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Company Jobs - AstraZeneca Pharmaceuticals



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Labeling Associate Director

Gaithersburg MD

Education, Qualifications, Skills and Experience Minimum requirements: University Degree in Science or related discipline 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labeling Knowledge of labeling regulations and guidances Excellent verbal and written communication skills Keen attention to detail and accuracy Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. Ability to assimilate clinical and scientific information and present it in a concise manner Ability to think strategically, appropriately assess risks and formulate strategies to manage risk Must demonstrate competencies in: Building Relationships (works well across formal and informal networks) Negotiation Skills (good listener; able to build a consensus) Critical Information Seeking (works well across formal and informal networks) Rational Persuasion (able to distil an issue to its key components and suggest solutions) Interpersonal Awareness (aware of how actions affect other people) Preferred Background: * Experience in Labeling development and/or maintenance * Knowledge of major markets Labeling regulations * Advanced academic training is highly desirable (PharmD, PhD) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationMD, Gaithersburg UK, Macclesfield CategoryRegulatory Affairs Date Posted10/21/2014 Req Number14-50107906 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Labeling Manager

Gaithersburg MD

Education, Qualifications, Skills and Experience Minimum requirements: University Degree in Science or related discipline 3 years pharmaceutical experience, preferably regulatory experience, preferably working with labeling Knowledge of labeling regulations and guidances Excellent verbal and written communication skills Keen attention to detail and accuracy Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. Ability to assimilate clinical and scientific information and present it in a concise manner Ability to think strategically, appropriately assess risks and formulate strategies to manage risk Must demonstrate competencies in: Building Relationships (works well across formal and informal networks) Negotiation Skills (good listener; able to build a consensus) Critical Information Seeking (works well across formal and informal networks) Rational Persuasion (able to distil an issue to its key components and suggest solutions) Interpersonal Awareness (aware of how actions affect other people) Preferred Background: * Experience in Labeling development and/or maintenance * Knowledge of major markets Labeling regulations * Advanced academic training is highly desirable (PharmD, PhD) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationMD, Gaithersburg UK, Macclesfield CategoryRegulatory Affairs Date Posted10/21/2014 Req Number14-50101404 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Project Manager/Sr. Project Manager - Operations

Gaithersburg MD

Education/Experience For Project Manager: BS in Engineering or Science is required + 5-10 years of Project Management experience For Senior Project Manager: BS in Engineering or Science is required + 8-15 years of Project Management experience Preferred Experience: 5 years minimum experience in the pharmaceutical or biopharm industry in a manufacturing or related role Demonstrated track record of success in delivering strategic, complex, cross-functional and multi-site projects on-time, on-budget and to committed deliverables to generate significant business value Technology transfer or new product launch experience Strong knowledge of pharmaceutical/biopharm GMP Experience in a biopharm operations a plus but not required Project Management Certification is a plus but not required *LI-MEDIPRI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationMD, Gaithersburg CategoryOperations Date Posted10/21/2014 Req NumberM8487 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Regulatory Affairs Manager

Gaithersburg MD

Minimum Requirements --Education and Experience University Degree in Science or related discipline Five year experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority Leadership skills, including proven leadership of cross-functional project teams experience Excellent written and verbal communication skills Thorough knowledge of the drug development process Thorough scientific knowledge sufficient to understand all aspects of regulatory issues Preferred Experience Knowledge of AZ Business and processes Skills and Capabilities (see attachment for details) Strategic thinking Influencing Problem solving Flexibility/ Adaptability Independence Delivery & Results Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationMD, Gaithersburg CategoryRegulatory Affairs Date Posted10/21/2014 Req Number14-10051320-1 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Diabetes Sales Specialist - D2 - Cincinnati N, OH

Cincinnati OH

Qualifications: Education: -Bachelors degree (any major) from an accredited college or university is required. Experience: - Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred, but not required - Demonstrated effective organizational and communication skills - Leadership, self--motivation and initiative - Demonstrated judgment and decision-making capability - Be results oriented with demonstrated time management skills - Ability to learn, analyze, understand and convey complex information - Demonstrated technical aptitude and computer skills are essential - A valid driver's license and safe driving record Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationOH, Cincinnati CategorySales Date Posted10/21/2014 Req Number14-50090603 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Diabetes Sales Specialist - D1 - New Brunswick, NJ

New Brunswick NJ

Qualifications: Education: -Bachelors degree (any major) from an accredited college or university is required. Experience: - Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred, but not required - Demonstrated effective organizational and communication skills - Leadership, self--motivation and initiative - Demonstrated judgment and decision-making capability - Be results oriented with demonstrated time management skills - Ability to learn, analyze, understand and convey complex information - Demonstrated technical aptitude and computer skills are essential - A valid driver's license and safe driving record Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationNJ, New Brunswick CategorySales Date Posted10/21/2014 Req Number14-10052372 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Diabetes Sales Specialist - D1 - San Antonio N, TX

San Antonio TX

Qualifications: Education: -Bachelors degree (any major) from an accredited college or university is required. Experience: - Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred, but not required - Demonstrated effective organizational and communication skills - Leadership, self--motivation and initiative - Demonstrated judgment and decision-making capability - Be results oriented with demonstrated time management skills - Ability to learn, analyze, understand and convey complex information - Demonstrated technical aptitude and computer skills are essential - A valid driver's license and safe driving record Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationTX, San Antonio CategorySales Date Posted10/21/2014 Req Number14-10052853 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Diabetes Sales Specialist - D2 - Racine, WI

Racine WI

Qualifications: Education: -Bachelors degree (any major) from an accredited college or university is required. Experience: - Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred, but not required - Demonstrated effective organizational and communication skills - Leadership, self--motivation and initiative - Demonstrated judgment and decision-making capability - Be results oriented with demonstrated time management skills - Ability to learn, analyze, understand and convey complex information - Demonstrated technical aptitude and computer skills are essential - A valid driver's license and safe driving record Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation LocationWI, Racine CategorySales Date Posted10/21/2014 Req Number14-50090163 NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com. AstraZeneca Making a Difference AstraZeneca is an equal opportunity employer

Posted On - 10/23/2014 7:29:45 AM

Senior Admistrator

Cambridge Cambridgeshire

Demonstrated advanced proficiency across a broad range of administrative processes and procedures · Ability to exercise considerable discretion, judgment, tact and diplomacy · Demonstrated abilities to take the initiative to respond to rapidly changing priorities · Ability to work independently with only general guidance · Demonstrates a can-do approach and · Excellent time management and organizational skills · Excellent interpersonal and communication skills as demonstrated by the ability to work effectively with others at all levels of the organization and externally · Demonstrated ability to work successfully in a team environment · Some Project management skills to effectively manage events/small projects on behalf of the customer · Knowledge of the drug development process.

Posted On - 10/23/2014 7:29:45 AM

Clinical Site Monitor Oncology - GTA

Toronto Ontario

As Local Study Team Representative * Represent Clinical Site Monitoring on study teams from start to closure including the review of study level documents such as draft protocols, Case Report Form's (paper or electronic), Case Report Form review manuals, Source Data Verification plan. Develop monitoring tools. * Active participation in the planning and conduct of monitor training meeting to ensure Clinical Site Monitor training needs for the study are met. * Responsible for training new Clinical Site Monitors transitioning onto the study on protocol and study specific processes. * Work with Enablement to request study related system access for new Clinical Site Monitors and confirms Clinical Site Monitors ability to access systems. * Responsible for development and maintenance of study summary sheet with input from Local Study Team Subject Matter Experts. * Attends Local Study Team meetings, solicits feedback from monitoring team on study specific issues for Local Study Team consideration, and disseminates information to Clinical Site Monitors via email updates and teleconferences (as needed); may attend and present at the Investigator Meeting. * Communicate issues and risks affecting study deliverables to Manager, Clinical Site Monitoring (M,CSM)/Study Delivery Leader (SDL) for escalation to global team. * Collaborate and communicate with local and global study teams in the development of processes and expectations for Interim Analysis, Database locks, close-out visit procedures and other study related deliverables * Proactively works with Manager - Clinical Site Monitoring, Study Delivery Lead to identify potential risks to Data Base Lock, review outstanding data, Source Data Verification and Data Query reports, provide status update and follow-up requirements to assigned Clinical Site Monitors and Manager ? Clinical Site Monitors. * Provide input into risk management plan. * Regular updates to clinical site monitors on study status (challenges, issues, successes, changes in resourcing) Unspecified * University degree or College diploma (professional accreditation) in Health Sciences field * Minimum 3 years experience as a Clinical Site Monitor * Oncology experience required * Ability to work independently and manage fluctuating workloads * Ability to comprehend and understand the content of study protocols * Strong interpersonal skills and excellent communication skills * Strong attention to detail * Excellent problem solving and influencing skills * Computer skills: proficiency in Microsoft Office suite of products and internet applications * Must have valid driver's license * Overnight travel will be required * Ability to work from home * Ability to work flexible hours * Extensive use of computer * A combination of education and work experience will be considered Interviews: Only candidates who meet the minimum requirements as outlined above, will be interviewed. Internal candidates who are interested in this position must inform their manager before they apply.

Posted On - 10/23/2014 7:29:45 AM

Packing Operator Technician

Macclesfield Cheshire

The role requires early and late shift working on a 5 day shift rota * Actively promotes safe work through compliance to rules and procedures. * Delivers a prompt 1st line engineering escalation if the line stops following set up, running/repeat adjustments * Can support and receive mentor direction from the Engineering Technician in the completion of engineering activities, dependant on production availability/demand * Understands the SHE and GMP compliance and OEE performance status of the asset and report out promptly * Optimise changeovers and set up, and implements compliant improvements on time to the required standard * Executes the standard process to deliver product, on time, in full. * Proactively promotes and enforces standard work, adherence to the line plan and use the GK board to highlight issues * Responsible for coaching, training, and assessing the operating teams * Work closely with engineering and other aligned support services to ensure that packing line performance and continuous improvement projects are delivered appropriately * Work effectively as a member of the team in order to ensure that effective communication channels and efficient working practices are maintained within the working period/team * Prioritise correctly - SHE (protection of AZ Staff), then GMP (protection of patient) , finally ODD (Protection of reputation) to balance line challenges and ensure compliance with Site SHE procedures at all times * Actively participate in and deliver continuous improvement activities/projects to meet the agreed ?Operations Annual Result Vision? * Lead formal and informal training of less experienced staff and new starters to meet the line and business needs Minimum Requirements - Education and Experience Essential * Solid Pharmaceutical Experience * Significant & relevant experience of changeover and setup practices within a highly regulated environment * Operating knowledge of Tablet/Parental Packing line equipment in line with GMP & SHE requirements. * SAP PM User Certification * Knowledge of IT systems where appropriate e.g. Mercury, MSDM, Microsoft office, XFI, PCs, PLCs. * Principles of Work Planning & Control * Principles of Continuous Improvement * Quality Notification procedures * Good knowledge of Compliance SHE, cGMP and working in a 5s environment. * Computer literate and knowledge of LEAN tools * Must show attention to detail and have significant proven team-working skills and to be flexible to changing work demands * Good communication skills (both written and verbal) * Good Numeracy and literacy skills * Operational knowledge of procedures and compliance with GMP & SHE requirements e.g. COSHH, risk assessment, and manual handling in a White area Desirable * Strong Interpersonal skills to operate effectively in a challenging and rapidly changing environment * Principles of Root Cause Analysis * IOSSH Certification * AZ Core Capabilities (L1) - Change Enablement - Influencing * Proven problem solving skills * Excellent influencing, facilitation and coaching skills Skills & Capabilities These are challenging roles and successful candidates would be expected to take personal accountability for developing themselves to attain the knowledge/skills and experience required to excel in these positions through vocational, technical and specialist training programs supported and provided by AstraZeneca. * Manual role with ability to operate machinery and lift and transport equipment, products and tools * Ability to learn and adapt to changing operational requirements * Ability to undertake core tasks independently AstraZeneca welcomes applications from all sections of the community. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin and will not be discriminated against on the basis of disability.

Posted On - 10/23/2014 7:29:45 AM

Opal Manager

Cambridge Cambridgeshire

To find out more about us, please visit http://www.astrazeneca.com/Careers Accountabilities/Responsibilities * Development and management of OPAL business processes * System administration across 3 Science Units * Consultancy support to Global PM on system updates * Support development of system changes based on organizational changes * Coordinate Data Quality initiatives across the Science Units * Deliver training across the OPAL project * Identification of process/tool issues and recommended solutions * Engagement with the users to ensure correct system utilization As a Global Medicines Development OPAL Manager, it?s essential that you have: · Project/Program Management expertise · Project Management System software knowledge ?Planisware · Strong business knowledge · Awareness of the overall pharmaceutical development process · Excellent detail-oriented, flexible skills Skills & Capabilities * Project/Program Management expertise * Project Management system software knowledge ? Planisware experience a plus * Business knowledge with a proven track record * Overall knowledge/awareness of the pharmaceutical development process desirable * Demonstrates flexibility, excellent Influencing skills and is detail oriented * Excellent organizational/time management skills * Experience with Reporting software i.e. Spotfire and Business Objects a plus Competitve salary Please note the closing date for this vacancy is 24th November 2014

Posted On - 10/23/2014 7:29:45 AM

Global Medical Affairs Leader - Diabetes

Cambridge Cambridgeshire

Experience, Functional Knowledge, Business Knowledge, Education, Specialist Skills: * Medical degree of appropriate certification (MD, DO or equivalent) * Practical/ working knowledge of the Brand and Disease Area, in this case, diabetes * Demonstrated experience in developing medical strategies and plans * Experience with global OL engagement Skills and Capabilities * Patient-centered but commercially aware, values driven approach * Demonstrated project management skills to lead cross functional teams * Ability to translate data into a strategic medical plan * Proven ability to engage, influence and build effective relationships with OLs, across functional and geographic boundaries * Strong verbal and written communication skills in English * Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles * Presentation and influencing/negotiation skills (essential) * High ethical standards required Internal Contacts/Customers * GMA Leadership Team: TAVPs, VP Evidence Centre VP Medical Excellence, Exec Director Operations * Global Product Team (GPT) members * The Medical Working Groups (MWGs) -Medical Science Director (MSD) -Global Payer Evidence Directors (GPED) -Key marketing company medical leaders * The Medical Evidence Center (MEC) -Medical Evidence Directors (MED) and Leaders (MEL) -Global Publications Leaders (GPLs) -ESRO TA Directors * The Global Medical Excellence Team (GME) -Dir MSL Program -Sr Dir Medical Information -Dir Medical Academy -Nom Sig Director -GMQA Leader External Contacts/Customers * In-country Medical Teams * Regional Medical Directors * International/global opinion leaders * Leadership of International Medical Associations * Academic Institutions/Hospitals * Medical opinion leaders in Policy, Payer and HTA environment * Peers in the Industry Reporting Relationship * No direct line management/reports Budget responsibility * Responisble for the creation, delivery and management of an annual Brand Medical Budget that is aligned with GMD or GPPS budget processes (depending on the life-cycle of the product/brand) Measure of Success * Supports the successful development and medical marketing of AZ brands that deliver patient-centric medical value * Delivery of fit-for-purpose Medical Strategies and plans that include Medical Evidence Plans, which are delivered by the Medical Evidence Directors * Adds value internally, evidenced by positive feedback from TAVP, GMA LT, members of the MWG, GBTs, GPTs and all other stakeholders * Enhances the reputation of AZ in all meetings with external stakeholders, as evidenced by positive feedback from international OLs * Creates content and delivers insight for a curriculum that drives internal Medical content and capabilities training across AZ, that improves the performance of recipients Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation

Posted On - 10/23/2014 7:29:45 AM

Architect: Innovation Project Leader/2 Year fixed-term/Cambridge/Luton

Luton Bedfordshire

Relevant expertise and experience: - The ability to travel both domestically and internationally - Technical, Scientific or Business degree --- Master's degree preferred - Experience of Program Management methodologies with delivery in agile environments - Excellent communication, relationship management, and influencing skills - Proven track record negotiating & influencing across complex groups - Experience shaping innovative solutions - Experience working in global organization and across cultural boundaries - Coaching, facilitation & consultation skills

Posted On - 10/22/2014 7:18:50 AM

Labeling Associate Director

Macclesfield Cheshire

Key Relationships to reach solutions Internal and External Contacts/Customers: * GRLs/XRADs/RPMs * Patient Safety * Clinical * Regulatory personnel at the Marketing Companies * Operations * Commercial Education, Qualifications, Skills and Experience Minimum requirements: * University Degree in Science or related discipline * 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labeling * Knowledge of labeling regulations and guidances * Excellent verbal and written communication skills * Keen attention to detail and accuracy * Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. * Ability to assimilate clinical and scientific information and present it in a concise manner * Ability to think strategically, appropriately assess risks and formulate strategies to manage risk * Must demonstrate competencies in: * Building Relationships (works well across formal and informal networks) * Negotiation Skills (good listener; able to build a consensus) * Critical Information Seeking (works well across formal and informal networks) * Rational Persuasion (able to distil an issue to its key components and suggest solutions) * Interpersonal Awareness (aware of how actions affect other people) Preferred Background: * Experience in Labeling development and/or maintenance * Knowledge of major markets Labeling regulations * Advanced academic training is highly desirable (PharmD, PhD) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation

Posted On - 10/22/2014 7:18:50 AM

Labeling Manager

Macclesfield Cheshire

Key Relationships to reach solutions Internal and External Contacts/Customers: * GRLs/XRADs/RPMs * Patient Safety * Clinical * Regulatory personnel at the Marketing Companies * Operations * Commercial Education, Qualifications, Skills and Experience Minimum requirements: * University Degree in Science or related discipline * 3 years pharmaceutical experience, preferably regulatory experience, preferably working with labeling * Knowledge of labeling regulations and guidances * Excellent verbal and written communication skills * Keen attention to detail and accuracy * Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. * Ability to assimilate clinical and scientific information and present it in a concise manner * Ability to think strategically, appropriately assess risks and formulate strategies to manage risk * Must demonstrate competencies in: * Building Relationships (works well across formal and informal networks) * Negotiation Skills (good listener; able to build a consensus) * Critical Information Seeking (works well across formal and informal networks) * Rational Persuasion (able to distil an issue to its key components and suggest solutions) * Interpersonal Awareness (aware of how actions affect other people) Preferred Background: * Experience in Labeling development and/or maintenance * Knowledge of major markets Labeling regulations * Advanced academic training is highly desirable (PharmD, PhD) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation

Posted On - 10/22/2014 7:18:50 AM

Study Delivery Coordinator 12 Month Contract

Mississauga Ontario

Finance * Review, assess, approve and process payments associated with Clinical Study Agreements, ensuring accordance with the terms of the agreement and financial guidelines * Set up and maintaining the payment terms within the appropriate systems. * Review, analyze and resolving payment discrepancies and queries * Collation and execution of regular clinical cheque runs. Study Drug & Non- Drug Supplies * Manage non drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction * Provide drug label approvals. * Coordinate or execute import shipping approvals * Prepare and execute Statement of Work (SOW) with vendor for local drug management * Mange, coordinate and oversee the activities of the local drug management vendor ensuring accordance with the SOW. * Collaborate with Global Investigational Product Supplies units to ensure seamless delivery of clinical drug supplies * Collaborate and communicate with global study teams and local regulatory contacts, to assess Canadian requirements for comparator and/or rescue medication, and source from local providers if required * Review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors * Responsible for the notification, investigation and resolution of product quality complaints For Investigator Sponsored Studies / Fellowships / Funding Agreements: * Track and update recruitment in order to assess variance between planned and actual timelines for the study * Assess, review, report and manage financial variances between actual and planned spend across the budget. * Prepare, execute, track, collect, review and assess * Execute, track, collect, review and assess the documentation, required as per regulatory guidelines. * Manage (set-up / update / close) associated systems. * Manage (source / budget / procure) study supplies and investigational product Unspecified * University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered) * Two years experience in Clinical Research or related industry * Understanding of Good Clinical Practices/International Committee on Harmonization principles * Strong interpersonal and communication skills (written and oral). Especially need to be comfortable with speaking to Health Care Professionals. * Ability to influence without authority * Able to work effectively both independently and in a team environment. * Self-motivated and able to display autonomy and initiative ? for instance; able to take action, move actions forward and make decisions without the need for continual supervision or consultation. * Strong attention to detail * Ability to manage multiple demands/projects simultaneously * Effective time management skills * Solid Customer Service orientation * Good knowledge of MS Office (Word, Excel, PowerPoint) * Comfortable with technology and using multiple computer systems * French speaking considered an asset. Interviews: Only candidates who meet the minimum requirements as outlined above, will be interviewed. Internal candidates who are interested in this position must inform their manager before they apply.

Posted On - 10/22/2014 7:18:50 AM

Supervisors

Macclesfield Cheshire

Minimum Requirements - Education and Experience Essential: * Experience of FDA/cGMP or other regulated quality system. * Proven supervisory experience within manufacturing or support. * Understanding and application of Lean manufacturing principles. * Effectively problem solve. Desirable: * Degree (or similar) in a Science discipline. * Knowledge and application of Safety, Health and Environment principles. * Experience in formulation, filling or packaging. * Experience of sterile/aseptic operations. AstraZeneca welcomes applications from all sections of the community. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin, and will not be discriminated against on the basis of disability.

Posted On - 10/22/2014 7:18:50 AM

Senior Counsel-Data Privacy

Cambridge Cambridgeshire

All AZ global legal counsel are expected to develop their legal and leadership capabilities, including the flexibility and the ability to support legal work outside their core area of legal expertise. - Law degree. - Professional legal qualification. - Relevant legal practice experience. - Good interpersonal and communication skills. - Proven skills in analyzing and solving issues related to data privacy. Legal Experience requirements The Senior Counsel will be expected to have strong expertise in the following legal areas: - Data privacy laws and practice globally, and in the UK. - Data privacy elements of commercial contracts. - Freedom of Information legislation. - European Convention on Human Rights. - Clinical Trials Directive (preferred but not essential). - Pharmacovigilence legislation (preferred but not essential).

Posted On - 10/22/2014 7:18:50 AM

Architect: Innovation Project Leader/2 Year fixed-term/Cambridge/Luton

Cambridge Cambridgeshire

Relevant expertise and experience: - The ability to travel both domestically and internationally - Technical, Scientific or Business degree --- Master's degree preferred - Experience of Program Management methodologies with delivery in agile environments - Excellent communication, relationship management, and influencing skills - Proven track record negotiating & influencing across complex groups - Experience shaping innovative solutions - Experience working in global organization and across cultural boundaries - Coaching, facilitation & consultation skills

Posted On - 10/22/2014 7:18:49 AM

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