In Brief:
You will be carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), Statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Strong technical skills and Oncology experiences supporting submissions are required.
Duties:
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (Client), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. SDTM and ADaM technical knowledge required. In addition, knowledge of agency requirements including ICH, FDA, and other guidances is strongly recommended. Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs.
3. Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers.
4. Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.
Required:
Minimum of Bachelors degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters strongly preferred. Strong educational background is expected.
Minimum 8 years experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is expected.
Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment. Understanding of submission-related activities and experience with agency-related requirements expected. Define.XML knowledge and familiarity with a submission process is preferred.
Oncology and in-depth ADaM programming required. Submission support with compliance is expected.
Skills:
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
Knowledge of SDTM and ADaM standards.
Proven experience with UNIX and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues. Proactive and effective working. Accountable. Leadership expected.
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
Source: Job Diva – Job Listing
POSITION SUMMARY: Responsible for conducting research and development laboratory experimentation and other scientific activities to support projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GLP, Design Control, Design of Experiments and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments. ESSENTIAL FUNCTIONS: – Executes laboratory experiments; makes detailed observations and analyzes data. – Prepares technical reports, summaries and quantitative analyses. – Maintains complete and accurate records. – Normally receives detailed directions on all work. – Makes suggestions to improve work processes. – Assists in reducing to practice patentable inventions. – Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors. – Exercises judgment within defined procedures and practices to determine appropriate action. – May participate in cross functional technical team activities. – Presents and discusses data within group. – Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills and Abilities: – Knows basic and some specialized laboratory techniques. – Familiar with searching scientific literature. – Skilled with use of word processing, spreadsheets, graphical and presentation software applications.
Source: Job Diva – Job Listing
The candidate will be a member of the Viral Technology Flu support lab team and will be responsible for assisting with the execution of experiments within the process development laboratory. The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures. Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision. Key responsibilities will include: Perform technical process operations for developmental lots. Execute process unit operations including: tangential flow filtration, centrifugation (continuous and batch), virus inoculation and propagation, and sterile filtration. In order to support process development operations, candidate will also be required to support various lab functions such as: Solution and buffer preparation. Equipment cleaning, assembly, and sterilization. Sampling, sample login, transfer, and logging of results. General lab duties such as general housekeeping and cleaning and inventory management. Identify production issues and relays them to the laboratory management. Ensure all required paperwork is complete, accurate and done in a timely manner to ensure a quality product. Participation in cross-functional teams, where necessary, to assure correct performance of process operations and working with management to resolve process operations issues. Follow all procedures put into effect to ensure your safety as well as the safety of others. Participate in safety meetings, report all safety issues, concerns, incidents and near misses to the team leadership. Follow good documentation practices to record all activities performed and data generated in production of developmental experiments. The primary shift will be standard business hours, however, experiment schedule will also require overtime and off shift work.Skills: Demonstrated interpersonal skill, including flexibility and ability to work in a team environment. Experience with biopharmaceuticals, vaccines process development, or laboratory scale execution of tangential flow filtration, centrifugation (batch and continuous), cell culture. Demonstrated written and verbal communication skills. Demonstrated organization skills, ability to multitask, and work in a dynamic environment. MS Office 2010 or higher.Education: Two years of university in a scientific discipline plus experience in Vaccine, Biologic, or Pharmaceutical manufacturing or development or Bachelors Degree/Undergraduate Degree in scientific discipline plus experience in Vaccine, Biologic, or Pharmaceutical manufacturing or development. Preferred BS/BA Chemistry or Life Science.. Years of Experience: 3 – 6 Years
Source: Job Diva – Job Listing
Do not submit candidates that was submitted to Request 11868337. Manager has already reviewed and or interview candidates.
The Quality Engineer partners with multiple stakeholders across the organization, internally and externally to ensure the production of quality products. Responsibilities include collaborating with internal and external stakeholders when issues occur, including root cause analysis and process improvement conducted both internally and at the supplier; provide performance feedback through communication and auditing.
Job Duties:
Collaborates with cross functional team of Manufacturing Engineers, Quality Engineers, Buyer/Planners, Production and Procurement Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
Provides technical guidance and quality compliance for Supplier Quality engagement on products, subassemblies and parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and *** requirements
Collaborates with engineering laboratory and production functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
Audits quality systems for development acceptance criteria (parameters based on product result).
May undertake root cause analysis of incidents requiring corrective action. Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
May be certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement.
Minimum Requirements:
Bachelors Degree
The ability to fluently read, write, understand and communicate in English
3-7 Years experience
Experience with Quality Management System
Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);Familiarity with medical device complaint files and quality records;nowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
Strong computer skills (including Excel)
Source: Job Diva – Job Listing
Skills
Basic Requirements
Source: Job Diva – Job Listing
Product Safety Data Coordinator and Coding Associate:
This position is within Clients Product Safety Group.
Description of Responsibilities:
Code and enter information into the Product Safety database for Adverse Events
reported in association with Clients Marketed and investigational products. The
individual will be responsible for verifying the accuracy and completeness of
information for each adverse event report for which he/she is assigned in
conjunction with the source documents and ensuring that the activities are
performed in a manner consistent with Clients SOPs.
Requirements:
Health Care Professional (with or without previous drug safety experience) or non-health
Care Professional with previous drug safety experience desired
2-3 years minimum experience in medical coding/terminology within a
pharmaceutical organization.
Computer proficiency required, including data entry of adverse event information
into standardized electronic databases such as ARISg/ARGUS
*Strong written and verbal communications are essential
Strong attention to detail and accuracy are essential
Strong proofreading, editing and reviewing skills are essential
Must be able to work independently, and possess problem solving skills, but also
know when to seek assistance from manager.
Bachelor’s Degree Required.
Source: Job Diva – Job Listing
JOB FUNCTIONS/RESPONSIBILITIES:
QUALIFICATIONS/EXPERIENCE REQUIRED:
Source: Job Diva – Job Listing
To support release product that meets required quality and manufactured standards to affiliates and the public.
Major Accountabilities Perform routine analysis of raw materials, finished goods, products, packaging components, complaints, investigations per schedule and per standards/SOPs Collect and analyze critical utility and/or environmental samples Collect, calculate, and interpret test results Enter and report test results
no previous experience required. This is an entry level role
Source: Job Diva – Job Listing
Job overview
This position is responsible for performing routine tasks, operating equipment, and troubleshooting in the area of automated Syringe Inspection and Syringe Packaging. This position supports execution of the production plan.
Responsibilities
Operate and troubleshoot high-speed automated Inspection and Packaging equipment. Typical tasks include loading syringes onto automated inspection equipment, changing label reels, replenishing/packaging items (e.g. inserts, labels, cartons, lidding rolls, base film rolls, shippers), operating syringe assembly machine, thermoformer, cartoner, case palletizer, serialization equipment, and wrapping pallets.
Participate in line changeovers and continuously strive to minimize line downtime and maximize OEE%.
Ensure compliance with cGMPs and SOPs at all times.
Perform routine Quality and Safety inspection walk-throughs of the production areas.
Perform scheduled cleanings of equipment and packaging rooms.
Will serve as witness of routine unit operation tasks for batch record/signing. Maintains all associated documentation for operations being performed.
May assist with formal CAPAs and NCRs as needed.
Adheres to the production schedule and provides overtime and weekend support when needed.
Performs routine assignments with supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
Other duties may be assigned as required.
Skills
________________________________________
Preferred Qualifications:
Prior mechanical experience and/or experience working as a Packaging Operator in Pharmaceutical or Medical device industries.
Engineering background
Experience working with automated Inspection and/or Packaging equipment.
Syringe/Vial Experience
Experience working in a manufacturing position in a GMP environment.
Production line experience in Pharma or Medical Device
Terms of employment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, majority of the work activities are performed while standing.
Ability to stand over intervals of several hours at a time
Ability to bend, squat, and reach
Ability to lift, push or pull various amounts of weight
Ability to pass the required visual acuity test (wearing corrective lenses if needed)
Based on production demands and personnel availability, different start time scenarios or additional hours may be required so a flexible work schedule is required for the candidate. Core Work hours for the available shift is as follows:
Mid Shift: Mon-Fri: 9:00 AM to – 5:30 PM
Occasional Weekend Overtime is required.
Education
________________________________________
HS Diploma or GED and 3-5 yrs experience
AA degree in science, engineering or a related discipline and 1-3 years experience
BS degree in science, engineering, or a related discipline and 0-3 years experience
Source: Job Diva – Job Listing
We are seeking a qualified research associate to join our team that focuses on protein characterization using mass spectrometry-based technologies in gene therapy/cell therapy. The successful candidate will design and carry out experiments, perform analyses and interpret analytical data to characterize proteins.
Description:
Responsible for the execution and analysis of experiments and analytical procedures.
Display an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures.
Investigate basic technical problems and performs routine scientific procedures and experiments under general supervision.
Plan and prioritize concurrent experimental procedures.
Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results.
May provide oral presentations on results to other department members.
Work under active supervision.
Follow established procedures.
Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.
Contribute to the completion of milestones associated with specific projects.
Failure to achieve results or erroneous execution may cause delays in program schedules and may result in the allocation of additional resources.
Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
Years of Experience: 2+ Years
Education: BS or MS in Chemistry, Biochemistry, Biology or related life science fields
Qualifications:
The candidate must have excellent analytical laboratory instrumentation and protein analytics skills.
A practical experience in sample preparation and HPLC analysis are required.
Hands on experience in operating and maintaining mass spectrometers and biophysics techniques such as DLS are highly desirable.
The candidate should be self-motivated, well organized, attending to detail, and a good oral and written communicator.
The candidate must be able to work well in a team environment and have good problem-solving skills.
Source: Job Diva – Job Listing
Regulatory Affairs Associate II
Support the drafting of technical documentation, global core files, and HA submission section content across dossiers for priority projects within the *** Digital Health and Connected Medical Device portfolio
Support drafting of software medical device regulatory procedures
Source: Job Diva – Job Listing
* DATA SCIENTIST / ANALYST
* RESOURCE WILL COMBINE MULTIPLE DATA SETS ACROSS A VARIETY OF PLATFORMS TO MAKE RECOMMENDATIONS ABOUT THEIR CUSTOMER EXPERIENCE
* SQL
* EXTENSIVE PYTHON FOR IT IS THE PLATFORM THEY’LL BE USING
* ADVANCED EXCEL EXPERIENCE
* ANY EXPERIENCE WITH QUALTRICS WOULD BE PREFERRED; MICROSOFT DYNAMICS (PREFERRED)
* ADVANCED, 8+ YEARS OF EXPERIENCE
* MACHINE LEARNING/AI EXPERIENCE
* PREDICTIVE ANALYTICS EXPERIENCE
* FOR FRAMING – BEEN ON PATH FOR HIRING THIS PERSON FOR A WHILE, NEEDED FOR A WHILE – LEADING CANDIDATE IN A FULL TIME CAPACITY
* CONTINGENCY AND SUPPORT PLAN FOR THAT PERSON
* SO IT WILL BE A TEAM OF TWO, UNDERSTUDY TO SENIOR
* CONTRACT TO HIRE – NEED TO GROW THE CX SKILL WITHIN THE ORGANIZATIONS
* IDEALLY CARMEL, BUT OPEN TO OTHER LOCATIONS – WITH THEM HAVING MULTIPLE SITES, COULD HAVE
* REMAIN OPEN TO REMOTE CANDIDATES
* WHEN SCREENING CANDIDATES – POSTED A SIMILAR JOB IN JUNE / JULY – MOST CANDIDATES RECEIVED WERE PROJECT MANAGERS – NO PMS PLEASE!
* OTHER ITEMS TO WATCH FOR – CANDIDATES IN ADVANCED LEADERSHIP ROLE – THAT’S NOT SOMETHING THEY’RE REALLY LOOKING FOR – THIS PERSON IS GOING TO MORE HANDS ON
Source: Job Diva – Job Listing
ROLE CAN BE EITHER IN EAST HANOVER, NJ OR FORT WORTH, TX
ASSOCIATE CLINICAL DEVELOPMENT DIRECTOR: 3 YEARS OF INVOLVEMENT IN CLINICAL RESEARCH OR DRUG DEVELOPMENT IN AN ACADEMIC OR INDUSTRY ENVIRONMENT SPANNING CLINICAL ACTIVITIES IN PHASES I THROUGH IV. 2 YEARS OF CONTRIBUTION TO AND ACCOMPLISHMENT IN ALL ASPECTS OF CONDUCTING CLINICAL TRIALS (E.G., PLANNING, EXECUTING, REPORTING AND PUBLISHING) IN A GLOBAL/MATRIX ENVIRONMENT IN PHARMACEUTICAL INDUSTRY
CLINICAL DEVELOPMENT DIRECTOR EXPERIENCE: 7 YEARS OF INVOLVEMENT IN CLINICAL RESEARCH OR DRUG DEVELOPMENT IN AN ACADEMIC OR INDUSTRY ENVIRONMENT SPANNING CLINICAL ACTIVITIES IN PHASES I THROUGH IV. 3-5 YEARS OF CONTRIBUTION TO AND ACCOMPLISHMENT IN ALL ASPECTS OF CONDUCTING CLINICAL TRIALS (E.G., PLANNING, EXECUTING, REPORTING AND PUBLISHING) IN A GLOBAL/MATRIX ENVIRONMENT IN PHARMACEUTICAL INDUSTRY
DUTIES:
THE ASSOCIATE CLINICAL DEVELOPMENT DIRECTOR (ASSOC. CDD) IS RESPONSIBLE FOR THE SCIENTIFIC AND CLINICAL STRATEGY OF ASSIGNED CLINICAL TRIALS, SCIENTIFIC MONITORING, AND REPORTING OF QUALITY DATA. MAY BE RESPONSIBLE FOR THE CLINICAL AND SCIENTIFIC STRATEGY OF ASSIGNED SECTIONS OF A CLINICAL DEVELOPMENT PROGRAM, DEPENDING ON THE SIZE AND COMPLEXITY
MAJOR ACTIVITIES :
1) PROVIDES CLINICAL LEADERSHIP, MEDICAL AND SCIENTIFIC STRATEGIC INPUT, AND CONTRIBUTES TO DEVELOPMENT OF TRIAL RELATED DOCUMENTS (E.G., CTPS, INFORMED CONSENT FORM, CASE REPORT FORMS, DATA MONITORING COMMITTEE CHARTERS, DATA ANALYSIS PLAN, REPORTS, PUBLICATIONS) FOR ASSIGNED CLINICAL TRIAL(S) CONSISTENT WITH INTEGRATED DEVELOPMENT PLAN (IDP); DEVELOPS MATERIALS FOR TRIAL-RELATED ADVISORY BOARDS, DATA MONITORING COMMITTEES, INVESTIGATOR MEETINGS, AND PROTOCOL TRAINING MEETINGS FOR COMPANY LOCAL MEDICAL ORGANIZATIONS
2) PROVIDES CLINICAL AND SCIENTIFIC INPUT AND CONTRIBUTES TO CLINICAL SECTIONS OF TRIAL AND PROGRAM LEVEL REGULATORY DOCUMENTS (E.G., INVESTIGATOR’S BROCHURES, HEALTH AUTHORITY BRIEFING BOOKS, SAFETY UPDATES, SUBMISSION DOSSIERS, AND RESPONSES TO HEALTH AUTHORITIES)
3) IN COLLABORATION WITH APPROPRIATE CLINICAL TRIAL TEAM (CTT) MEMBERS:
A) ENSURES CLINICAL SUPPORT OF TRIALS AS NEEDED
B) CONDUCTS ONGOING MEDICAL AND SCIENTIFIC REVIEW OF CLINICAL TRIAL DATA WITH CLINICAL SCIENTIFIC EXPERT(S) WITH APPROPRIATE OVERSIGHT FROM MEDICAL LEAD
C) MANAGES PATIENT SAFETY REPORTS ON TRIAL DATA TO SAFETY AND CLINICAL BOARDS (E.G., SAFETY MANAGEMENT TEAM (SMT), GCT, GPT) WITH APPROPRIATE OVERSIGHT FROM MEDICAL LEAD
D) PROVIDES INPUT INTO FINAL ANALYSES AND INTERPRETATION INCLUDING THE DEVELOPMENT OF THE CLINICAL STUDY REPORT(S) (CSRS), PUBLICATIONS AND INTERNAL/EXTERNAL PRESENTATIONS
4) SUPPORTS THERAPEUTIC AREA HEAD (TAH) WITH CONTRIBUTING TO PEER-REVIEW OF IDPS, CTPS, AND OTHER CLINICAL DOCUMENTS ACROSS VARIOUS INDICATIONS AND PROGRAMS
5) SUPPORTS DEVELOPMENT OF TA STRATEGIES, AS NEEDED
6) MAY CONTRIBUTE TO THE MEDICAL AND SCIENTIFIC EVALUATION FOR BUSINESS DEVELOPMENT & LICENSING (BD&L) OPPORTUNITIES
7) CONTRIBUTES TO TALENT AND CAREER DEVELOPMENT OF CD ASSOCIATES THROUGH ON-BOARDING, COACHING, AND/OR MENTORING SUPPORT; DEVELOPS AND FOSTERS CD CULTURE; AND MAY CONTRIBUTE TO THE PERFORMANCE EVALUATION OF CTT MEMBERS
8) CONTRIBUTES TO MEDICAL/SCIENTIFIC TRAINING OF RELEVANT COMPANY STAKEHOLDERS ON THE DISEASE AREA AND COMPOUND/MOLECULE. MAY SERVE AS SPEAKER FOR FRANCHISE MEDICAL/SCIENTIFIC TRAINING
9) CONTRIBUTES TO GLOBAL INITIATIVES (E.G., PROCESS IMPROVEMENT, TRAINING, SOP DEVELOPMENT, OTHER CLINICAL DEVELOPMENT LINE FUNCTION INITIATIVES)
SKILLS:
· WORKING KNOWLEDGE OF THE ASSIGNED DISEASE AREA IS DESIRED WITH PROVEN ABILITY TO INTERPRET, DISCUSS AND PRESENT EFFICACY AND SAFETY DATA RELATING TO CLINICAL TRIAL(S) OR PROGRAM LEVEL
· DEMONSTRATED ABILITY TO ESTABLISH EFFECTIVE WORKING RELATIONSHIP WITH KEY INVESTIGATORS
· WORKING KNOWLEDGE OF GCP, CLINICAL TRIAL DESIGN, STATISTICS, AND REGULATORY AND CLINICAL DEVELOPMENT PROCESSES
· STRONG COMMUNICATION SKILLS, WRITTEN AND ORAL
· STRONG INTERPERSONAL SKILLS
· STRONG NEGOTIATION AND CONFLICT RESOLUTION SKILLS
EDUCATION:
ADVANCED DEGREE IN LIFE SCIENCES/ HEALTHCARE (OR CLINICALLY RELEVANT DEGREE) IS REQUIRED. PHARMD, OR PHD STRONGLY PREFERRED
Source: Job Diva – Job Listing
Summary:
Author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. Support technical operations with Controlled Changes.
Duties:
Deviation and Investigation Management:
Corrective and Preventative Actions:
Change Requests:
Communication and Process Improvements:
Site Quality and Compliance
Minimum Requirements:
Source: Job Diva – Job Listing
Performs microtomy and may perform other histotechniques such as grossing, processing tissue, embedding, and/or cryotomy, H&E staining, coverslipping, IHC and ISH using platforms under the guidance of senior Histotech team members.
Maintains lab records and equipment.
Participates in 6S activities
Supports instrument ad equipment maintenance and provides suggestions to improve work processes and laboratory equipment.
Skilled in microtomy (quality and speed).
At least one year experience (intern or employment) in a histology lab performing histotechniques is preferred.
Read, analyze, and interpret Operating Procedures, instructions, technical procedures.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Computer Skills: Proficient at Microsoft Office, and use of email.
Source: Job Diva – Job Listing
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