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Our client is a multinational pharmaceutical company that is well-positioned for growth and stability!  We are searching for an Assistant Director, Global Regulatory Affairs CMC to join the team in Exton, PA!  Relocation within the US is available, so please apply today if you possess the required skills. The Assistant Director, Global Regulatory CMC will be responsible for managing and maintaining multiple US and international (including emerging market) registration dossiers which are required due ...

TITLE:                              VALIDATION SPECIALIST LOCATION:                     GREATER PHILADELPHIA, PA AREA CONTRACT LENGTH:    DECEMBER 2013 EDUCATION:                   BS IN ENGINEERING OR SCIENCE DEGREES   JOB DESCRIPTION: Successful candidates will focus mainly on automation, tech transfer, process validation, and laboratory qualification (mainly instrumentation but some equipment).  Activities include review and approval but also assisting in generation of validation deliverables ...

 Hello,   My name is Amanda Tackett and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Information Scientist for a prominent client of ours.  This position is located in Princeton, NJ. Details for the positions are as follows:   Job Description:   ·         Masters degree in library and/or information science or equivalent work experience. Undergraduate degree, required. ·         Taxonomy Development Design of organization, labeling, navigation, and ...

Summary of position: Write and/or review clinical study-related documents (e.g., clinical  protocols and summary reports, clinical study reports, investigator brochures and IB updates, informed consent form, clinical study data listing/table and regulatory agency/IRB submission documents), and managing internal review of study related documentsCollaborating with internal and external team members, investigators and KOLs Participate in safety review team meetings and summarize safety findings ...

Seeking knowledge of clinical studies, translational informatics, and large data set multivariate analysis for oncology bioinformatics of biological systems to support translational medicine initiatives including the discovery and development of biomarkers in order to enhance patient selection and lead choices in clinical trials. Shall: *** Design and execute studies for establishing biomarker profiles. *** Generate hypotheses and guide decisions about biomarkers and targets. *** Contribute ...

 Description Candidate must be dedicated to addressing and solving some of the most important unmet medical needs in cardiovascular and metabolic diseases.   We work to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world. We are nurturing an environment of performance excellence, built on trust, respect and accountability. Through an emphasis on strong leadership and people development, we will accelerate our sales ...

 Description Candidate must be dedicated to addressing and solving some of the most important unmet medical needs in cardiovascular and metabolic diseases.   We work to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world. We are nurturing an environment of performance excellence, built on trust, respect and accountability. Through an emphasis on strong leadership and people development, we will accelerate our sales ...

Contact Devin at 815-756-1221 for more details. Qualifications: - BS/MS Chemistry - Experience formulating surface treatment products - Experience in surface chemistry, surfactant, polymers, etc. - Knowledge of paint application techniques - US Citizen Responsibilities: - Develop, test and improve surface treatment products - Visit customer sites to support product trials and investigate customer problems - Simulate customer processes in the lab to generate test panels - Provide assistance to ...

Contact Larry at 815-756-1221 if you meet the listed qualifications. Qualifications: - BS-PhD in Chemistry, Chemical Engineering, Mechanical Engineering or related - 5+ years of professional experience in lubricant, lubricant additives or related industry - Excellent organizational, communication and teamwork skills - Experience in manufacturing, quality control and technical service desired - US Citizen Responsibilities: - Responsible for the development of commercial and industrial products - ...

 Position Summary   Responsible for leading all safety and risk management of assigned Company products.  It includes appropriate assessment of benefit risk information, medical evaluation of Individual Case Safety Reports (ICSR), evaluation of safety signals, formulation of response to regulatory inquiries on product safety issues and contribution to regulatory documents. Providing leadership in patient safety and pharmacovigilance activities in Global Environment. Contributing to the development of ...

Assistant Director, Clinical Operations- Emerging Markets Location: Exton, PA (Relocation Available) MUST have experience in APAC to be considered! Principal Objective(s):   Work within our multinational pharmaceutical client to oversee the management of Phase I through IV clinical research studies conducted in Emerging Market countries to ensure compliance with regulatory requirements (e.g. GCP/ICH), overall quality study conduct and adherence to study timelines. Major Duties and ...

Sr. Director, Clinical Development Operations Location: Exton, PA (Relocation Available) Our client is a growing multinational pharmaceutical company.  Known for developing and marketing innovative products that improve the lives of patients suffering from serious unmet medical needs, primarily in the inflammatory and viral therapeutic areas. Principal Objective(s):  The Senior Director, Clinical Development Operations is a key role for the strategic planning and implementation of clinical ...

The Medical Advisor provides state of the art medical expertise in the therapeutic area and/or the assigned projects.  In particular, medical expertise is provided to clinical development plans, study outlines, protocols, study reports, investigator brochures, briefing packages, CTDs, draft labels and other documentation required for approval of development products. To be effective in the assigned tasks, the Medical Advisor collaborates with the other internal stake holders (Biostatistics, Clinical ...

Description: The Clinical Supplies Label Operator will, with limited supervision execute assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, Clinical Supplies Label Coordinator, and Inventory Technician such that they deliver quality study supplies that meet both project and regulatory requirements. Principal ...

Description: The Clinical Supplies Floor Supervisor will, with limited supervision, plan for, schedule, and oversee assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, Clinical Supplies Label Coordinator, Inventory Technician, and Clinical Supplies Label Operators such that their team delivers quality study supplies that meet both project and regulatory ...

Description: The Inventory Control and Distribution Technician will, with limited supervision: • Support Clinical Supplies projects in the areas of receiving, distribution, return, and destruction. • Receive product into inventory, coordinating inspection of incoming goods as appropriate. • Collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, and internal customers to achieve on-time delivery of clinical supplies that meet both project and regulatory requirements. ...

CRAs - Join Covance and receive a$5000 Sign On Bonus!     Experienced Clinical Research Associates (CRAs)/Monitors: We are hiring Phase I-IV CRA positions.    Positions are home-based and needed throughout the United States.   All therapeutic areas needed.  Please let us know if your experience includes Diabetes -Type I/II, Oncology, CNS, Inflammatory, Cardiovascular, and Respiratory. Focusing on balance and quality by only working on 1 to 2 studies!   Our Clinical Research Associates ...

We are in need of strong writers for a large CRO on the East Coast! Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms   Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical ...

Clinical Enrollment Manager - Contract - Home Based     The Clinical Enrolment Manager will be responsible for providing on site recruitment and ensuring good working relationships with sites to enhance enrolment opportunities. The core focus will be on the CEM to help improve the recruitment rates. There is a high level of travel required with this position, so potential CEM’s must be willing to travel 4 days a week. Key Accountabilities: - Maintain updated patient database plus regular site contact ...

Our client, a premier Pharmaceutical company, is seeking a Promotional Review Board Medical Editor for a 2 year assignment.  Pay rate is up to $50 an hour plus benefits. Manages the delivery of a full range of editorial services, including medical editing, copy editing, proofreading, and fact verification of pharmaceutical marketing materials, internal and external presentations, and corporate communications, from initial Promotional Review Board (PRB) submission through final approval, including ...

Our client, a premier Pharmaceutical company, is seeking a PRB Proofreader for a 2 year assignment.  Pay rate is up to $32 an hour plus benefits. Proofreads PRB materials post-meeting and post-Editorial initial review. Verifies that all PRB-requested changes were implemented by agency/vendor, including but not limited to checking marketing materials for consistency. Familiar with working in an electronic format and knowledgeable about maintaining and managing this system and inherent workflow in ...

A pharmaceutical client of mine is actively seeking a Senior Formulation Scientist to join their team in the Philadelphia, PA area. This is a full-time permanent position and must be office-based.  Candidates must possess the following experience in order to be considered:Ph.D. in Pharmaceutical Sciences or related field with 4 – 6 years experience in a generic pharmaceutical environment.  Experience in semi-solids is essential. Hands on experience in formulation is a must. Hands on experience in ...

JOB ID: PA21179 Job Title: Forensic Scientist Company: Job Chit Chat Industry/Environment: Biology (a growing company with a family atmosphere) Responsibilities: • Obtain DNA profiles from evidence • Write reports of results • Maintain national DNA database Skills Needed/Experience: • Concentration and attention to detail • Microsoft Office, Excel, PowerPoint, Outlook • Maintain relationships with detectives and officers Location: Philadelphia Salary: $19/Hour DOE Hours: Full Time

Seeking In-depth pharmacokinetics and pharmacodynamics experience and track record driving drug candidates through the development process and more specifically guiding pulmonary therapeutics through regulatory submission, review and post marketing commitments to plan and oversee clinical studies, analyze results, write study reports, develop regulatory documents, interact with regulatory agencies, report progress to partners and investors, and serve as Medical Monitor. Required: *** Extensive ...

Seeking experience developing methods for characterization of protein drug candidates, hands on development experience with Liquid chromatography - Mass Spectrometry, two dimensional Gel Electrophoresis, and track record contributing to BLA and IND filings to lead group of 4 scientists supporting process development and final product comparability evaluations for vaccine developer and manufacturer. World class vaccine development and manufacturing company offering an amazing opportunity to lead a ...

Seeking MD-PhD or MD well rounded research executive with career exposure to Translational Medicine, Clinical Development, Pre-Clinical Development and Discovery to act as key company representative, strategic expert, and savvy diplomat working closely with global pharma CEO in the analysis, selection and internal promotion of drug development strategies from evidence-based medicine to sustainable therapeutic solutions. Must be comfortable working closely with heads of multiple therapeutic areas ...

Responsibilities: This position translates basic written and/or oral packaging descriptions into packaging diagrams and instructions that are used in Clinical Packaging Operation (CPO) specification, batch record and production poster documents. The complexity of Clinical trial packages and the packaging process require an explicit means of communication, such as diagramming or use of photos to precisely define the package structure and facilitate the production process. The individual in this ...

Responsibilities: • The purpose of this role is to support the evaluation of stability data, used to establish shipping qualification statements, by using the appropriate departmental SOPs and Regulatory Guidance’s. • To perform this role the candidate must work cross-functionally and collaborate with QA, R&D, External Manufacturing, Global Transportation, and Shipping Logistics Company. • Candidate will play a critical role in providing thorough review and assessment of data previously ...

Responsibilities: • Support the Shipping Qualification Team in drafting technical documents. • These documents would include, but not limited to Protocols, Standard Operating Procedures (SOPs), shipping qualification statements and reports. • Work cross-functionally and collaborate with QA, R&D, External Manufacturing, Global Transportation, and Shipping Logistics Company • Organize materials and complete the assignment according to set standards regarding order, clarity and conciseness, style ...

Top pharmaceuticals company looking for a Manager of Performance Management and Analytics in Chesterbrook, PA. One year contract with opportunity for extension. Competitive compensation. The Manager, Performance Management and Analytics is responsible for managing all aspects of Performance Management and Analytics for our Technical Operations organization. This position is responsible for combining business process knowledge and data visualization and consumption knowledge to solutions that meet ...

Our client, a premier Pharmaceutical company, is seeking a Medical Editor for approximately 2 years.  The pay rate is up to $47 an hour plus benefits. This position will be on an "as needed" basis. There is no set schedule, nor specific hours. The first two weeks of the assignment will be mandatory onsite training. Manages the delivery of a full range of editorial services, including medical editing, copy editing, proofreading, and fact verification of pharmaceutical marketing materials, internal ...

Must be willing to work any shift: Shift hours will be determined once the person starts working Shift hours are: Day/Evening rotations 8-5 and 3-midnight Day/Night rotator 7-4 and 11p to 8am Eve/Night rotator 3-midnight and 11p to 8am Day shift is also 8 to 5 or 9 to 6.   Requirements / Duties: The Customer Technical Support (CTS) Tier 3 representative will cover the Customer Technical Support queue as assigned by the CTS Supervisor or Manager in order to do the following: • Capture and ...

Responsible for performing study activities regarding the management and verification of medical consistency checks (MCC) and surveillance of titration of patients within clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Ensures clinical investigative site staff adhere to the implementation of the treat-to-target concept to optimize glycemic control without compromising patient safety or data integrity. ...

Experience: Must have Oncology monitoring experience. It is preferred to have protocol and CSR writing experience. 5+ years of pharmaceutical experience in clinical trials.  Must have an understanding of CRO/vendor management, clinical study design, CRF design, project management and familiarity with data handling. Serves as the coordinator for implementation of all clinical trial activities and management of the clinical trial in conjunction with the CRO Oversees/coordinates site visits (pre-study ...

 Please Note: Position located close to Ocean City, Maryland Staff Accountants/Chargeback Analysts --- Manager Opportunity! Newly created position. Salary range @$75 - $80K + Bonus and comprehensive benefits package. Bright future in a great industry! Join the team of a fast-growing, dynamic pharmaceutical manufacturer! Be near the beach and the Bay! Position Summary: Reporting to the CFO, the newly created position will coordinate activities related to Accounts Receivable within the Finance ...

Sr. Manager of Regulatory Affairs opportunity! Great company to work for! Key Requirements: Must have ANDA experience Must have eCTD (electronic data transmissions) experience Must have a Master's degree 8 – 10 years of Regulatory Affairs experience  Please call or email me if you would like more details!

Sr. Manager of Regulatory Affairs opportunity! Great company to work for! Key Requirements: Must have ANDA experience Must have eCTD (electronic data transmissions) experience Must have a Master's degree 8 – 10 years of Regulatory Affairs experience  Please call or email me if you would like more details!

 Proficiency with schematic capture and pcb layout CAD tools • Proficiency in using oscilloscopes, voltmeters, and other electronic tools • Intermediate level skills in analog and digital circuit analysis • Experience with debugging imbedded systems and analog circuits • Good verbal and written communication skills.  • Candidates best suited for this position will typically have obtained a Bachelor's degree and 5+ years of experience in a related field or a suitable combination of experience and ...

Must have written: NDA submissions,  Protocols, Narratives, Case Report Studies, and Inform Consent forms Description: The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other departments and clients to set and meet internal and external deliverable timelines. Write clinical documents for submission to regulatory authorities, including ...

Seeking strategic expert and savvy diplomat to work closely with global pharma CEO in the analysis, selection and internal promotion of drug development strategies from evidence-based medicine to sustainable therapeutic solutions. Shall work closely with heads of multiple therapeutic areas and drug discovery units to drive clinical-to-preclinical backward collaboration in an effort to more effectively select targets and entities at the basic science, pre-clinical, and non-clinical stages. ...

We are working with a cutting edge medical device company that has experienced tremendous growth. Our client is looking for a direct rep in both Philadelphia and in NJ. This is a tremendous opportunity if you have medical device sales exp. in orthopedics or spine. High visibility with a great track into management if you so desire. Managment is a real possibility for the right person as well. All compnay information will be given and details once we connect at. [email removed]  Thanks!

  Key Technical Requirements: • Infomatica - ELR, ETL, CDC, Data Quality • Service Oriented Architecture o Enterprise Service Business (ESB) o Business Process Executive Language (BPEL) o Business Rules Engine (BRE) o Business Activity Monitoring (BAM) o WSDL, XML, XSD • Cloud Intelligence o Veeva o Salesforce o Oracle or Demand • Transformation and Enrichment – Design and develop composite, Business and Data Services • Real Time, Near ...

This is a permanent position. Must have strong experience in Solid Tumor and/or Oncology. Canidates to be located in: NJ, NY, or CT Region to cover: NJ, NY, CT, and PA Job Key Duties and Responsibilities: This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor: Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements,  Standard ...

Contact Larry at 815-756-1221 Qualifications: - PhD Chemist, Chemical Engineer - 10+ years of experience in product development in specialty chemicals - Background knowledge of additives used in the oil and gas industry - Successful new product and technology application development - Familiar with norms, requirements, and practical application testing for oil and gas applications - Basic understanding of additive functionality in oil and gas applications - Excellent communication skills - ...

Seeking: *** Knowledge of animal research procedures and practices. *** Experience with heterografts or xenografts in a molecular biology environment. *** History of successful scientific project administration. *** Ability to effectively manage the logistical aspects of rapid, high volume projects. (project coordination, scheduling, etc.) Shall champion consistently revolving projects focused on grafting of client supplied entities, growth, preparation, and shipping of biological entities ...

Alternate Site Locations:  Groton, CT Collegeville, PA New York, NY Contract Length:  13 Months To work with and on behalf of CTPQ/CQM within DevOps, performing Qualifying Quality Issue (QQI) management. CTPQ = Clinical Trial Process Quality QQI Lead: the individual responsible (from Clinical Quality Mgmt (CQM) or other qualified role) for the formation and leading of the QQI Team and coordinating all activities related to assessing significance, initiating immediate action, conducting RCA, ...

Director, Regulatory Affairs-CMC Location: Horsham, PA (relocation not available) The Director, Regulatory Affairs-CMC is responsible for CMC-related regulatory activities. This person develops and implements regulatory strategies related to CMC throughout drug development from Phase 1 through Phase 4. The Director is also responsible for assessing the regulatory requirements of CMC changes, coordinating and contributing to regulatory submissions and providing guidance to the manufacturing, process ...

A pharmaceutical client of mine is seeking a Sr. Manager, Regulatory Affairs to join their team in the Philadelphia, PA area.  This is a full-time permanent position and must be office-based.  My client is seeking candidates with the following experience: Must be legally eligible to work for any employer in the United States (as sponsorship is not available) Must have ANDA experience Must have eCTD experience Must carry a Master's degree Must have 8 - 10 years of Regulatory Affairs experience ...

Our client, a premier Pharmaceutical company, is seeking a Manager, Project Sourcing for a 6 month assignment.  Pay rate is up to $55 an hour plus benefits. This role will be supporting sourcing project activity within indirect areas, such as management consulting, R&D sourcing, travel sourcing and meetings management. CRITICAL REQUIREMENTS - MUST HAVE 1. Sourcing and procurement experience (indirect, NOT direct) 2. Drafting and sending out RFPs 3. Experience managing stakeholders and their ...

This position is for a Project Manager. Candidates should have 3+ years of experience working as a project manager preferably in the Medical device industry. Candidates must have: a software background. Experience working with Microsoft Project, Word, Excel, and Power Point. Must have good oral and written communication skills. Must be able to work in a colaborative environment. It is preferred that Candidates have previous experience working in an FDA controlled work place.