Gxp & Research Applications In California
This is a new opportunity for a director, gxp & research applications full-time position in california.
reporting to the vp of information technology, this position will be responsible for defining and maintaining global gxp and r&d application services. The successful candidate will have extensive experience with pharmaceutical and biotech it systems, vendor management, cross-functional team management, cfr part 11 and gamp 5 regulations, systems validation, and change control.
This position will provide leadership to the application services team and the company. It will consult with the business to achieve successful gxp and r&d system development and completion of the it department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to application services staff while establishing and maintaining positive relationships with relevant business partners.
-provide production and development support for existing and future multi-tier gxp and research applications.
-execute agreed upon service levels (i.E. Project schedules, system availability, & service quality).
-review systems requirements and prepare recommendations anticipating future application needs.
-direct the analysis, design, development and installation of it supported applications in accordance with established sops.
-direct the it process development team to establish and maintain it sops, wis and related documents.
-partner with qa to manage systems validation, periodic reviews and vendor assessments.
-prepare operational forecasts and requirements, including monthly reports and budget analyses.
-provide regular performance feedback to employees including written performance reviews.
Lead individual projects as assigned using software development life cycle (sdlc) methodologies.
-bs degree in computer science, business or equivalent experience.
-ten to fifteen years of experience supporting gxp it systems with 3 to 5 years’ experience in the following:
-it biotech project management experience in a multinational environment;
-it management experience in a biotech/pharmaceutical environment managing systems supporting drug safety, pharmacovigilance, regulatory compliance, quality management and compliance, medical information or clinical trials software; and,
-it working knowledge in a biotech research and lab environment, familiar with lab systems implementation and system requirements.
-working knowledge of cfr part 11 requirements and direct experience with systems implementation in a validated environment.
-must possess an understanding of business processes related to pharmaceutical corporate activities.
Contact us here on zintro for more details.+6 Other Responses
Pharmaceutical Sales Strategy
Dear experts, this is my third enquiry here, at zintro. We are developing a new proprietary medicine, it is a nasal spray, for cns. It is not for any heavy conditions, like schizophrenia or alike. It is also very safe from preclinical data. Phase 1 is just starting. We need to understand, where is the fastest way to market - in usa or in europe? We need to compare expenses and time taken to marketing authorization and then to market in usa and in europe for our type of drug. We have budget for this work. I look forward to your answers. Mikhail+24 Other Responses
New Jersey Pharmaceutical Compliance
Compliance specialist - bergen county nj
essential job function: responsible for interacting with customers on quality issues. Responsible for the receipt of all notices of investigations and logging them into the investigations spreadsheet. Responsible for the receipt of independent capas and logging them into the capa spreadsheet. Responsible for reviewing investigation reports for accuracy, compliance and completion. Responsible for performing internal and external audits and completing the pertinent audit agenda and reports.
• pharmaceutical background
• excellent documentation
• bachelor's degree, in science field desired
• 3-5 years investigation experience
• 5+ years in qa role in pharma industry
• at least 2 years of auditing experience
• 3-5 years working in a department responsible for assigning and assessing the effectiveness of capa’s
• solid oral dosage experience, would also consider a candidate with experience in liquids, semi-solid, capsules, injectables (if candidate possesses all other qualifications!)
general information: experience in the pharmaceutical industry. Bachelor’s degree in science field desired.
Job responsibilities include but not limited to:
• investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident.
• perform root cause analysis.
• perform product impact assessment of deviations.
• provide qa support during the investigation process.
• perform tracking and trending of deviations and capas.
• prepare deviation and capa metrics on a monthly basis.
• provide support during fda inspections.
• responsible for the receipt all notices of investigations and logging them into the investigations spreadsheet.+4 Other Responses
Technical Writer Gxp Process
This is a contract opportunity in california: technical writer gxp process
the technical writer will primarily be responsible for working with internal it and other gxp partners to identify content needs, develop, revise, format and publish standard operating procedures (sops), work instructions (wis} and validation documentations. Additionally, the consultant will assist by supporting the it function with incident management, ca/pa (corrective action and preventative action), audit management, change management and vendor management processes.
-author sops, wis and forms in compliance with our documentation management process and procedures.
-work with staff to define business requirements and process solutions.
-work closely with it and functional subject matter experts (smes} to determine the content for sops, wis and forms.
-participate in review sessions of sops, wis, and forms to incorporate comments and/or changes, as applicable.
-complete assignments in accordance with set standards related to format, order, clarity, conciseness, style and terminology.
-provide status updates on all documentation milestones.
-work with project teams to identify, analyze, prioritize, document and communicate project risks to mitigate impact to project deliverables and timeline.
-must possess the ability to quickly develop and maintain a high level of knowledge and understanding of our existing solutions and documentation.
-requires an understanding of cfr part 11 and gamp5 provisions as they apply to systems management and deployment.
-must be resourceful with a strong customer-service orientation and commitment to provide timely and quality solutions to customer issues.
-demonstrated excellent written and verbal communication skills. An effective listener able to convey information in an accurate and concise manner and understands when to seek feedback.
-effective presentation skills with the ability to deliver information to a broad range of audience.
-must be well-organized, self-directed, and a team player.
-highly effective in prioritizing and organizing work plans and activities to deliver on objectives on time and within budget.
-must be detail oriented, with strong analytical and problem solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems.
-must possess a strong understanding of business processes related to pharmaceutical corporate activities
contact us here on zintro for further details.+13 Other Responses
Pharmacovigilance Business Development
Job title: business development manager
job location: open (us and uk)
job type: full-time
please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please.
will work collaboratively with other colleagues to increase sales within the life sciences industry. Responsibilities will include full cycle sales including; researching, identifying, cold/warm calling, getting client meetings, listening and understanding client needs, addressing client concerns/objections, proposing solutions, negotiating, obtaining sows and closing the deal. Are expected to quickly develop credibility with customers/prospects and build trust through professionalism and knowledge of our services and products.
**essential duties and responsibilities**:
- prospect accounts focusing on safety related to our products and services
- identify and develop new accounts and following up on existing leads
- develop and maintain positive and productive relationships with key target accounts
- manage assigned accounts to generate both incremental and repeatable annual business
- initiate and manage rfi and rfp process and negotiate terms for all account programs and projects
- work collaboratively with the services organization to ensure a complete and professional delivery of our software and service solutions
- collaborate with our executives and smes to maximize account coverage
- maintain knowledgeable understanding of changing regulatory guidelines and mandates affecting the industry community
**job experience and qualifications**:
- must demonstrate a sustained (7+ years) and successful track record selling professional services to pharmaceutical, biotech, medical device, and/or clinical research organizations.
- selling drug safety consulting services and products is desired.
- candidates should exhibit an understanding of the regulatory pharmacovigilance process for both pre-marketed and post-marketed stages of a product.
- experience working with regulatory affairs departments, product safety related departments, or regulatory submissions is highly desired.
- experience with data-mining or statistical signal detection products is desirable.
- demonstrated track record of success working with senior level management in a fast paced growth environment is essential.
- full sales cycle experience is required (prospect, identify opportunities, propose solutions, negotiate, close).
- strong, quality-oriented proposal writing and proposal management experience.
- ambitious, driven and self-motivated personality is required.
- college degree or equivalent experience required.
- willing to travel throughout the us, estimated up to 80%.
- background in software as a service (saas) market is preferred.
- competitive base salary + commission.
- benefits: 100% medical/dental for employee and his/her family.
Interested applicants should reply with a brief summary of their relevant experience and attach their latest cv on zintro.
Please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please.+49 Other Responses
I work at a human capital sourcing firm and am trying to find an expert or a consultant that can help me answer some questions about a potential investment.
I am looking for someone who can help me better understand single-source providers of medical information, pharmacovigilance, and regulatory compliance concerning pharmaceutical development. If a candidate has international experience, experience in both pv and mi, experience in asia would be a huge plus, but not mandatory.+27 Other Responses
We are a renowned boston venture capital firm looking for a gxp expert for compliance and auditing consulting for one of our portfolio companies selling software into pharma.+26 Other Responses
Drug Quality Security Act
We’re interested in speaking to experts in the field who are familiar with regulations around dqsa – which is a regulation regarding compliance of the pharmaceutical supply chains (http://www.Fda.Gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/)
do you know anyone that might be able to help? Zintro will pay $100 to anyone that refers an expert that gets selected by the client.+undefined Other Responses
Job title: argus implementation engineer
job location: parsippany, nj
job type: full-time
please note: this position is only open to u.S. Residents/citizens seeking full-time employment. No consultants please.
- argus implementation engineer will work collaboratively with other colleagues to satisfy current client’s needs through our managed services offerings.
- willing to travel to clients on an “as needed” basis
- 5-7 years of experience
- must know argus drug safety suite. Willing to look at folks that have worked with arisg as well
**essential duties and responsibilities**:
- strong with integration and configuration related to argus safety suite:
- argus interchange, argus safety, argus insight (3-5 years exp.)
- axway interchange (3 to 5 years exp.)
- ability to write technical documents (design/technical specifications, installation/operational qualifications)
**salary**: depends on experience (doe)
**benefits**: 100% medical/dental for employee and his/her family
interested applicants should reply with a brief summary of their relevant experience and attach their latest cv on zintro.
Please note: this position is only open to u.S. Residents/citizens seeking full-time employment. No consultants please.+7 Other Responses
Usp 800 Compliance
My company incorporates many physician-based clinics. A couple of clinics have compounding areas. We are looking for a consultant who would help us evaluate current state and become compliant with usp chapter <800> (and <797>). Our final decision would be based on "what else" the vendor brings to the table, cost of basic services aside. For example, will the vendor provide continuing education opportunities, or how often will the vendor come on-site.+8 Other Responses
We are looking for compliance experts in the pharma industry in europe. Post a discussion with the experts, we may want to develop an alliance to conduct compliance related trainings in europe. Please send your brief profile to **** for further communication.+11 Other Responses
Looking for global qppv psur and pv/drug safety consultant for an ongoing project in basel, switzerland. This is a backfill for someone who is leaving in december so immediate availability is necessary. Message me for more details? Thx!+27 Other Responses