The Drug Supply Packaging Coordinator supports secondary packaging and distribution of clinical supplies for US Clinical Development Medical Affairs in Fort Worth, Texas. Additional responsibilities include shipment tracking, drug accountability and copying/filing of GMP documentation.
Major Activities:
1. Responsible for labeling/kitting, distribution and accountability activities in support of the US Pharma portfolio.
2. Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation.
3. Demonstrates an understanding of *** systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody.
4. Creates, updates, reviews, maintains and archives records and other key documents to provide track and trace evidence for every aspect of the secondary packaging and distribution of investigational product in a cGMP state.
5. Accountability for specific record types will be based on job assignments. If label printing is a part of job assignments, demonstrates knowledge of labeling requirements along with the knowledge of printing clinical labels.
6. Demonstrates good working knowledge of inventory management best practices. This may be inclusive of any of the following, log books and their correct entry, WIP, quarantine, retention samples, reference samples, released goods, returned and discarded goods
Some experience with labeling, packaging and/or shipment of clinical supplies (preferred)
Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements (preferred)
Great attention to detail.
Excellent organizational and documentation skills
Excellent communication & customer relation skills.
Excellent written and spoken English.
Source: Job Diva – Job Listing
POSITION OVERVIEW
Senior Security Architect is responsible for collaborating with stakeholders in evaluating security architectures, recommending security postures, and contributing expert knowledge towards security strategy, governance, risk management, regulations & compliance that sustains current and future critical systems that manage the power grid for 42 million people and 190,000 megawatts of power.
The ideal candidate has a passion in securing systems in an environment that fosters cloud architectures, agile processes, and modernizing technologies & processes; enjoy systematically engaging stakeholders and applying security methods and producing analysis, reports and artifacts across multiple domains including business, data, application, infrastructure, and security to evidence the achievement of security, risk, regulation & compliance objectives.
To be successful, the ideal candidate enjoys driving standardization, security best-practices, evaluations, problem-solving through collaborating well with other teams and is comfortable working well in a dynamic environment.
We are looking for someone that shares our passion for security, risk, compliance while enabling software where your contribution has a positive impact on society. If you love working in a complex domain and want to contribute to evolving & transforming technologies & processes to solve these problems, this is the job for you.
ESSENTIAL RESPONSIBILITIES
Collaborate with business and technology stakeholders, including directors, executives, managers and engineers to conceptualize to-be architecture designs that achieve desired trade-offs across technology strategy, business goals, and security outcomes.
Participate in Risk Management processes, perform risk assessments and plan mitigations
Rationalize, evaluate and design security tools and services
Contribute to the development and implementation of security controls, policies, and procedures
Assist development teams in the adoption of DevSecOps practices into the application lifecycle
Analyze threats to ensure the secure design of applications and solutions
Periodically, participate in security assessments, including pen tests, vulnerability assessments, internal and external audits, and simulations
Lend insights to the practices, technologies, and procedures for security incident response and recovery
Direct vendor engagement to ensure alignment with MISO security standards
Develop and maintain the Reference Architectures for ensuring the security of the Enterprise
Contribute exemplars of executed security patterns and technology to MISO’s Reference Architecture
Compliance with all processes, procedures, and standards applicable to the position including (but not limited to): SSAE16 SOC1 (Statement on Standards for Attestation Engagements No. 16 Service Organization Controls 1), CIP(Critical Infrastructure Protection), Change Management, Tariff (Open Access Transmission, Energy and Operating Reserve Markets Tariff), FERC (Federal Energy Regulatory Commission), NERC (North American Electric Reliability Corporation), U.S. Department of Homeland Security, and NAESB (North American Energy Standards Board)
Complete all other duties as assigned.
EDUCATION/ EXPERIENCE
Bachelor’s degree in Computer Science/Engineering, Network Security or equivalent work experience.
Advanced Security certification preferred, such as CASP, GIAC, CISSP, CISM
7+ years of experience in Information Technology;
5+ years of experience in Security.
3+ years of Security Architecture experience.
TECHNICAL KNOWLEDGE, SKILLS, AND CAPABILITIES
The requirements listed below are representative of the knowledge, skills, and abilities required to perform each essential duty satisfactorily.
Security Frameworks – Deep knowledge of Security Frameworks (NIST 800-53, ISO 27002, COBIT) and industry standards (NERC CIP, SOC)
Risk Modeling – Mastery of risk modeling methods (CIA, FIPS199)
Threat modeling – Good understanding of application threats and their mitigations, Proficient with one or more threat modeling methods (STRIDE, OCTAVE, Trike, ect)
Security Evaluations – Extensive knowledge on security assessment methods and techniques
Cloud – Familiarity with cloud security frameworks (FedRAMP, Cloud Control Matrix)
Strong knowledge of network security components, network design concepts, and network monitoring and management practices
Thorough understanding of the technologies, processes, and protocols of Identity and Access Management
Practitioner-level familiarity with security technologies (IDS/IPS, DLP, SIEM, NAC, etc)
Knowledgeable about the integration of security with modern software delivery practices, methods, and technologies
Monument Intake Notes
MISO is seeking a resource to act as a bridge between the cyber security and architecture teams. In this role, MISO is looking for a resource to develop security policies and procedures to be upheld throughout the organization. This resource will be leading discussions on security and risk management, so this resource will need to have excellent communication skills.
o This person will be communicating with executive level leadership on a regular basis, both effectively and persuasively in order to enact security policies
It is preferred that this resource have experience with private cloud technologies, but more importantly, this should be a resource that is proactive in learning these new cloud technologies on a regular basis, as these technologies are continuing to evolve and change.
Strong familiarity with well-known security frames is needed
Strength in both Network and Application Security is strongly preferred
Please have your candidates answer the below questions to the best of their ability, and copy their responses to the top of their resume – Candidates without these answers will not be considered
1. Briefly describe a specific architecture (system or sub-system) that you developed and/or contributed to
2. Describe at least one architecture trade-off decision that you made in support of the above.
3. What value did the business gain as a result of an architecture that you developed and/or contributed to?
4. After realizing the above architecture, how do you determine if that decision was the correct one?
5. After realizing the above architecture, how do you determine if that architecture was successful?
6. Describe a time when you had to present a technical topic to a non-technical person.
Source: Job Diva – Job Listing
Supports appropriate processing, revision and control of quality documents in the Document Control Room.
Responsible for issuing, receiving and archiving of quality records processed through the QA Document Control Center.
Support following Document control activities:
1. – Support scanning of documents (Incoming materials, sanitization logs, pest con-trol logs, etc.), filing documents, also supports onsite and off-site archiving of doc-uments
– Maintain document storage rooms to ensure accurate archive and easy retrieval.
– Retrieve requested records, including logging out records and following up to ensure prompt record return.
– Order supplies/logbooks, organize batch record binders and Print Lab Data Sheet
– Assist in Batch Record Issuance (e.g. Patient BR, Training BR, qualifications etc.)
2. Support QA Compliance activities such as tracking/following up on projects/tasks associated with QEs/Actions/CAPAs
3. Prioritize tasks based upon departmental objectives and business criticality
4. Support project related activities (e.g. help with, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, quali-fication and facility upgrade activities, IT validation projects) as per area of respon-sibility.
5. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidances, SOPs etc.).
Provides timely and accurate document support to all GMP functions at CGTDM East Hanover Facility
Communication skills to sufficiently address GMP and logistic related questions with the line unit experts.
Basic knowledge of drug development and CGT development is a plus.
Detailed knowledge of cGMP and document management, working knowledge of safety and environmental regulations and guidelines.
Good organizational skills.
Technician > 3 years experience
Bachelor with > 1 years experience
Source: Job Diva – Job Listing
Responsible for the collection, data entry, routing, follow-up, and timely reporting/submission of safety information (including expedited and aggregate reports) related to drug products from a variety of sources (clinical trial, spontaneous, literature) in compliance with SOPs and regional & international regulations. This position is especially important in light of the approval and marketing of products and the number and diversity of clinical trials. Authorities conduct periodic, detailed audits to ensure integrity of AE processing, thoroughness of documentation, accuracy of results, and timeliness of reports. This position is also responsible for self-initiated quality review within each distinct process step. Years of Experience: 3 – 6 Years
Source: Job Diva – Job Listing
The Sr. Project Manager is accountable for the
successful
implementation of technical solutions through effective planning and execution throughout all
phases of our project management methodology. You are responsible for resource
management, tracking budgets and financial forecasts, creating and tracking detailed project
plans, effectively leading and facilitating project meetings as well as proactively controlling
project scope, risks and issues. Additionally, the person in this position must effectively manage
the projects across global locations and time zones and be able to travel internationally as
needed.
Duties:
Define, plan, and direct the execution of a broad range of projects
while balancing the competing demands of scope, time, cost, quality, resources, and risk to produce a high
quality product
Identify, acquire, and lead multifunctional, global project teams
Ensure project objectives/requirements are clear and agreed to by all stakeholders
Manage relationships with various IT and business stakeholder to achieve project
objectives
Facilitate project management activities across the entire project management
methodology
Ensure successful and timely completion of deliverables
Track progress against baseline schedule
Plan, baseline and control costs to ensure projects are completed within approved
budget.
Manage project priorities and ensure adherence to the agreed scope.
Monitor, document and gain approval for changes to schedule, cost or project scope.
Identify and apply systematic quality activities to ensure that projects employ all
processes needed to meet Computer System Validation directives
Conduct risk and issue management planning, identification, analysis and monitoring on
projects.
Formulate risk and issue mitigation strategies, recommend and implement solutions.
Manage the processes required to ensure timely and appropriate generation, collection,
distribution, storage, retrieval, and ultimate disposition of project information and
documentation necessary for successful communications across all stakeholders and
any required updates to living system documents for validated systems
For this position you will bring the following qualifications:
– 10+ years’ experience in proj mgmt
– 8+ years’ experience in management of global projects
– Experience in management of senior stakeholders
– Experience with GxP relevant systems
– Experience with vendor management
– Experience with deployment of cloud solutions
– Flexibility in working hours: early mornings
– infrastructure knowledge/experience
It's a technical PM position so the candidate should have the technical background with experience leading
projects as Technical PM.
Source: Job Diva – Job Listing
POSITION SUMMARY: Responsible for initiating, directing and executing scientific research, development and manufacturing process strategies to support new and existing products. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the art principles and theories. Makes contributions to scientific literature and conferences. Serves as an in-house and outside consultant. May act as a spokesperson for corporate scientific affairs and advise top management. Participates in development of patent applications. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways. ESSENTIAL FUNCTIONS: – Conducts research and development activities for products, methods and/or processes. – Projects are assigned with defined scope and goals. – Direction is provided by more senior scientists, management or project leader. – Participates in efforts to define new components, products or processes and identify technical challenges. – Makes suggestions to improve work processes. – Creates potentially patentable components for systems, reagents or processes. – Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques. – Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements. – Applies advanced scientific knowledge to projects. – Executes experiments; participates in experimental design. – Utilizes DOE where appropriate. – Participates in cross functional technical team activities. – Shares knowledge and expertise with others. – Participates in project planning, process updates and contributes to experimental design. – Prepares and delivers presentations of project results to own or other groups. – Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills, and Abilities: – Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. – Strong understanding of scientific principles and concepts. – Applies advanced technical writing skills to produce reports and documents.
Source: Job Diva – Job Listing
Support a Biopharmaceutical Drug Product Development project (Biologics, Gene Therapy, Protein therapeutics or applied research) using biophysical characterization techniques (liquid and solid state/lyophilized). Coordinate lab activities and maintenance of lab systems. Responsible for the execution and analysis of experiments and analytical procedures for stability testing, formulation or process screening and container closure selection. 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 independently. 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 independently but with active supervision and team interaction. 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. Good communication skills (oral and written), a strong work ethic, and good documentation practices including laboratory notebook maintenance, and compilation and presentation of data. Works well with others and has the flexibility and adaptability needed in a fast-paced team environment. Years of Experience: 3-6 Years
Source: Job Diva – Job Listing
Required:
Knowledge of cGMP and applicable FDA regulations
Bachelor’s degree in a scientific discipline or equivalent with 3+ years relevant industry experience in a cGMP/FDA regulated environment
Very detail-oriented team player with effective planning, organization, and execution skills
Excellent communication skills with internal and external personnel essential
Strong computer skills with Word and Excel
Ability to work effectively at a fast pace
Innovative, proactive, and resourceful; committed to quality and continuous improvement
Source: Job Diva – Job Listing
Manager, Biostatistician
DESCRIPTION:
Work with the clinical study team on study design, development and/or review of clinical study protocols.
Contribute to clinical trial design, protocol concept sheet and protocol development
Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others
Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed.
May work on submission teams as a statistician and/or a programmer.
Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
Will serve as lead Statistician on complex trials and across multiple studies.
Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.
Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.
Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed.
QUALIFICATIONS:
Must have a MS in Biostatistics/Statistics with at least 8 years of experience or a PhD in Biostatistics/ Statistics with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.
Strong SAS programming skills.
Oncology experience is required.
Ability to effectively work on multiple projects
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 leads problem solving within the team
Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus.
Source: Job Diva – Job Listing
***-Client has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Our portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a part of ***, we benefit from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
The Laboratory Technician I position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston, MA. The global MSAT team is within the Industrial Affairs (IA) unit of ***-Clients Specialty Care organization.
The Team is responsible for providing laboratory-based technical support to *** biologics. The Team recently designed a state-of-the-art laboratory with capabilities to support small-scale models of the commercial cell culture and purification operations, as well as analytical testing.
The Process Science team member will:
Learn and execute protein stability studies on liquid, frozen, and/or lyophilized formulations
Perform analytical work such as UV spectrophotometry for protein concentration and HPLC (high performance liquid chromatography) for product purity to support in-process sample testing and quality control
Participate in design and execution of experiments using small-scale models, analyze and interpret results, and recommend additional experiments. Utilize this knowledge to expand process understanding and drive improvements in the commercial manufacturing operations including improving process robustness/reliability.
Apply design space knowledge to support effective investigations and root cause analysis
Use scientific principles and professional practices to solve a range of complex problems in creative and practical ways
Preferred Qualifications include:
Bachelors/Masters degree in Chemical Engineering, Biochemistry, Biology, or relevant field with 0-3 years of experience
Effective communication & presentation skills
Experience in biologics stability studies is beneficial
Experience with aseptic technique is beneficial
Understanding of protein stability, characterization, and/or analytical analysis theory preferred, but not required
Source: Job Diva – Job Listing
Job Summary:
Candidate will contribute directly to the Tech Transfer project between Client sites. As a member of the MTech and Quality teams at PSC, the candidate will provide right level of support to the transfer from sending site in terms of technical, documentation, and training support. Ensure the transferred process and analytical methods perform to expectations and demonstrate good consistency and robustness, and ensure the resulting operation added to the receiving site be sustainable, reliable, cost effective and compliant with HSE standards.
Candidate will accomplish these tasks in a laboratory setting and through collaborations both internal and external. Responsibilities includes:
Upstream Processing MTech:
To assist in the development and execution of experiments in all upstream activities through SOPs and documented protocols. Duties will include molecular biology technics and methods, cell culture maintenance, virus expansion and preparation of seed and cell scale-up for bioreactor experiments. Secondary responsibilities will be to compile and analyze experimental data including the on-line and off-line sources and maintain database. Duties will include but not limited to operation and maintenance of bioreactors through execution of SOPs and protocols, data mining and analysis. Tertiary responsibilities will be to assist in basic laboratory analytical techniques. Duties will include SDS-PAGE, Western blots, SRID assay, pH meters, etc. The candidate is capable of identifying and troubleshooting the USP operation problems in small-scale bioreactors, participates in the process improvement program and provide support to the receiving site for mitigation studies and training.
Downstream Processing MTech:
Responsible for the development of seasonal and pandemic purification processes, as well as optimizing existing purification processes, and testing of new process and product for purity, yield and other biochemical characterizations. Involved in influenza program for the process scale-up, purification, process optimization, technology transfer, and process validation activities. Support tech transfer project with process/ product expertise and training for receiving site.
Quality Department
Responsible for training on, understanding, and following documented procedures which apply to QA and QC departments.
Works with all QC Lab functions to support release testing of samples.
Serve as technical support for analytical method assessment of sending site procedures (MTech and QC); support analytical method transfers from sending site to receiving site.
Methodologies for the labs may include the following: molecular biology methods, microbiological/ virology methods and other biochemical testing methodologies supporting both licensed products and new vaccine projects.
Prepares technical reports, summaries, protocols, and quantitative analyses.
Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways and other such duties and responsibilities as may from time to time be reasonably assigned.
Source: Job Diva – Job Listing
Duties
*Authoring and resolution of deviations in order to meet production and product release requirements.
*Identification and facilitation of interdepartmental process improvements.
*Utilize root cause analysis techniques during deviation investigational process
*Work cross functionally, to develop and implement continuous process improvements
*Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
*Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI, etc) in accordance with cGMP and regulatory guidelines.
*Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
*Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
*Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
*Will be responsible for performing administrative tasks such as gathering and preparing documentation to support investigations and or change controls/capas
Skills
*Working knowledge of cGMP’s is required.
*Must have knowledge of continuous improvement techniques and problem solving skills.
*Previous experience working within a production department of a pharmaceutical company.
*Technical Writing experience preferred
*Candidate must be able to work extended and flexible hours (including weekends) when needed.
Education
Bachelor degree and 3-5 years experience.
Source: Job Diva – Job Listing
The mission of Customer Service (CS) is to provide compassionate, knowledgeable and efficient service to consumers and healthcare providers. The CS Representative is a critical role, responsible for providing resolutions to customer inquiries from multiple channels as well as data capture for customer trending and product issues. Qualified candidates will be comfortable in a multi-tasking in a high-energy environment.
Skills/Knowledge
Strong organizational skills and attention to detail
Excellent communications skills verbal, written and listening
Computer Skills MS office suite, Basic/Intermediate (Outlook, Word, Zoom, Skype)
Accountability/Responsibility Takes ownership of both successes and failures.
Process Knowledge Understand procedures and processes.
Adaptable Positively embrace different situations and provide options
Communication Skills Employ strong listening skills and convey information clearly to audience using a tone that balances friendliness and professionalism.
Professionalism maintain composure by demonstrating patience and restraint.
Position information positively while utilizing call handling skills.
Knowledge of SAP preferred
Summary/Scope
Prior customer service experience required – Desired, 3-5 years.
Previous pharmaceutical experience preferred
Position requires the use a phone w/headset and sit for extended periods of time.
Arrive to work on time and adhere to schedule
Basic understanding of standard call greetings and situational call handling.
Ability to communicate clearly and concisely, both in writing and verbally.
Process product replacements for healthcare professionals and consumers.
Recognize potential adverse events and product quality complaints.
Provide exemplary service to patients, Health Care Professionals and sales reps.
Carry out special duties as assigned by management.
Ability to contribute to a team environment as well as function independently
Provide timely and useful updates on orders to the customers
Mandatory overtime when business needs arise
Flexible schedule required
Source: Job Diva – Job Listing
Provide input into identifying implications of study progress on overall timeline goals and conduct plans. Provide input into content and execution of investigator meetings and may present selected topics. With oversight, develop informed consent form and coordinates input. With oversight, provide point of contact for site questions relating to study conduct issues. Participate in the implementation of key organizational process improvement initiatives. Responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases I-IV). Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation. Lead the multi-disciplinary team responsible for study completion. Write and review abstracts/manuscripts, etc. for presentation/publication at internal/external meetings. Experience in Clinical Trials or Clinical Project management. Experience with Investigator Sponsored Trials. Bachelor's Degree/Undergraduate Degree (or equivalent). Years of Experience: 6 – 9 Years
Source: Job Diva – Job Listing
Remote Position until further notice. Will eventually be based in Waltham, MA or other MA Site.
The Global Product Supply Lead (director level) will be accountable for:
Managing End to end (E2E) Supply Chain for a Product or Set of Products
Balance Demand & Supply in the tactical (0-12 Mo) and strategic (12 mo to 10 year) horizons.
Optimizing the inventory and service for the products in scope
Single point of escalation for product supply escalation
Managing global crisis & monitors volumes (Any broad-based allocation or supply disruption challenges)
Representing product supply in the global Integrated Business Planning (IBP) process
Maintain Product(s) Risk Assessment and Mitigation Plan
Drives and supports new product launches & other life-cycle programs
Cost reduction initiatives
SKU complexity reduction (Regional or shared language pack)
Pre-launch clinical activities, in conjunction with iCMC lead
Sourcing selection
Setting product supply policies across the network within guidance
Setting guidance for Stocking and planning levels for the network nodes to include global levels as well as allowable ranges
Defining phasing of managed access and humanitarian item availability and logistics approaches through the pre-launch horizon
Coordinating the Strategic Plan development and communication with the sites and platforms
Integrating third party demand, analyze variations and confirm requirements with the direct customers.
Liaises with production and material planners to identify potential supply alerts.
Understands the impact of risks/issues on direct customers side on scheduled deliveries/FG availability.
Follows up on CMO and/or Alliance Partner supply performance up stream, when applicable.
Provides coaching and feedback to Supply Network Planner and Planning Director for development.
Co-facilitates the identification of long-term capacity needs and associated sourcing process for their products across the Platform and ultimately IA Sourcing Committees.
Source: Job Diva – Job Listing
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