Job Summary:
The Medical Information Specialist is responsible for meeting the medical information needs of external customers and internal business partners as it relates to the company’s products. He/she will contribute to the development of high-quality Medical Information deliverables within the team and will be a visible member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to:
• Utilize clinical and scientific expertise to respond to medical information inquiries from health care professionals, patient/consumers, field staff, internal business partners and other customers
• Monitor scientific literature for potential adverse event reports; report findings to Product Safety within established timeframes
• Research and conduct detailed analyses of the scientific literature for Client marketed products, investigational compounds, competitor products/compounds, and related disease states. Contribute to communication, reporting and storage of findings
• Contribute to the development and revision of standard medical responses, AMCP dossiers, Q & A documents and other medical information resources
• Ensure medical accuracy of Client’s advertising, promotional and scientific materials as part of Copy Review Committee and Product Medical Review Committee, in collaboration with Medical Information Managers and Medical Directors
• Assist with and contribute to other Scientific Communications and Medical Affairs activities
Essential Functions include:
• Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners, regarding Client marketed products, investigational compounds, clinical trials and other product information 50%
• Utilize literature evaluation skills to monitor scientific literature for potential adverse event reports; Research and conduct detailed analyses of the scientific literature for Client marketed products, investigational compounds, competitor products/compounds, and related disease states for use by Scientific Communications, Medical Affairs and other internal business partners. Contribute to communication, reporting and storage of literature findings 10%
• Contribute to the development and revision of standard medical responses, AMCP dossiers, Q & A documents, and other medical information resources 20%
• Support the Medical Information Managers and Medical Directors with CRC and PMRC processes by reviewing advertising, promotional and scientific materials for medical accuracy 10%
• Assist with and contribute to other Scientific Communications and Medical Affairs activities, training and performance improvement initiatives 10%
Scope Measures
The Medical Information Specialist provides clinical and technical expertise necessary for the completion of departmental programs and projects. The Specialist is required to have frequent contact with cross-functional departments and external customers and is a key contributor in the completion of programs and projects. Errors made by the Specialist may result in program delays, expenditure of resources and in the case of literature monitoring for potential adverse events, failure to meet regulatory requirements. The Specialist’s activities are done under some direction from the Medical Information Managers and/or Associate Director.
Knowledge/Skills/Abilities Required:
• Biomedical training and education (RPh, RN – PharmD preferred).
• Superior literature database search skills
• Excellent written and verbal communication skills with experience in medical writing
• Superior customer service skills
• Knowledge of U.S. regulatory standards related to pharmaceutical manufacturers’ communications and dissemination of medical information, clinical trial processes and drug approval processes.
• Minimum of 1 year of experience in pharmaceutical industry-based medical information or related discipline
• Familiarity with Microsoft Office software and customer management software
Source: Job Diva – Job Listing
Candidate Requirements:
Source: Job Diva – Job Listing
Assists Analytical & Process Science on authoring developmental protocols and reports, as necessary.
Creation and revision of GMP documentation including Production Batch Records, Standard Operating Procedures, and related documentation.
Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely production start dates.
Driving the continual improvement of GMP Batch Records and SOPs between review cycle by soliciting and incorporating feedback from Analytical & Process Science, Engineering, and Quality groups.
Review of completed batch records and other GMP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations.
Coordinates and develops with Analytical & Process Science, Engineering and QA Teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities.
Coordinates the activities of other Technical Writers to deliver on the overall plan
Acts as project leader. Prepares and maintains the plan for preparation of all required documentation (SOPs etc.) to support the overall project plans
Coordinates the activities for documentation preparation with all stakeholders.
Supports preparing Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification documents/programs.
Ensures that all activities are in compliance with cGMP, Health Authority regulations and the *** Policies.
Knowledge of biopharmaceutical unit operations for production of cell therapies is preferred.
Qualification experience or applicable experience in a related area in the Pharmaceutical industry.
10+ years of Pharmaceutical industry experience and 5+ years of Facilities, Utilities, Equipment and Analytical Instruments.
Experience from Quality Assurance and Project Management preferred.
5+ years of experience in a GMP environment or relevant GMP documentation experience.
Proficiency in standard word processing software and project management software is required.
Mandatory professional skills including knowledge of cGMPs for biopharmaceuticals, organized and disciplined record keeping, excellent communication skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet tight deadlines.
Leadership skills
Source: Job Diva – Job Listing
The Solution Architect will:
• Reach technology solution design options and technology choices through written recommendations that elaborate rationale through analysis & collaboration
• Develop solution roadmaps, target state solution architectures, document design approaches with the delivery of specifications and working prototypes
• Advance the state of application portfolio towards cloud-readiness through expert-level insights and advocacy
• Contribute exemplars of executed patterns and technology to Architecture Reference Library
If you have a passion for modernizing technology and practice in a challenging and dynamic domain, this is the job for you!
We are looking for:
• Bachelor's degree in Computer Science, Software Engineering or related field
• 10+ years' software engineering and architecture experience with modern technologies
Source: Job Diva – Job Listing
Security Architect is responsible for creating security architecture for business solutions of the company that ensures reliability of the energy grid for 45 million people. You share a passion for security, risk, compliance, and securing systems in an environment that fosters cloud architectures, agile processes, and modernizing technologies. The ideal candidate enjoys driving standardization, security best-practices, evaluations, and problem-solving through collaborating with other teams and thrives working in a dynamic environment!
As our Security Architect, you will:
• Collaborate with business and technology stakeholders to conceptualize to-be architecture designs that achieve desired trade-offs across technology strategy, business goals, and security outcomes
• Create security architecture strategies and roadmaps
• Develop and maintain security architectures in alignment to the Reference Architectures
• Understand security threat vectors of various solution architectures
• Lend insights to the practices, technologies, and procedures for security best practices and security architectures
We are looking for:
• Bachelor's Degree with 5+ years of security experience, and 3+ years of Security Architecture experience
• Deep knowledge of Security Frameworks (NIST 800-53, ISO 27002, COBIT)
• Familiarity with Cloud Security Frameworks (i.e. FedRAMP, Cloud Control Matrix)
• Risk modeling methods (CIA, FIPS 199)
• Solid understanding of application threats and their mitigations
• Extensive knowledge on security assessment methods and techniques
Source: Job Diva – Job Listing
Essential Functions
1. Medical Review of Individual Safety Case Reports
2. Participates in the training of the Safety Specialists and Coordinators
3. Administration, Education and miscellaneous
Job Description
• Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events
• Assesses the relationship between drugs and adverse events
• Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review
• Participates in the training of the Safety Specialist and Coordinators
• Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely Medical Review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities
• Responsible for the Causality Assessment for both, developmental and marketed product safety for Individual Case Safety Reports
Knowledge/Skills/Abilities Required
• Health care professional degree required – MD, PharmD or Bachelor’s Degree in Nursing
• 3+ years previous experience in medical review
• Knowledge of disease pathology and physiology, pharmacology and therapeutics
• Knowledge of International and US Regulatory Requirements
• Previous experience using a Pharmacovigilance Database
• Experience with quality assurance activities; attention to detail
Source: Job Diva – Job Listing
We are seeking a highly skilled Project Manager with experience in applying project management within a structured phase gate driven Product Development Process for the development and continuous enhancement of Roche Tissue Diagnostics medical device enterprise software products.
This position will work in close partnership with the Project Leader to establish and monitor project plans and budgets, integrate functional plans into the master project schedule, establish and monitor project risks registers, develop communication plans and guide project teams to deliver on project deliverables and objectives in accordance with corporate product development and quality systems processes. The Project Manager will utilize project and document management software-based tools, templates and framework to maintain and update key project information for reporting and status. The Project Manager will apply Agile SCRUM methodology and exercise strong leadership and interpersonal skills to foster and build positive team dynamics and motivate the team to deliver its goals and objectives, on time and within budget and will work to resolve and manage project risks and conflicts. This position will involve collaboration across technical functions and geographically dispersed development teams to steer projects through corporate product development processes.
The Project Manager serves as the single point of control for project data (collect from functions/finance; owns version management and release of changes); and compiles and communicates project reports.
Skills
Knowledge, Skills, and Abilities:
Must Haves
Education
Formal Training/Education:
Minimum (required):
BS/BA in science, engineering, or business administration
OR
equivalent combination of education and work experience
Preferred:
Master’s degree
Life Sciences field of study
Specific Project Management training and/or certification
Experience:
Minimum (required):
5 years project management and/or product development experience;
Preferred:
Experience in research & development
Experience in regulated industry
Experience of challenging management in relation to data and resources.
Previous experience with standard project management process (PMI) desired.
Source: Job Diva – Job Listing
Description:
We are looking for Senior CPU Performance Engineer. The candidate will take part in definition and implementation of client’s next generation high-end microprocessor. The individual shall be responsible or contribute to the various phase of the development work.
Responsibilities – depending on the actual assignment and skill set, the candidate will focus on all or part of the technical areas below:
Requirements:
Source: Job Diva – Job Listing
Analytical scientist with experience in LC-MS analysis to assist with developing and implementing critical assays to support R&D activities. The scientist will be responsible for sample preparation, data acquisition and data analysis. Activities will include medium-throughput screening for drug discovery and quantification of biomarkers in complex biological matrices. Activities may also include characterization and quantification of chemicals.
Ability to carry out protocols following instructions. Ability to assist in experimental design is a plus.
Expertise with analytical instrumentation. Experience with HPLC, High Resolution Mass Spectrometry and LC-MS/MS methodology including quantitation using triple quadrupole mass analyzer is preferred; the knowledge of GLP environment is a plus.
Maintenance and troubleshooting multiplexing and micro-chromatography systems.
Experience with sample preparation for LC-MS analysis.
Effective communication skills.
Willingness to learn new skills and assist on a variety of projects.
Source: Job Diva – Job Listing
Duties:
Design and execute method development for small molecule drug substances and drug products
Execute Novartis protocols for analytical method validation
Execute routine and non-routine analytical testing using a variety of modern techniques such as HPLC, GC, LC/MS, FTIR, and XRPD
Use modern software and LIMS systems
Compile, analyze, and present data
Author technical documents
Assist with OOE and/or OOS observations
Participate in project team meetings as required
Education and Required skills:
Chemistry degree (BS, MS, Ph.D.)
Experience in a regulatedPharmaceutical (GxP) laboratory environment
Expertise in small molecule characterization
Experience with solution, suspension, and emulsion dosage forms
Significant experience with analytical method development and validation in accordance with ICH guidelines
Mass spectrometry experience and thorough understanding of organic chemistry is a plus
Source: Job Diva – Job Listing
Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision.
Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contributes 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.
Experience: 3 to 6 years
This role will involve applying first-principle chemical engineering concepts such as mass transfer, fluid transfer, scaling to develop scale down stress models. Hands on experience in biologics process development and working knowledge of processing unit operations are desirable but not a requirement. Comfortable with both modeling and experimental assignments.
Preferred Qualifications:
Hands on experience in biologics formulation development and scale-up/down process development
Solid understanding of processing unit operations such as freeze-thaw, mixing, filtration, filling etc.
In depth knowledge in drug product process development including process simulation, scale down model development, process characterizations, and process scale up
Demonstrated scientific and technology expertise to develop diverse dosage forms and associated process technologies for high-concentration protein formulations
Experienced in liquid and lyophilization process development
Source: Job Diva – Job Listing
This is a Laboratory Information Management Systems Administrator. This position will provide Master Data set-up, user support, and training. Additionally, this position will provide support for validation of system enhancements. This will include processing change controls, requirements gathering, and writing and execution of test scripts.
Essential Duties and Responsibilities:
Coordinate the set-up and revision of Master Data to meet site timelines, provide support to users on an as-needed basis, troubleshoot issues reported by end-users, train new users, and provide validation support for system enhancements.
Requirements:
• Prior experience with LabVantage LIMS software is preferred.
• A minimum of 4 years documented experience in LIMS administration.
• Excellent technical, communication, and writing skills.
• Ability to work with end-users, technical staff, and all project stakeholders.
• Must have a Baccalaureate degree from an accredited college in Biology, Chemistry, and/or Information Technology
• Must be able to plan, organize, and prioritize tasks to meet project deliverables in a timely manner.
• Experience working in a Regulated environment is desired
• Experience with Standard Operating Procedures (SOPs), change controls, deviations, and CAPAs.
• Highly organized and self directed; detail-oriented with no loss of big picture objectives; results oriented, a fast learner and accepting of change; ability to prioritize and multi-task effectively.
• Excellent written/verbal communication skills
• Basic laboratory experience.
Source: Job Diva – Job Listing
Client IT is looking for an experienced and hands-on Sr. Application Analyst (entry level manager) to manage projects and other deliverables for Corporate Application systems. This is a customer service focused position and needs the right mix of functional and project management skills.
This position will work closely with Finance business users, IT teams, project teams and help manage day to day IT operations and projects in pipeline.
Key Responsibilities
– Collaborate with business users, IT support team and IT team lead to gather and document requirements, deliverables and manage tasks across multiple small scale projects
– Architect/Propose solutions in SAP FICO & SD / other Financial applications to meet Finance team’s needs
– Assist in testing and documentation across applications
– Vendor co-ordination for in pipeline applications
– FIT/GAP analysis for identified solutions
Qualifications :
Successful candidate will demonstrate following qualities –
– Project and people management skills and the ability to lead and work as part of a team
– Ability to maintain open and frequent communication with support teams and internal stakeholders
– Excellent written and verbal communication skills
– Experience to lead or manage multiple projects simultaneously is a plus
– Ability to maintain detailed documentation in a GXP environment
Experience
– 5 Years of experience in financial application management and support, primarily – SAP – FICO & SD, TM1, Concur, Readsoft, Model N etc.
– Strong proficiency in Office applications is desirable.
– Biotech/Lifesciences experience is a plus
Source: Job Diva – Job Listing
The Technical Writer is accountable for driving results in a fast-paced multi-faceted environment by providing project/study and investigation support through review and technical writing of GMP documents, SOPs and other documents associated within QC area of responsibility. Assignments are of varying complexity, where sound judgment and self-drive/initiative are required to resolve problems and make recommendations/decisions.
Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization. Other writing tasks as applicable
Proofread documents for content and identify non-standard format or wording, and errors within documents
Organizes data into clear and concise professional presentations
Maintains consistent, accurate, and up-to-date notes and files
Analyse and review data where required pertaining to documents being drafted
Present authorship strategy to management to get pre-approval and endorsement.
Lead assigned projects to in advance of required timelines
Support cross-functional teams when required
Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval. Escalate any issue/delay to management as applicable
May be required to support data mining activities and database establishment of existing raw data
Performs other job duties as assigned
.
Thorough knowledge of ISO, ICH, FDA/EMA/JP and cGMP requirements
General knowledge of analytical test methods
Experience using LIMS/Subway/Agile/TEDI/Trackwise systems
Advanced written and verbal communication skills
Mastery of Microsoft Word and proficiency in Excel
Advanced experience in the use of computer based systems and applications
Advance experience in drafting cGMP Protocols, reports, SOPs, Forms etc with management oversite.
Source: Job Diva – Job Listing
Qualifications:
· A BS/BA in Computer Science/Information Technology or related field
· Minimum 2 years experience designing and building EDC clinical databases using ORACLE InForm.
· Experience programming in SAS a plus
· Working knowledge of relational database development, SDLC methodologies and CDISC SDTM Implementation Guidelines/Process
· Understanding of regulatory guidance documents (e.g. GCP, ICH, 21 CFR Part 11, etc.)
· Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach
· The candidate must be able to balance multiple projects simultaneously to take on additional projects and work overtime when necessary.
Source: Job Diva – Job Listing
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