Position: Director, Legal Affairs Department: Legal Status: Full-time Reports to: CFO KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. The Director, Legal Affairs will be responsible for (i) ensuring that KindredBio contracts meet legal standards and client requirements, (ii) advising the business regarding legal, regulatory, and internal policy compliance obligations in the contracting process and obligations undertaken by KindredBio in legal agreements, and (iii) maintai...

As a FISH - Laboratory Supervisor, you will have the overall responsibility for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and personnel in the department. You will be responsible for performing duties to meet quality assurance, safety and accreditation requirements in the laboratory. The FISH - Laboratory Supervisor is also responsible for helping in the implementation of all area procedures and operations as well as ensuring that metrics established to measure quality, production and effici...

Our client, a growing pharmaceutical company, is looking for a Director/Senior Director of Regulatory Affairs to join their terrific team! Job Description: Reporting to the VP, Regulatory, the Director/Senior Director, Regulatory Affairs will be responsible for developing and implementing Regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. This individual will provide Regulatory leadership and a sense of urgency to cross-functional teams responsible for glob...

Will support formulation development work by developing, troubleshooting, and validating suitable analytical (LC, GC) test methods quickly and efficiently. Examples include assay and related subs methods for actives, fast LC methods for DDU and APSD, and GC and LC methods for excipients. Will perform hands-on lab work as well as direct, develop and train analytical scientists. Will provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry, manufacturing and controls (CMC). In addition, will trans...

Senior Regulatory Specialist is responsible for coordinating the registrations of products in US and/or international markets. Description Plan, compile, prepare, and submit applications (510(k), PMA, Technical Documentation, etc.) to register new, and re-register existing, company products with foreign regulatory agencies. Communicate with FDA and other regulatory bodies regarding submissions. Review and approve changes for design, manufacturing and labeling changes to ensure compliance with FDA and international government regulations. Own de...

Manufacturing Execution System Manager This position is responsible for managing the MES department and the implementation and of a new, companywide MES software. The implementation of the system includes strategic planning, system validation, regulatory compliance and multi-departmental collaboration throughout the process of creating Electronic Batch Records (EBR) to replace paper batch records of laboratory activities in a diagnostic environment. Laboratories including, but not limited to the following: Buffer Preparation, Antibody Purification, E...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Clinical Site Manager • Experience Level 5 years Clinical Research experience (as centralized in-house monitor or onsite monitoring ideal) within multi therapeutic areas – particularly strong oncology or more complex diseases/trials (transplant, sepsis, HIV, etc.) • Degree requirements 1. Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy 2. Bachelor’s degree from an accredited university or equivalent. • Relevant Experience: 1. Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site mana...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monit...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the mon...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

Our client, a growing pharmaceutical company located in Mass., is currently growing their team! We are currently looking for the company's new VP Clinical Research and Development. Responsibilities include, but are not limited to: Under the direction of the Chief Medical Officer, the Clinical Lead will be responsible for building and executing on the clinical development plan for late stage product pipeline including, design, implementation, monitoring, analysis, and reporting of clinical studies. This person will also collaborat...

Our client, a growing pharmaceutical company, is currently hiring and growing the team! This position, the Senior Director, Global Safety Officer/Physician/Medical Monitor, is responsible for: • Management and oversite of a Pharmacovigilance vendor • Single point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments • Performs Medical Review of adverse event reports including but not limited to all serious, events of interest, and expedited indivi...

DOCS is currently seeking an experienced pharmaceutical industry professional for a Clinical Trial Senior Business Planning Analyst opportunity that will be office-based in the Boston area. Responsibilities: · Develop & present key metrics, conduct benchmarking analysis and financial reporting for GCO · Implement and maintain monthly reporting processes and planning support for all of GCO, including all clinical trials – covering global as well as regional trials · Identify trends, advise management and recommend...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

Opportunity to work in the clinical trial agreements and contracts area for a leading global pharmaceutical company. JOB DESCRIPTION: Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grant...

Opportunity to do pricing and budgets for clinical trials for one pharmaceutical sponsor. JOB DESCRIPTION: • Responsible for the development and analysis of clinical site reimbursement for Phase 0-4 protocols across all therapeutic areas. Provide support to the clinical team in the development and analysis of global per patient and site budgets to ensure consistency in development and adherence to healthcare compliance, legal, organizational and other applicable guidelines. • Responsible for the development of fair market value for investigato...

Opportunity to do pricing and budgets for clinical trials for one pharmaceutical sponsor. JOB DESCRIPTION: • Responsible for the development and analysis of clinical site reimbursement for Phase 0-4 protocols across all therapeutic areas. Provide support to the clinical team in the development and analysis of global per patient and site budgets to ensure consistency in development and adherence to healthcare compliance, legal, organizational and other applicable guidelines. • Responsible for the development of fair market value for investigato...

**Reply with your resume and which locations below you are interested in?** Cleveland, OH Medical Technologist - Blood Bank - 19-00697 - 2 Shifts available: o 3pm to 11:30pm o 11pm to 7:30am Macon, GA Medical Technologist - Blood Bank - 19-00634 - 2 Shifts available: o 7 on/7 off - 9p- 7a o 3p-11p Technical Specialist – Blood Bank - 19-00633 - Day shift Stamford, CT • MUST HAVE OR BE ELIGIBLE FOR ASCP! Medical Technologist - 19-00627 - FT Core Lab (Chem) - DAY SHIFT - FT Night and Evening Shift Generalist Medical Technologi...

Responsibilities and Accountabilities • Demonstrates innovative design, development, and execution of process development projects through literature review and scientific teamwork. • Assess and interpret experimental data using DOE and statistical techniques. • Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors. • Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing and sup...

Responsibilities: • Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage • Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials • Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific...

***Pay rate is very competitive, overseeing about 6 staff, IR Neuro and Cath Lab procedures…must be a working manager. Call required, but will be salaried, so call will not be paid to them. it is part of the job. They must be able to cover anywhere from 7a-6p, 8 hrs shifts…but be responsible for anyone that isn’t at work, etc….again working mgr. As for pay, anywhere from 70-105K depending on exp. Working at our Tradition Hospital, newest facility. Great docs, environment and awesome staff.*** I. Basic Purpose: Manages the Intervention...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis...

Description: Candidate will be responsible for actively developing new pharma and biotech business to drive new revenue growth in the U.S. Responsibilities include but not limited to acquiring new business and developing relationships through individual’s pre-existing contacts, and may possibly include taking over existing client work. Candidate must be technically independent much of the time, be well experienced in compiling and writing RFP proposals, working in depth with internal core teams and clients for successful technical transfers, have a s...

Flow Cytometry JOB openings in FL, NJ and IL. ASCP preferred

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clini...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior experience with large ...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

Position Summary Work in conjunction with the Director who has the ultimate authority and responsibility for the specific genetics' division. Help provide direction and leadership for the administrative, fiscal, technical and scientific responsibilities of the division. Help ensure the safe and efficient operation of the division's clinical diagnostic service. Help provide consultative services at an institutional level to departments, divisions, committees, and cancer center (scientific staff within Medical Center and BRI) scientists, as well as to ...

DOCS is hiring! Are you looking for a company that values their employees and promotes work/life balance? If so, we are looking for Senior Clinical Research Associates/Senior Site Managers. A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Pract...

Responsibilities: • Develop and implement overall marketing and sales strategy, subject to approval by the owners • Focus on medical device markets o One-stop shop approach: company provides all services needed for your medical device:  Regulatory Affairs  Quality systems  Concept development/ideation  Product development – engineering through qualification, fully compliant with national and international regulations  Product approval – regulatory agencies in US, Canada, EU, other  Product safety qualification – Nationally Recognized T...

remote, contract biostatistician, one year renewable contract with leading pharmaceutical company Top 3 Must Have Skill Sets: • Software Development Life Cycle experience • Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS • Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies Day to Day Responsibilities: Within the first 30 days a ...

This position will work closely with the Head of Biometrics in identifying project demands and resource needs. This role will be responsible for leading the Biometrics team, which includes programming and data management, to provide strategic, scientific and statistical leadership to the assigned clinical development program(s), with guidance from the Head of Biometrics. This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory and quality requirements are met and that plans are aligned with development goals. T...

Senior Statistical Programmer 6 month renewable contract Key Responsibilities Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic...

1 year renewable contract - Onsite NJ Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when nece...

- 9 month potentially renewable contract - Onsite NJ CORE JOB FUNCTIONS: • Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data. • Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research. • Actively provide statistical support to the Medical Affairs Department. • This position coul...

- 1 year renewable remote contract The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external...

- 12 month potentially renewable contract - Ideally onsite NJ but will consider remote Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the qua...

- 12 month potentially renewable contract - Onsite Seattle Responsibilities will include, but are not limited to, the following: 1. Actively provide statistical support to the Clinical R&D Department. • Provide statistical input into the design of protocols including preparation of the statistical analysis section. • Prepare statistical analysis plans including table/listing/figure shells. Provide derivation for key variables and review data/programming specs. • Analyze and report results of clinical trials. Provide tables, listings and gr...

- Onsite San Diego - 6 month initial contract length CDISC Experience required NDA submission, ISS and ISE , big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all programming activ...

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Montreal Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through ...

Duties & Responsibilities: • Follow Sponsor’s training, instructions, and reference documents for accurate filing of trial documents into Sponsor’s TMF • Manage the workload for assigned trials (approx. 5-7) • Work with the Clinical Trial Manager and trial team to identify and maintain the country and site specific List of Expected Records (LoER) • Perform quality checks on filed documents according to current standards and instructions • Track filing activities and quality checking results using Sponsor’s provided tools and instructions • Sche...

The chosen candidate will: • Be a strong negotiator, able to identify cost savings through vendor cost reduction and consolidation • Provides daily leadership and supervision to procurement and planning • Be responsible for ensuring continued flow of materials and supplies using min/max, build to forecast and build to order principles. • Ensures that buyers and planners are following best business practices and is compliant with all Company policies. • Develops action plans and task assignments to improve supplier responsiveness, performan...

I am reaching out to you to inform you, your friends, or colleagues of an Clinical Geneticist job opportunity available in Westchester County New York. *ABMG required and NYSCoQ* If any interest, please forward your CV or Resume to me via e-mail at: jfoster@stafficons.com or please send me the referrals contact info or please pass this message on to them. See brief job description below: MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medic...

DOCS is hiring! Are you looking for a company that values their employees and promotes work/life balance? If so, we are looking for Senior Clinical Research Associates/Senior Site Managers. A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Pract...