resume to marci@tritechnj.com.

 
JOB TITLE: CRA (Clinical Research Associate)
LOCATION: Newtown, PA
COMPANY TYPE: Pharmaceutical Manufacturer
RELOCATION PACKAGE: None
SALARY: 60K - 75K
EDUCATION: BS/BA degree
TRAVEL: Up to 25%
TERRITORY: U.S.
REQUIREMENTS: Our client, a specialty pharmaceutical company focused on the dental and dermatology markets, seeks a CRA with at least 3-5 relevant experience. You must have proven experience in Monitoring Clinical Trials and FDA submissions.
RESPONSIBILITIES: You will assist in implementing clinical studies at the sponsor's location and/or at participating study sites by performing the essential duties. Your responsibilities will include initiating, monitoring and managing Phase I, II, III and IV Clinical Trials. Your duties will also include monitoring, assist in recruiting clinical sites, assist in liaison activities between contracted research organizations, field sites, investigators, study coordinators, pharmacists and staff members. You will also participate in pre-study and site initiation planning, monitor clinical and/or laboratory data to ensure accuracy, thoroughness and regulatory compliance of clinical documentation and ensure resolution of data queries. You will assist in providing technical assistance to study sites regarding the conduct of clinical research, track data forms, reports and documents necessary for completion of clinical study, both in-house and from participating study sites. You will also perform clinical monitoring, site evaluation and closeouts, assure delivery and shipment of drugs and products, maintain and track clinical studies budget and assist in writing FDA submissions. You will act as liaison with professional affairs, regulatory affairs, manufacturing, drug development, research, Quality Assurance and Compliance and accounts payable to facilitate the dissemination of information as appropriate.
For further information please contact Marci Peister at (983)299-0055 or email resume to marci@tritechnj.com.

 
JOB TITLE: HPLC Chemist
LOCATION: Princeton, NJ
COMPANY TYPE: Pharmaceutical R&D Corporation
RELOCATION PACKAGE: None Available
SALARY: 70K
EDUCATION: Ph.D.
TRAVEL: N/A
TERRITORY: N/A
REQUIREMENTS: Our client, an R&D Pharmaceutical Corporation, is looking for an HPLC Chemist. You must have strong HPLC experience in the areas of Bio-Tech or Pharmaceutical industry. The successful candidate will have at least 3 years of industry experience and a Masters degree; Ph.D. preferred. Candidate will also have extensive HPLC experience as well as knowledge of cGMP or GLP protocols This position is bench level.
RESPONSIBILITIES: Your responsibilities will include:
* HPLC Method Development experience
* Small Molecule Analysis (not proteins) in biological fluids, in synthetic/chemical samples, and in drug dosage forms.
* Design and implementation of validation process for HPLC methods. You must also demonstrate excellent verbal and written communication skills. You must be a US Citizen, Green Card holder or a Permanent Resident. Qualified candidates please email resume in Word format to Marci Peister at: marci@tritechnj.com or call Marci at (973)299-0055.