Responsibilities will include, but are not limited to, the following: Work under the direction of Medical Affairs Statistics Disease Lead. Actively provide statistical support to the Medical Affairs Department. Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R and SAS tools and support for hypothesis -driven as well as exploratory analyses. Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters. Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials. Provide statistical input for design, sample size and protocol for Medical Affairs studies. Provide review of statistical analysis plan including table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO. Manage outside CROs and consultants as needed. Support regulatory responses using Medical affairs interventional and registry data. Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.
Skills/Knowledge Required: •Masters in Statistics with a focus on statistical methods appropriate for clinical trials is essential. Ph.D. in statistics preferred. • Minimum of 3 years of solid experience and demonstrated skill in the planning, analysis and reporting of clinical trials. •Experience with time-to-event data. •Good planning and project management skills. •Knowledge and curiosity of currently acceptable statistical methodologies. •Excellent SAS skills including report generation. Willingness to be hands-on when needed. •Knowledge of MS Office products (Word, Excel, PowerPoint). •Excellent communication, writing and organizational skills is essential. •Demonstrated ability to work in a team environment with clinicians, clinical monitors, data managers, programmers and medical writers.
Senior Research Associate to support drug MOA studies as well as to assist the development of high-throughput in vitro screening assays to support target identification and small molecules discovery for various disease indications within the Biochemistry group.
Responsibilities will include, but are not limited to, the following: • Perform experimental research related to one or more programs • Design research protocols in collaboration with the principal investigator • Maintain an accurate, comprehensible, current laboratory journal • Train others on new skills and procedures • Communicate results in written and oral presentations. Write protocols, procedures and technical reports
Skills/Knowledge Required: Applicants should have completed Bachelor of Science degree in Microbiology, Genetics, Biology, Immunology, Virology or Biochemistry with four or more years of wet lab research experience. Successful candidates will be able to conduct experimental protocols with minimal supervision and analyze and troubleshoot experiments. Candidates should demonstrate strong background in molecular biology techniques (Molecular Cloning, qRT-PCR, transfections, etc), cell and tissue culture, immunoassays, flow cytometry, small-scale protein purification, SDS-PAGE and Immunoblot. Candidates should be proficient in Microsoft Word, Excel, Photoshop, statistical programs and have exceptional organizational skill and ability to accurately document activities. Candidates should have excellent organizational and time management skills and be willing to work occasionally weekend and evening hours. Strong communication skills with the demonstration of emotional intelligence and the ability to work within a matrix organization are essential.
The client is in need of a Developer who will be responsible for the extraction and analysis of data from a large Enterprise Data Warehouse. This person will be responsible for the creation of various data marts and control reports used to monitor the data integrity of client’s business systems. They will also ensure data integrity, reliability and usability in the data warehouse to ensure accurate analysis and intelligent business decisions.
Responsibilities: • Develop a general understanding with respect to the data flow between the various business systems. • Work with internal and external team members to identify potential data anomalies. • Develop control reports to audit and monitor the transactional integrity of client’s Business systems. • Develop dashboards for Sr. Management to monitor critical business functions.
Preferred Skills and Experience: • Bachelor’s degree in Computer Science or related field • Minimum 5+ years of Application Development work experience • Minimum of 5 years of work experience in Data Warehousing environment, experience in handling large volume of data • Solid experience with data modeling and database design for operational as well as analytical systems • 5+ years of experience with data mart design & development on Teradata • 5+ years of experience with Teradata Utilities such as BTEQ, FastLoad, MultiLoad, FastExport, Tpump, etc. • Experience with Informatica a plus • Knowledge of version and revision control practices and procedures • SAS/BASE, SAS Macros, SAS Enterprise Guide, SAS Visual Analytics a plus • Strong knowledge of Excel and Visio. • Strong teamwork skills • Excellent communication skills, both verbal and written • Ability to work well in a team oriented, agile environment • Strong analytical skills and eagerness to learn new technologies
Research Associate in Exploratory Toxicology serves as an integral member of the toxicology team that supports the early stage discovery and development of pharmaceuticals, including the identification, mechanistic investigation and general toxicity evaluation. In general, scientist will provide appropriate technical support to conduct in vivo toxicology studies including formulations, drug dosing, toxicokinetic sampling, prosection, electronic data capture, clinical chemistry, hematology sample analysis.
Responsibilities will include the following: 1. Conduct in vivo studies with contribution to the following technical areas: a. Animal management and study initiation. b. Oral and/or intravenous test article administration. c. Monitoring clinical signs, body weights and food consumption. d. Obtain and process toxicokinetic serum samples. e. Conduct animal post-mortem prosection. g. Conduct clinical chemistry, hematology sample analysis. i. Communicate findings and study outcome to toxicology management.
Communication Skills Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately. Ability to communicate resource needs to management and assist in setting technical work priorities. Ability to work effectively in a collaborative team environment where multiple technical skills are necessary and flexibility in job requirements are dynamic. Computer Skills Familiarity and ease of use with GraphPad Prism, Microsoft Word, Excel, PowerPoint and Outlook.
Responsibilities will include, but are not limited to, the following: 1. Support Global Quality Organization with administration operations, including CelDox (Documentum) projects and assignments, as needed. 2. Assist QA personnel with Migration Spreadsheet (Excel) Mapping for documents and metadata to be migrated from existing systems and share drives into CelDox. 3. Assist QA personnel /Training Manager with tasks associated with CelDox-ComplianceWire integration 4. Typing and routing of SOPs and supporting documents for CelDox system 5. Assist QA personnel with GMP documentation archival duties as needed. 6. Other duties related to the support of Global Quality Organization including training materials and computer applications.
Skills/Knowledge Required: MUST have strong organization skills, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required. Must be able to work with limited day-to-day supervision. Must have a general knowledge of SOP standards. Must have experience with electronic document management systems. A business/administrative school graduate or equivalent in industry experience. Minimum 3 years document management experience. Minimum 3 years experience in the Pharmaceutical industry preferred. Strong PC skills to include: Microsoft Excel and Word Excellent written and oral communication skills.
Under the direction of senior management, responsible for general secretarial, clerical and administrative support duties within corporate. Confidentiality and the ability to handle confidential material is critical to the position. In addition, good interpersonal skills, a team perspective and willingness to work with others are also critical requirements.
Responsibilities will include, but are not limited to, the following: 1. Provide general administrative and clerical support to the department 2. Provide administrative support to SVP, Global Tech Ops for day-to-day operations as well as individual projects as needed. 3. Manage department budget. 4. Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies. 5. Responsible for scheduling, organizing and recording all staff meetings. 6. Organize administrative systems to support department members including filing/records retention and other functions as required. 7. Schedule conference room usage. 8. Manage staff calendars, updating monthly schedule, and arrange travel itinerary and related activities. 9. Prepare presentation materials. 10. Telephone coverage as assigned. 11. Other duties related to the above within client as a whole, as assigned.
Skills/Knowledge Required: Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required. Must be able to work with limited day-to-day supervision. A business/administrative school graduate or equivalent in industry experience. Minimum 5 years administrative assistant experience Strong PC experience and Microsoft Word experience required. Strong Access and PowerPoint skills desirable. Excellent written and oral communication skills
Responsibilities will include, but are not limited to, the following: Manage flow of professional promotional materials through internal cross-functional Copy Review Committee (CRC) – approx 300 jobs/year; ensure adherence to company SOPs
• Build and maintain schedule of review meetings
• Receive and distribute review materials via electronic workflow system (iTRAC) and prepare meeting agendas
• Ensure review committee time is used efficiently (estimate time to complete review of materials; adjust agendas to accommodate reviewer schedule changes; prioritize/reprioritize review items based on business needs)
• Record changes on review materials in live CRC meetings via iTRAC
• Ensure official approval stamps from CRC reviewers are applied in iTRAC
• In partnership with Regulatory, issue “final approval” on promotional materials post-CRC
• Review/proofread printer proofs; consolidate final changes from Regulatory & Product Mgrs
• Ensure delivery of printed samples to Regulatory for OPDP 2253 submission • Facilitate live CRC meetings with the goal of bringing the group to consensus (keep reviewers on subject; manage meeting time constraints; minimize side discussions) • Work with outside advertising agencies on day-to-day operations
• Clarify, review, and reconcile CRC comments into promotional materials
• Ensure accurate preparation of OPDP preclearance submissions • Solicit feedback/provide recommendations for improving CRC effectiveness • Execute special projects as required by Sr. Manager, Marketing Operations Skills/Knowledge Required:
• Highly motivated self-starter with strong project management skills and ability to perform/prioritize tasks in a fast-paced environment with limited supervision
• Strong proofreading skills
• Knowledge of Adobe Acrobat commenting tools
• Knowledge of Zinc MAPS
• Proficiency in Microsoft Office
• BA/BS Degree preferred, preferably in Business Administration or Marketing
Under the direction of supervisors, will be responsible for providing administrative support, as well as general clerical/secretarial support to the team. Ability to act as a team player, strong interpersonal skills, and willingness to multi-task and prioritize are critical requirements.
Responsibilities will include, but are not limited to, the following: • Providing administrative support to supervisors. Including: Managing schedules, meetings, travel arrangements, and expense reports. • Offering general secretarial/clerical support to supervisors. Including: opening and sorting mail, faxing documents, making copies and maintaining supplies. • Implementing/organizing/maintaining files, records, and databases. • Updating invoice tracking for supervisors. • Telephone coverage, as assigned. • Providing shared support to department Managers. Including: opening and sorting mail, faxing documents, making copies and maintaining supplies. Skills/Knowledge Required: • Advanced PC Skills area a must.
Includes: MS Outlook, Word, PowerPoint, and Excel. • Ability to work independently, while acting as a team player, as certain responsibilities will be shared. • Willingness to work in a fast paced environment where individual initiative and accountability to the team are required. • Strong interpersonal skills • Ability to multi-task and prioritize. • Excellent written and oral communication skills.
Responsible for managing the completion of projects. Oversees all aspects of projects. Sets deadlines, assigns responsibilities, manages financials, and monitors and summarizes progress of project. Prepares reports for upper management regarding status of project. Requires a PMP certification and 10 to 12 years of experience managing IT Project in the Pharmaceutical environment. Familiar with a variety of the field’s concepts, practices, and procedures such as SDLC, 21 CRF Part 11. Relies on limited experience and judgment to plan and accomplish goals. Leads and directs the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
These are the requirements: 1. PMP Certified by PMI 2. IT Project Management for 10 to 12 years 3. Knowledge of all or most of the following: • LIMS, • Electronic Lab Notebooks (ELN), • Scientific Data Management, • Chromatography Data Systems, • Virtual Screening, • Compound (Inventory, Request, Assay Request), and • ActivityBase.
Summary: • Assist the Scientific Software Development team with software implementation, testing, and application support. • Assist with troubleshooting, capture and documentation of problems, and propose potential solutions to the software development team. • Provide basic support to users. • Be adaptive to the use of new software aids and programming techniques as they are acquired or adopted within the software development group.
Skills/Knowledge Requirements: • Candidate must have or is working towards a Bachelor of Science degree in Computer Science (with some science coursework preferred) or other scientific discipline (such as Biology or Chemistry) with equivalent programming experience. • Demonstrated experience of interacting with end users and the ability to be extremely customer focused in providing support. • Requires strong communication skills, ability to work well in a small team environment, and ability to multi-task. • Must be meticulous and detail oriented. • Knowledge of basic Java programming skill and familiarity with web applications. • Experience with scripting in any scripting language. • Prior work experience in biotech/pharmaceutical R&D environment is a big plus. • Familiar with IT system analysis, project life cycle, and SDLC processes a plus.