Göteborg: Senior Scientist - High-content imaging and assay development

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Publicerad: 2022-08-05 // Varaktighet: Heltid

Are you an experienced scientist in the field of high-content imaging and advanced analysis? Would you like to combine your scientific skills & curiosity to establish robust assays with human stem cell-derived in vitro models of disease and elucidate novel disease mechanisms? This might be the next challenge for you!

At AstraZeneca in Gothenburg, Sweden we have an exciting opportunity for you to join us in the Applied Stem Cell Sciences team in Translational Genomics, Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Senior Research Scientist to be a key player in developing high-content imaging based assays using advanced cell models.

The role

Working alongside our stem cell scientists, disease area specialists, genome editing group, and computational biology experts you will have the opportunity to work on scaleable cellular models in multiple indications to design and execute complex cell-based assays for target validation and mid-throughput screens for target identification.

The role is focused on laboratory-based activities. Your biggest impact will be through significant contributions to the practical delivery to projects in compliance with AstraZeneca corporate responsibility, policies and relevant safety standards.

It is essential to have good social and communication skills, be collaborative and a strong team player. Candidates should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude.

Good organizational, data management and documentation skills are required, and you should be comfortable in presenting your results. English language is required, both spoken and in writing.


Key Skills and Responsibilities:

* MSc/PhD degree with significant experience in Neuroscience or Cell Biology
* Minimum 3+ years experience in using automated (e.g. Yokogawa, Molecular Devices) and conventional fluorescent and confocal imaging systems (e.g. Zeiss, Nikon)
* Demonstrable skills across a broad range of image analysis and data analytics tools (Cell Profiler, ImageJ, Spotfire)
* Design and execute complex cell-based assays and mid-throughput screens using imaging-based readouts as well as other readouts as needed
* Troubleshoot batch effects, imaging protocol selection, cell- and compound-dispensing, data acquisition and instrument scheduling
* Collaborate effectively with Quantitative Biology and Machine Learning teams to optimize image analysis strategies, statistical analysis and model building

The following skills are highly desirable:

* Familiarity with human 2D and 3D cellular assays using primary or hiPSC-derived cells types.
* Experience with setting up cell-based pharmacological assays
* Familiarity with arrayed genetic screens including CRISPR-based approaches
* Experience with automated liquid handling systems (i.e., Bravo, Tecan, Hamilton or similar) and lab automation in context of cell-based screening

Why AstraZeneca?

Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. With more than 2,800 employees from over than 60 countries, our vibrant Gothenburg site is a truly inspiring place to work. Here, the history and future of scientific breakthrough come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.

So what's next? If this sounds like the next job and place for you, apply today!

We look forward to get to know you better - please send your application to us as soon as possible, but no later than 28th August, 2022.

For more information about the position please contact Bilada Bilican at bilada.bilican(at)astrazeneca.com.

Additional information:
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
Make a move to Global Gothenburg: https://www.youtube.com/watch?v=c-Iqbb4aw38
About BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

Alla platsannonser →

Andra jobb i Göteborg som Forskare, farmakologi

Nedan visas andra jobb i Göteborg som Forskare, farmakologi.

Scientist - Early Product Development and Manufacturing

Läs mer Jul 1
At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science!

Pharmaceutical Sciences (PharmSci) is responsible for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca's therapeutic areas.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing unit is accountable for delivering a vast portfolio of early investigational medicinal products. We have a wide range of manufacturing assets in three separate manufacturing facilities, supplying different types of clinical trial material to studies across the globe.



The role

We are now seeking a new member to join our fantastic team, based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work. Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results in the development of new medicines.

This role revolves around the manufacturing of drug product where all activities below will have a significant impact on the speed, quality and cost of the AZ development portfolio.



What you'll do

Working in the role as Scientist in EPDM and PharmSci, you will be part of an amazing group of skilled and driven colleagues who truly embrace team spirit, who you will exchange knowledge and collaborate with on many levels in various contexts. This role provides excellent opportunities for your professional development, and possibilities to take on further accountabilities in line with your personal growth.



Your main accountabilities/responsibilities:

*

Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
*

Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
*

Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
*

Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
*

Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
*

Assess records and report manufacturing and validation data accurately according to GMP.
*

Ensure that SHE (Safety Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
*

Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for our customers and patients.



Do you have the essential qualifications for these roles?

To be successful in this role, we believe that you have a MSc in pharmacy/engineering and/or extensive GMP-manufacturing experience from the pharmaceutical industry.

We are looking for a scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, teamwork and delivery focus. There is both scope and an expectation to build the range of accountabilities over time, in line with personal development.

Strong verbal and documentation skills in English is a requirement. We expect you to have a keen interest to learn and operate complex manufacturing equipment and develop your expertise in pharmaceutical process technology. Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is a merit for this role.



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you!

Welcome with your application (CV and cover letter) no later than August 19th. NOTE - Due to our summer vacation period in Sweden during July-August, the screening process may take a bit longer than usual. Thanks for your understanding and we will get back to you as soon as possible when we are back at work. Interviews will be held late August.

Ansök nu

Clinical Pharmacology Expert in CVRM

Läs mer Jul 29
Do you have expertise and experience in clinical pharmacology, PK, PKPD, Model Informed Drug Development (MIDD) and its application in drug development? Would you like to apply your expertise in a company that is following the science and turn ideas into life changing medicines? If yes, we have the position for you at AstraZeneca!

We now have an exciting opportunity for an engaged and diligent individual to join our growing Clinical Pharmacology and Quantitative Pharmacology (CPQP) team at AstraZeneca at our vibrant Gothenburg site in Sweden, as a Senior Scientist, Associate Director or Director depending on your background, experience and skills.

This is a global role that will support large- and small molecule projects across all phases of clinical development within the therapy area of Cardiovascular, Renal and Metabolism.

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Within the Clinical Pharmacology and Safety Sciences (CPSS) function at AstraZeneca, we have a state-of-the-art Clinical Pharmacology and Quantitative Pharmacology (CPQP) organization with a diverse and uniquely skilled team of clinical pharmacometricians, clinical pharmacology scientists and other experts. You will thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Gothenburg is a key research and development location for our Cardiovascular, Renal and Metabolism area.

What you will do

Working closely with clinical pharmacometricians, physicians and other scientists, you will apply your expertise and leadership skills to contribute to the strategy of the clinical development program and the design and interpretation of clinical studies. You will influence key decisions in early and late phases of clinical development.

In collaboration with clinical pharmacometricians, you will represent CPQP in cross-functional project teams, and be responsible for developing the clinical pharmacology strategy. The work includes integration of relevant data, such as dose information, pharmacokinetics, biomarkers and clinical endpoints within and across studies, compounds and development stages. You will take part in finding opportunities to apply model informed drug development to accelerate and advise decision making. Based on your interest, skills and experience, you might also perform some pharmacokinetic and pharmacometrics modelling and simulation acting as a dual Clinical Pharmacometrician/Clinical Pharmacologist. You will communicate your findings within and outside of AstraZeneca and publish in peer reviewed journals.

Minimum requirements for the role

* PhD or equivalent (M.Sc/Pharm.D.) in clinical pharmacology or other relevant area
* Good knowledge of pharmacokinetics, PKPD and Clinical Pharmacology
* Biological understanding of disease and drug action
* Good oral and written communication skills

Desirable in the role

* 3+ years of industry experience or equivalent in pharmacokinetics and clinical pharmacology in drug development
* Track record in creating and delivering on clinical pharmacology strategies of both small and large molecules
* Early and late phase clinical development experience
* Good knowledge and experience in use of PK and PKPD modelling and its clinical application
* Recognized clinical pharmacology expertise as demonstrated by scientific publishing in the field of clinical pharmacology

We truly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution. You have a real passion for your subject, along with a collaborative nature and ability to work in multi-disciplinary global teams.

Why AstraZeneca?

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Collaborate in an inclusive environment, a place full of bold new opportunities. Be empowered to be innovative and creative where difference is valued.


So, what's next! Does this sound like your next challenge? Apply today!

We look forward to find out more about you. Send in your application as soon as possible, we will review applications continuously.

For more information about the position please contact the hiring managers, Angelica Quartino (https://www.linkedin.com/in/angelica-quartino-352a7b2/) or Ann-Charlotte Egnell (https://www.linkedin.com/in/lotta-egnell-9595b0a/)

Where can I find out more?

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg site: https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/goteborg/relocate-to-gothenburg.html
Read more about BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

#DataAI

Ansök nu

Clinical Pharmacometrician in CVRM

Läs mer Jul 29
Do you have expertise and experience in PK and PKPD, mathematical/statistical modelling and simulation, Model Informed Drug Development (MIDD) and its application in drug development? Would you like to apply your knowledge in a company that is following the science and turn ideas into life changing medicines? Then this might be your next challenge!

We now have an exciting opportunity for an engaged and diligent individual to join our growing Clinical Pharmacology and Quantitative Pharmacology (CPQP) team at AstraZeneca at our vibrant Gothenburg site in Sweden, as a Senior Scientist, Associate Director or Director depending on your background, experience and skills.

This is a global role that will support large- and small molecule projects across all phases of clinical development within the therapy area of Cardiovascular, Renal and Metabolism.

Within the Clinical Pharmacology and Safety Sciences (CPSS) function at AstraZeneca, we have a state-of-the-art Clinical Pharmacology and Quantitative Pharmacology (CPQP) organization with a diverse and uniquely skilled team of clinical pharmacometricians and clinical pharmacology scientists. You will thrive in an environment that inspires innovation, encourages multidisciplinary team-working and collaboration with academia, and rewards original scientific thinking.

What you will do
Working closely with clinical pharmacologists, physicians, statisticians and other scientists, you will apply model informed drug development (MIDD) to contribute to clinical programs, to support the design and interpretation of clinical studies and influence key decisions in early and late clinical development.

The work includes integration of relevant data, such as dose information, pharmacokinetics, biomarkers and clinical endpoints within and across studies, compounds and development stages. Use of simulations and pharmacometric/statistical analyses to inform trial and program designs and decisions are important focus areas for us.

In collaboration with clinical pharmacologists, you will represent CPQP in cross-functional clinical project teams and be responsible for identifying and executing model informed drug development opportunities, to accelerate and inform decision making. Based on your interest, skills and experience, you might also take on strategic planning and delivery of the clinical pharmacology strategy acting as a dual Clinical Pharmacometrician/Clinical Pharmacologist. You will communicate your findings within and outside of AstraZeneca and publish in peer reviewed journals.

Minimum requirements for the role

* PhD or equivalent (M.Sc. or Pharm.D.) in pharmacometrics or mathematical/statistical modeling and simulation or other relevant area
* Strong technical knowledge and hands-on skills in modeling and simulation
* Biological understanding of disease and drug action
* Good oral and written communication skills

Desirable in the role

* 3+ years of industry experience or equivalent in quantitative modelling and its application in drug development
* Track record in creating and delivering on MIDD strategies in clinical drug development programs for both small and large molecules
* Early and late phase clinical development experience
* Understanding of clinical pharmacology aspects of drug development, preferably in both a small and large molecule setting
* Recognized scientific expertise demonstrated by scientific publishing in the field of clinical pharmacology

We truly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution. You have a real passion for your subject, along with a collaborative nature and ability to work in multi-disciplinary global teams.

Why AstraZeneca?

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Collaborate in an inclusive environment, a place full of bold new opportunities. Be empowered to be innovative and creative where difference is valued.

So, what's next? If the sounds like the job and place for you - apply today!

We look forward to find out more about you. Send in your application as soon as possible, we will review applications continuously.


For more information about the position please contact the hiring managers, Angelica Quartino (https://www.linkedin.com/in/angelica-quartino-352a7b2/) or Ann-Charlotte Egnell (https://www.linkedin.com/in/lotta-egnell-9595b0a/)

Where can I find out more?

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg site: https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/goteborg/relocate-to-gothenburg.html
Read more about BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

#DataAI

Ansök nu

Senior Medical Communication Manager

Läs mer Jul 21
We are looking for strategically-minded innovative individuals with strong clinical, collaboration, and organizational skills to join our Global Medical Information team at the vibrant site in Gothenburg, Sweden.

Exciting opportunity to work in a team that has a broad scope of work in the medical information and medical communication space. We are always innovating and striving for excellence in medical communications to help improving patients' lives.

What you'll do

Medical information at AstraZeneca is responsible for the strategic planning, development and implementation of medical content and communication for health care professionals using various channels, including digital, to support patient care. A combination of global and US remits provides the opportunity to collaborate internationally and drive strategically-aligned and consistent medical communication.

The Senior Medical Information Manager is responsible for the proactive planning, development of scientific content to support Medical Affairs, providing scientific consult, review & approval of promotional materials, and answering medical inquiries from healthcare professionals to bring value to our customers and ultimately the patient. Additionally, this role empowers forward-thinking and digital innovation to help drive efficiencies and engaging scientific exchange.

Responsibilities

General

*

Strategic application of scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape
*

Collaborate with key collaborators to strategically plan and implement scientific information development and dissemination to meet customer needs
*

Supervise the medical environment and apply expertise, coordinated with regulatory/compliance landscape, and local markets' knowledge to impact Brand/Therapeutic Area strategy
*

Contribute to processes related to MI operations, drive operational excellence, and support digital innovation through forward and innovative thinking to meet business needs efficiently

Scientific Content/Brand Partnership

*

Strategically lead and/or provide oversight of others in the development, review and maintenance of communication materials for various channels (e.g., MI requests, digital, Field Medical) in collaboration with Medical Affairs for global and US market
*

Represents Medical Information within the promotional review cross functional team by:
*

Providing strategic scientific consults on brand messages
*

Reviewing promotional materials for content, accuracy, and final MI approval
*

Collaborating across the business to ensure promotional and non-promotional materials are strategically aligned
*

Provides guidance for the use of AZ products by reviewing resources developed by external compendia (e.g. evidence-based practice centres, treatment guidelines, Medical Letter)

Customer Engagement

*

Provides oversight of others and/or responds to medical information inquiries from Health Care Providers via multiple channels
*

Delivers accurate, focused, and scientifically balanced clinical and scientific information exchange with healthcare providers that support the appropriate use of AstraZeneca products.
*

Identify, analyse and report trends in medical and scientific insight (including medical inquiries) to Medical Affairs partners and assess the need to update or build scientific materials (standard responses, slide decks, and Q&As;).

Essential

*

Post graduate qualification in medical/scientific field (e.g., PharmD, MD, PhD, MPharm or equivalent)
*

Drug/medical information experience gained in pharmaceutical industry or comparable experience with the healthcare/clinical/hospital environment
*

Experience in scientific literature evaluation and analysis
*

Experience in medical writing
*

Strategic problem solver with eye for business (optimally influence and interact with cross-functional colleagues) and organizational skills

Desirable

*

Promotional medical review experience
*

Medical communications/content creation (e.g., slide decks) experience
*

Digital strategy oriented attitude and experience
*

Project management experienc
*

Experience in applying regulatory (e.g. FDA, EMA), legal, and compliance requirements to Medical Affairs activities and drug information delivery



Why AstraZeneca

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So, what's next?

Welcome with your application no later than August 22nd.



Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Ansök nu

Andra jobb i Göteborg från Astrazeneca AB

Nedan visas andra jobb i Göteborg från Astrazeneca AB .

Scientist - Early Product Development and Manufacturing

Forskare, farmakologi
Läs mer Jul 1
At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science!

Pharmaceutical Sciences (PharmSci) is responsible for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca's therapeutic areas.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing unit is accountable for delivering a vast portfolio of early investigational medicinal products. We have a wide range of manufacturing assets in three separate manufacturing facilities, supplying different types of clinical trial material to studies across the globe.



The role

We are now seeking a new member to join our fantastic team, based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work. Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results in the development of new medicines.

This role revolves around the manufacturing of drug product where all activities below will have a significant impact on the speed, quality and cost of the AZ development portfolio.



What you'll do

Working in the role as Scientist in EPDM and PharmSci, you will be part of an amazing group of skilled and driven colleagues who truly embrace team spirit, who you will exchange knowledge and collaborate with on many levels in various contexts. This role provides excellent opportunities for your professional development, and possibilities to take on further accountabilities in line with your personal growth.



Your main accountabilities/responsibilities:

*

Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
*

Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
*

Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
*

Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
*

Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
*

Assess records and report manufacturing and validation data accurately according to GMP.
*

Ensure that SHE (Safety Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
*

Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for our customers and patients.



Do you have the essential qualifications for these roles?

To be successful in this role, we believe that you have a MSc in pharmacy/engineering and/or extensive GMP-manufacturing experience from the pharmaceutical industry.

We are looking for a scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, teamwork and delivery focus. There is both scope and an expectation to build the range of accountabilities over time, in line with personal development.

Strong verbal and documentation skills in English is a requirement. We expect you to have a keen interest to learn and operate complex manufacturing equipment and develop your expertise in pharmaceutical process technology. Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is a merit for this role.



So, what's next?

Are you already imagining yourself joining us? Good, because we can't wait to hear from you!

Welcome with your application (CV and cover letter) no later than August 19th. NOTE - Due to our summer vacation period in Sweden during July-August, the screening process may take a bit longer than usual. Thanks for your understanding and we will get back to you as soon as possible when we are back at work. Interviews will be held late August.

Ansök nu

Business Analyst

Systemanalytiker/Systemutredare
Läs mer Aug 4
Business Analyst - Gothenburg



About the role

AstraZeneca is investing heavily in our Augmented Drug Design-Make-Test and Analyse platforms as we seek to deliver better, differentiated Candidate Drugs into trials, faster, for greater patient benefit. We have made great strides in creating the data analytics, AI, and ML services that will pave the way for this transformation. The next part of this journey will involve leveraging the current services to build new applications that will enable our scientists to design new and safer drugs faster.



We are now looking for a Business Analyst to join the team. The role will partner with the Business Relationship Manager or Business Analyst colleagues to support the development of business cases, assist in business process design and ensure that proposed solutions meet established AstraZeneca quality and compliance standards and business solution needs. Your work will have a direct impact on the science we do, and you have an opportunity to enable our scientists to undertake science not possible today.



Accountabilities

* Business Needs Identification - Operate at a functional level in assessing and defining business needs and areas for improvement. Proactively seek out opportunities to enhance and improve in line with strategic goals.
* Business Analysis Planning - Select the appropriate analysis approach to a piece of work depending on its complexity, level of risk, known assumptions, constraints and dependencies.
* Partner Analysis & Change - Identify collaborators, build and manage relationships according to individual stakeholder needs and levels of influence. Contribute to communication plans.
* Requirements Analysis and Design Definition - Responsible for requirements management plans including elicitation, approvals, processes, RAID and scope impacts.
* Business Case and Benefits Management - Support the business case definition, collect business justification for investment including return on investment and benefits realisation.
* Solution Evaluation - Analyzes and assesses solution proposals and able to articulate supporting reasoning. i.e. assessing business readiness, improving value vs. spend.
* Test Lead to define the testing approach and the components of testing to ensure traceability of requirements and efficiency of overall solution.
* Change/Communication Lead to ensure that plans and delivery support the Partner Analysis.



Requirements

To succeed, you have experience working in a regulated environment, performing business analysis and design, either alone delivering small scale business change activities; or as a contributor to a large scale or global business change. You are a communicator with strong engagement, facilitation and presentation skills, with an ability to influence others. It is important that you operate with interactive communication, demonstrating inclusion and cultural sensitivity.



We also see that you have:

* Practical usage of Agile Methodology (Scrum/Kanban)
* Jira / Confluence or similar tools
* Experience of working with third party suppliers/vendors
* Focus on customer care
* Ability to work with multiple collaborators
* Experience with planning, compliance, Business Process & Requirements Management



Pharmaceutical business domain knowledge is desireable, however not essential.



About AstraZeneca

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

SO, WHAT NEXT?

Are you up for an exciting challenge and ready for making a difference? If so, hit Apply by the 1st of September - we can't wait to hear from you!



Open date: 4/8/2022

Close date: 1/9/2022

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Director, Global Regulatory Affairs CVRM

Biolog
Läs mer Jul 5
Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio!

AstraZeneca's pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM). Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it - working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people - providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.

We are more than 65.000 people in over 100 countries. Our aim is simple to positively impact lives together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments.

We continue to expand our regulatory teams at AstraZeneca's dynamic R&D sites in Gaithersburg (US), Cambridge (UK) and Gothenburg (Sweden). If you are looking for a new challenge, we are offering opportunities in different disease areas and at different levels, depending on your expertise and previous experience.



What You'll do

As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.

Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.



Essential for the role

In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization.

*

Academic degree in a science related field or equivalent
*

Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development
*

Proven track record of regulatory drug development including product approval/launch.
*

Experience in leading Major Health Authority interactions
*

Ability to think strategically and critically and evaluate risks to regulatory activities.
*

Ability to work strategically within a complex, business critical and high-profile development program.



At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.



We are eager to know more about you. If you are interested to know more about us, apply now! We welcome your CV and cover letter no later than August 31, 2022.



Additional information

Curious about Regulatory at AstraZeneca?

More information about our sites:

* Cambridge, UK
* Gothenburg, Sweden
* Gaithersburg, US

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Senior Regulatory Affairs Director, Vaccines & Immune Therapies

Biolog
Läs mer Aug 9
Nytt
Are you a strategically focused Regulatory Affairs professional and would like to play an integral part in shaping drug development and gaining fast, efficient regulatory approvals? If so, read on...

At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover. The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms. Within V&I Regulatory Science and Strategy, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Senior Regulatory Affairs Director (SRAD) is accountable for the development and implementation of the global regulatory strategy for a product/group of products within the V&I portfolio. The SRAD must possess strategic leadership skills and have a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs. You will provide team leadership and participate in coaching and mentorship to members of the Global Regulatory Strategy Team. You will be viewed as a senior leader within the regulatory community.





What you'll do…

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Accountable for the development and implementation of innovative global strategies of increasing complexity, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
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Accountable for product maintenance, supply and compliance activities associated with marketed brands
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Deliver all regulatory milestones, including the assessment of the probability of regulatory success, with risk analysis and mitigation
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Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities
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Lead the development of the global regulatory strategy document for assigned products/projects and the planning and construction of the global dossier and core prescribing information
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Provide regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
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Participate in and promote novel regulatory initiatives internally and engage externally on corresponding topics as needed



Essential requirements

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Bachelor's degree in a life science or related discipline
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Substantial direct experience of working as the interface with regulatory authorities and leading delivery of regulatory projects through key milestones and investment decisions
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Broad background of experience working in several areas within regulatory affairs or therapy areas, including early and late-stage development
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Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment



Desirable requirements

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Previous experience in vaccines or immune therapies is strongly preferred
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Advanced degree in science related field and/or other appropriate knowledge/experience
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Previous experience with major regulatory authority meetings in multiple regions
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Previous experience working on due diligence activities and in a business alliance environment



Locations: Cambridge, United Kingdom; Gothenburg, Sweden, Södertälje, Sweden.



?Salary: Competitive + Excellent Benefits



So, what's next?

Are you already imagining joining our team of Global Clinical Heads? Good, because we can't wait to hear from you! Welcome with your application no later than August 31.



More information about our sites:

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Cambridge UK
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Gothenburg SE





Why AstraZeneca?

AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There's no better place to see what science can do.

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Associate Director, Project Information

IT-strateg
Läs mer Jul 15
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and teamwork. Always committed to lifelong learning, growth and development!

The Associate Director, Project Information provides consultative advice to users of the system to ensure that the information required by the business (activities, cost, and value) is available for decision making at the project and portfolio level. This role is accountable of providing suave project management systems expertise in the drug development project planning process and the PLANIT tool set (Planisware and reporting). You will be responsible for coaching and training the Global Project Managers, Functional Project Managers and GPPM-led project teams in program and project management techniques available within the PLANIT tool set to facilitate the delivery of project objectives.

The working environment is fast paced and to be successful in the role you have previously worked on multi-functional teams and can easily adapt your way of communicating with different stakeholders to build relationships. You have a solid understanding of the Drug Development Process and its different stages and functions.

Major Duties and Responsibilities

* Identification of process/tool issues and recommended solutions
* Development and management of PLANIT Business Processes
* Monthly Reference Line Process
* Project Base-lining
* Portfolio and Business Update Review Process
* Business requirement collection of changes required to the system based on organizational or continuous improvement efforts, e.g.:
* Managing changes e.g. Organizational changes (RBS), PLANIT template changes, Algorithm changes, data quality, training users etc.
* Ad Hoc PLANIT consultancy when Global Project Managers and Functional Project Managers need advice on how to complete a task within the PLANIT system or through a PLANIT process related to their project

Requirements/Qualifications:

System software/Portfolio Management

* Knowledge of project management as a subject area including the ability to build, coordinate, and maintain an integrated product plan and to control or respond to changes in strategy and scope.
* Expertise in use of enterprise-wide pharmaceutical project management software solutions, including skills in critical path analysis. MS Project and/or Planisware experience is required in a Pharmaceutical/Biotech environment.
* General understanding of financial and resource planning systems and processes and ability to coordinate project-level budget/resource estimates and lead actuals vs. plan.
* Experience with reporting software such as PowerBI and Business Objects is a plus.
* A level of knowledge/awareness of the overall biologic/pharmaceutical product development process, including stages of development and role of different functional areas.
* Working in multi-functional teams

Other Experience/Abilities

* Must be professional, dedicated, and detail-orientated and have the flexibility to travel domestically and internationally.
* Excellent oral and written communication, interpersonal, analytical, and digital literacy.
* Demonstrated organizational skills required, including good time management skills and the willingness to work independently.

Leadership Capabilities Required

* Commitment to Customers & Integrity
* Focuses on what is important: balances and prioritizes across diverse and competing customers, needs and opportunities. Demonstrates the courage to make tough decisions about where to invest time and energy
* Acts Decisively
* Takes calculated risk: makes effective decisions despite uncertainty and/or incomplete information to drive business outcomes. Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriately
* Works Collaboratively
* Encourages Diverse Thinking: creates an environment in which diverse viewpoints are sought and encouraged both within and beyond the team
* Drives Accountability
* Holds others accountable: Communicates clear expectations of behavior and outcomes as well as why these standards matter. Holds others accountable for delivering them

This is a phenomenal opportunity to contribute to advances within the area of Project Information and systems! Role can be adapted depending on seniority of applicant.

Welcome with your application, no later than August 21, 2022.



Additional information:

Our site in Gothenburg: https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/goteborg.html

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Clinical Pharmacology Expert in CVRM

Forskare, farmakologi
Läs mer Jul 29
Do you have expertise and experience in clinical pharmacology, PK, PKPD, Model Informed Drug Development (MIDD) and its application in drug development? Would you like to apply your expertise in a company that is following the science and turn ideas into life changing medicines? If yes, we have the position for you at AstraZeneca!

We now have an exciting opportunity for an engaged and diligent individual to join our growing Clinical Pharmacology and Quantitative Pharmacology (CPQP) team at AstraZeneca at our vibrant Gothenburg site in Sweden, as a Senior Scientist, Associate Director or Director depending on your background, experience and skills.

This is a global role that will support large- and small molecule projects across all phases of clinical development within the therapy area of Cardiovascular, Renal and Metabolism.

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Within the Clinical Pharmacology and Safety Sciences (CPSS) function at AstraZeneca, we have a state-of-the-art Clinical Pharmacology and Quantitative Pharmacology (CPQP) organization with a diverse and uniquely skilled team of clinical pharmacometricians, clinical pharmacology scientists and other experts. You will thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Gothenburg is a key research and development location for our Cardiovascular, Renal and Metabolism area.

What you will do

Working closely with clinical pharmacometricians, physicians and other scientists, you will apply your expertise and leadership skills to contribute to the strategy of the clinical development program and the design and interpretation of clinical studies. You will influence key decisions in early and late phases of clinical development.

In collaboration with clinical pharmacometricians, you will represent CPQP in cross-functional project teams, and be responsible for developing the clinical pharmacology strategy. The work includes integration of relevant data, such as dose information, pharmacokinetics, biomarkers and clinical endpoints within and across studies, compounds and development stages. You will take part in finding opportunities to apply model informed drug development to accelerate and advise decision making. Based on your interest, skills and experience, you might also perform some pharmacokinetic and pharmacometrics modelling and simulation acting as a dual Clinical Pharmacometrician/Clinical Pharmacologist. You will communicate your findings within and outside of AstraZeneca and publish in peer reviewed journals.

Minimum requirements for the role

* PhD or equivalent (M.Sc/Pharm.D.) in clinical pharmacology or other relevant area
* Good knowledge of pharmacokinetics, PKPD and Clinical Pharmacology
* Biological understanding of disease and drug action
* Good oral and written communication skills

Desirable in the role

* 3+ years of industry experience or equivalent in pharmacokinetics and clinical pharmacology in drug development
* Track record in creating and delivering on clinical pharmacology strategies of both small and large molecules
* Early and late phase clinical development experience
* Good knowledge and experience in use of PK and PKPD modelling and its clinical application
* Recognized clinical pharmacology expertise as demonstrated by scientific publishing in the field of clinical pharmacology

We truly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution. You have a real passion for your subject, along with a collaborative nature and ability to work in multi-disciplinary global teams.

Why AstraZeneca?

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. Collaborate in an inclusive environment, a place full of bold new opportunities. Be empowered to be innovative and creative where difference is valued.


So, what's next! Does this sound like your next challenge? Apply today!

We look forward to find out more about you. Send in your application as soon as possible, we will review applications continuously.

For more information about the position please contact the hiring managers, Angelica Quartino (https://www.linkedin.com/in/angelica-quartino-352a7b2/) or Ann-Charlotte Egnell (https://www.linkedin.com/in/lotta-egnell-9595b0a/)

Where can I find out more?

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg site: https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/goteborg/relocate-to-gothenburg.html
Read more about BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html

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