Lediga jobb som Biomedicinare i Mölndal

Do you have a scientific or clinical background combined with an entrepreneurial attitude and business know-how? Would you like to apply your expertise in a company where we are following the science and turn ideas into life changing medicines? Then you might be the one we are looking for!
Join the Search and Evaluation Department within Business Development and Licensing, Biopharmaceutical R&D with focus on CVRM in Gothenburg, Sweden.

Job description
The Search and Evaluation Director, Cardiovascular, Renal and Metabolism, in Business Development and Licensing is a key role in Biopharmaceuticals R&D, AstraZeneca.
You will support global Business Development initiatives and have a direct impact on the scientific strategy and portfolio.
The Search and Evaluation (S&E) group drives search efforts of external innovation throughout the Biopharma R&D community and conducts technical due diligence activities that ensure an in-depth understanding of investment opportunities and provides decision-making tools for the organization.

Who are you?
You have a strong R&D scientific and / or clinical background, business acumen and excellent communication skills as well as an ability to engage and collaborate across boundaries with an entrepreneurial attitude and delivery focus.

Major Duties and Responsibilities:
Reporting to the Head of S&E, CVRM, you will be responsible for identifying and evaluating external in-licensing opportunities from academia, biotech’s and peer-pharma including early research projects, new modality platforms, early and late clinical stage candidates and Life Cycle Management (LCM) opportunities
You will be responsible for representing the Business Development strategy at partnering meetings to identify exernal assets and opportunities.
You will integrate input from various functional areas across the organization to create high quality, clear and concise confidential evaluation reports of external assets and will provide recommendations to Head of S&E.
You will identify and evaluate key strategic collaborations and technical platform capabilities that can enhance the scientific credibility and portfolio of Biopharmaceuticals R&D CVRM.
You will works constructively with key stakeholders and cross-functional teams including commercial to ensure effective communication, efficient decision-making, to support completion of transactions with BD teams in a timely manner
You will track breakthrough innovation, ongoing clinical trials and market trends of existing external CVRM opportunities using competitive intelligence tools to identify opportunities, threats and risks in a timely manner.

Culture:
A dynamic, entrepreneurial and externally facing organization which enables an internally and externally collaborative culture with calculated risk taking.
Collaborate closely with colleagues in CVRM and BD teams, and across business to identify and exploit cross-business opportunities and embed best practice.



Education:
Advanced Degree Required (MD or PhD or PharmD).



Requirements and Qualifications:
Strong scientific reputation in drug discovery and clinical development
Basic understanding of deal making
Ability to interact and communicate effectively
Proven leadership abilities in a R & D environment
A strong understanding of clinical development experience in CVRM , demonstrating cultural sensitivity and awareness.
Extensive experience in pharmaceutical R&D, demonstrating international experience in multiple cultures and R & D environments.
Ability to think critically, creatively and to anticipate and solve problems
Ability to navigate and be successful in a fast-paced, highly-matrixed work environment



Leadership and Behaviours:
Excellent communicator who take responsibility for decisions made. Role model engagement and commitment.
Able to lead culture shift and raise the bar in performance at all levels in the organization
Able and accountable for driving business performance.
Understand the wider AstraZeneca business priorities
Appreciate that scientific expertise needs to be balanced with business leadership
Able to actively seek collaboration in a complex matrix structure



Apply with your CV and Cover letter no later than May 21st, 2025 Visa mindre

Ribocure Pharmaceuticals AB (Ribocure) is an international R&D center focusing on oligonucleotide drug development. We are based in Gothenburg as a subsidiary of Suzhou Ribo Life Science Co., Ltd. (Ribo). Recently, we moved into our new amazing custom designed floor at GoCo Clinic, GoCo Health Innovation City in Mölndal.

We offer a vibrant collaborative and international environment where science and data are the main driving forces behind our ambition to develop game-changing medical treatments for patients. We are now looking for a biomedical technician to join the team.

This is an exciting opportunity to join the dynamic research team at Ribocure Pharmaceuticals AB. This role within the clinical team has been developed in response to the evolving research landscape with focus on excellent quality in clinical trials. You will be part of an innovative team responding to national and international priorities.

As part of the research team, you will be involved in studies across a wide range of specialties, increasing recruitment to clinical trials and growing the research portfolio into new clinical areas. You will partake in conducting in-house trials at Ribocure Clinic.



What we offer
A dynamic and stimulating scientific work environment in an integrated R&D and clinical trial unit at GoCo Clinic, Mölndal. This is initially a probation assignment of 6 months with the opportunity for later permanent employment at Ribocure.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Main duties of the job
The successful candidate will join an enthusiastic team also consisting of study nurses and study physicians. Overall duties consist of performing trial examinations, data acquisition and data entry at Ribocure Clinic. Performing measurements and maintain a research database is fundamental. Further, you will contribute in the team to tasks such as participant identification, recruitment, and follow-up in addition to any study specific procedures. A key part of the role will be to collaborate with all members of the team and therefore you must possess excellent organizational, interpersonal and communication skills and demonstrate good attention to detail.

Working for our organization
We are a friendly proactive team that support and grow its team members. Based at GoCo, Ribocure Clinic has a clear vision to become a high-volume center with excellent clinical trial quality.

Detailed job description and main responsibilities
Research experience would be advantageous but not essential, as all necessary training and support will be provided. The position will provide exciting opportunity for working across multiple medical specialties (cardiology, internal medicine, clinical physiology, and other clinical areas).

- Performing cardiovascular ultrasound scans and measurements according to specific protocols

- Performing cardiopulmonary exercise tests according to specific protocols

- Conduct documentation and reporting of the examinations

- Conduct measurements and perform exports of data

- Assist in writing manuals for data collections and coding

- Take a leading part of activities associated with data processing

- When necessary, perform venipuncture for research blood collection and blood sample handlingsisting in the coordination, development, and application of research techniques

- Database management

- Patient/trial participant identification, recruitment, and follow-up in addition to any study specific procedures

- Have effective time management and the ability to work under limited supervision

- Be able to integrate with other teams to achieve set objectives

- Be conversant with Good Clinical Practice (GCP)

- Be proficient with Microsoft Office applications (Word, Excel, Access etc)

Person specification
Education, Qualifications, Experience & Training
Essential criteria

- Be a licensed biomedical technician

- Have previous clinical experience from relevant areas (cardiology, internal medicine, clinical physiology or other)

- Be computer litterate

- Be fluent in Swedish

Desirable criteria
- Experience of education and training

- Experience in developing instructions

- Willingness to work flexibly in terms of duties to meet service needs

- Previous practical experience of clinical trials/research will be an asset but not a requirement

Skills, Knowledge & Abilities
Essential criteria
- Understanding of research methods

- Be able to perform cardiac and vascular ultrasound

- Be able to perform venipuncture

- Ability to self-manage

- Good communication and inter-personal skills

- Demonstrable commitment to personal and professional development

- Good presentation skills

- Able to work individually or as a team player

- Attention to detail

- Ability to work flexible in terms of duties

- Clear understanding of confidentiality issues - knowledge of GDPR

- Ability to use own judgment based on information available and to seek advice when unsure of appropriate response

- Ability to manage projects with limited supervision

Desirable criteria
- Be able to perform cardiopulmonary exercise test

- Ability to work occasional weekend/out of hours work as requiredAbility to travel across the VGR-area for home visits if needed

Other
Essential criteria
- Strong commitment to clinical research

- Excellent timekeeping and a flexible approach to workGood attendance record in previous posts or during training

Please apply as soon as possible by pressing Send Application.

If you have questions, please contact Dr Sara Svedlund (mailto: [email protected]).

Welcome to Ribocure!

This recruitment is quality assured by HR On Demand. Visa mindre

Heres a chance to join our dynamic team at Ribocure Pharmaceuticals AB as an SML, where you will contribute in Ribocures mission to build a world-leading RNA therapeutics R&D company in Sweden and help patients all over the world. We are dedicated to developing innovative treatments that make a difference in patients' lives. At Ribocure, we foster a culture of excellence and are committed to the highest standards of quality in everything we do.
We are now searching fora highly motivated colleague to join our Clinical Sample Management Team.
About the Job
As ourSample Management Lead you will playa coordinating role in a cross-functional setting. The responsibilities cover the entire life cycle of our clinical samples, from protocol development to sample analysis and destruction, including laboratory vendor selection and contracting.
The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations
Key Responsibilities of the Position1. Laboratory Vendor Selection and Contract Management Lead the identification, selection, and contracting of appropriate laboratories for Pharmacokinetic- (PK), Pharmacodynamic- (PD) and Anti-Drug Antibodies (ADA) analysis.
Collaborate closely with the Clinical Operations Trial Lead and cross-functional experts from various departments like Bioanalysis, Pharmacology, Medical, Translational Science and Clinical Pharmacology to ensure that selected laboratories and assays meet scientific and regulatory requirements.
2. Contribute to Clinical Trial Protocol development and support Regulatory and Ethical Committee submissions Ensure sample collection time points are cost efficient and patient/site centric in regards of blood volumes collected and operational aspects from a site perspective.
Review of trial participant information and the Informed Consent Form.
Responsible for Biobank applications, when applicable.
3. Clinical Sample Management and Lab Kit Supply Coordination Ensure accurate lab kit development and site supply, as well as lab manual development/review.
Training of site staff and CRAs at Site Initiation Visits and continuous support throughout the trial.
Responsible for clinical trial-level sample management, ensuring that samples are delivered from the right patients to the laboratory at the right time.
Ensure Data Transfer Agreements are in place.
4. Data Tracking Oversight and Issue Resolution Coordination Work closely with Clinical Operations, Clinical Pharmacology/Modeling, Medical and selected vendors to ensure critical data is available, analyzed and transferred in a timely manner.
First point of contact and coordinating troubleshooting of PK, ADA and PD sample analysis and assay issues, and proactively anticipating and mitigating potential problems.
5. Communication and Process Improvement Proactively communicate updates and timelines to stakeholders, provide advice and guidance on the sample management process
Collaborate with preferred vendors and quality assurance personnel to develop improvements in the sample management process.
6. Biobank Support the Ribocure Biobank manager in biobank related activities, such as handling of clinical samples, drafting Material Transfer Agreements and assisting in the annual quality control.
Essential Requirements
You must live in the proximity of Gothenburg, Sweden, to be qualified for this position.
University degree, preferably in pharmaceutical sciences, pharmacology, biomedical engineering, biochemistry, biological science, or discipline associated with medicine or clinical research
Minimum of 3 years’ experience in the pharmaceutical or biotech industry
Hands on experience and/or technical knowledge related to different methods and assays used for analyzing PK, ADA, PD and biomarkers (particularly different ELISA techniques, MSD and LC-MS)
Strong competence in English communication, both in writing and speaking
Ability to work independently as well as in a cross-functional setting
Proven ability to coordinate effectively and manage multiple tasks simultaneously in a fast-paced and dynamic work environment
Desirable Requirements Experience of working in a global context where you appreciate and understandcultural differences
Experience in clinical development, working with clinical trials and central lab activities as a sponsor, CRO, or at the site level
Experience of setting up bioanalytical and/or PD assays and related trouble shooting
Experience in biobanking, including handling regulatory requirements, compliance, and operational processes


Our offerWe offer a competitive salary, comprehensive benefits package, and opportunities for growth and advancement. The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations. We are an equal opportunity employer and welcome applicants from all backgrounds.
We invite you to joinour fast-expanding global organization towards being one of the leading players in oligonucleotide therapeutics.
If you believe this job would be a good match for you, apply as soon as possible but no later than December 15th, 2024.Kindly note that we will assess candidates on a continuous basis.
You apply easily here using the Send Application button where youwill be able to upload CV and cover letter in the system.
Welcome! Visa mindre

Arbetsbeskrivning
Sourcing Project Associate at AstraZeneca, Gothenburg
Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.


Do you have an interest in clinical supply chain and working with external vendors and are you a person who would like to be part of a truly global team and play a key role in getting medicines to patient – then join us as Sourcing Project Associate!


Pharmaceutical Technology and Development (PT&D) apply science and technology that turns concepts into actual medicines which help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.


Clinical Manufacture & Supply (C&MS;) within PT&D provides an agile and flexible end-to-end Clinical Supply Chain that manufactures, outsources and delivers supplies and services to hundreds of thousands of patients across the globe.


This is an consulting assignment at AstraZeneca with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.


Why AstraZeneca?
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.


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.  

Ansvarsområden
CM&S are now looking for a Sourcing Project Associate to join our global Sourcing function. We are seeking those who embrace change, show great initiative, flexibility and a willingness to learn. As Sourcing Project Associate, you will build working relationships with external suppliers and work in teams of internal experts (e.g., Technical, Quality Assurance, Procurement) in the sourcing of services and goods required by CM&S from external suppliers in support of global projects for AstraZeneca.


The supply chain areas managed by Sourcing are related to: Drug Substance, Drug Product, Devices & Intelligent Pharma, Analytical Services, Pack Label & Distribution and Comparators. This role will have a specific focus on sourcing the services required for Clinical Trial Pack, Label & Distribution and/or sourcing commercially available product for use in AstraZeneca sponsored Clinical Trials.


We would like to receive applications from people with excellent business admin skills, preferably who have worked with external suppliers as well as internal stakeholders in a supporting function.

Kvalifikationer
Essential requirements:
Good secondary and higher level qualifications (degree not essential), including Maths, English and Science, Supply Chain or Business subject
Good communication and team working skills
High organisation skills and confidence to work independently
Logical thinking to be able to apply processes
The ability to apply a rational approach to problem solving; making judgments based on sound reasoning, approaching problems in a logical manner
Concerns for standards
High numeracy and literacy skills
Digital literacy
Ability to learn
Self-motivation / Initiative



Desirable requirements:
Experience of working with external suppliers
Technical knowledge for the activity being sourced (Clinical Supply Chain)



For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.



Ansökan
2022-09-15, welcome with your application at www.randstad.se.
For more information: Veronika Knudsen, [email protected]  

Om företaget
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity


We are currently looking for a project coordinator to work with a group of scientists responsible for the build of an industry-leading automated chemistry lab. You will be joining the Compound Synthesis & Management department at the AstraZeneca site in Gothenburg, Sweden.


This is a consultant assignment at AstraZeneca. 


Why AstraZeneca?
Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying, and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.



Responsibilities
As part of the team, you will take responsibility for a variety of administrative tasks related to the “Automated Chemistry project” like for example setting up new vendors in the AZ purchasing system, placing and tracking purchases, ensuring correct and seamless invoice payments, planning and organising travel, setting up and maintaining document archives, etc.


You will furthermore join in- and external project meetings and be responsible for taking and distributing meeting notes.

Qualifications
Essential requirements:
Minimum of 3 years of experience as project coordinator and/or administrative support
Excellent knowledge of Microsoft Office software (Excel, Word, Outlook, etc.)
Familiar and experienced with project management software (Jira, Slack, Trello or alike)
Keen on rapidly learning new IT applications
Very good English, both spoken and in writing
Great teamwork and communication skills, both verbal and written
Working independently, taking own initiatives, and having a positive, goal oriented and problem-solving attitude
Good multi-tasking, time management and organizational skills

 
Beneficial qualifications and skills:
Background in a natural science like for example chemistry or biology
Experience with software like Coupa (purchasing) and Concur (travel booking)



For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
So, what’s next? If this sounds like your next challenge - apply today! But at the latest 2022-08-18. Welcome with your application at www.randstad.se.



About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.


Pharmaceutical Technology and Development (PT&D) is the bridge which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.


Our global Clinical Program Supply Chain team is growing, and we are now looking for Clinical Supply Planner to join our team. Maybe you are one of them? This is a relatively new role in our organization, and you will have a fantastic opportunity to shape & develop the role to drive maximum value for the organization.


As a Clinical Supply Planner you will translate the programme level demand into a supply plan and execute the plan. This will be accomplished by developing and executing optimized plans inline with the Clinical Supply Chain Strategy. You will work closely with Clinical Supply Chain Programme Leads (CSPL) and Clinical Study Leads to match demand & supply and ultimately deliver lifechanging medicines to patients.Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.



Responsibilities

Accountabilities include:


 Translating demand in to supply plans, which meet the inventory strategy set out by the Programme Lead (CSPL)
Providing forecasts to our supply chain partners for each of the bill of material levels in the supply chain
Executing the supply plan to ensure kits are available to meet patient demandplacing orders with a range of supply chain partners
tracking progress & escalating issues
ensuring timely release of materials through co-ordination of supply chain team

Owning inventory; Creating and allocating material to match individual study demand & maintaining accurate stock keeping records




Qualifications
Required Skills & Knowledge


Degree in supply chain related or drug development discipline or equivalent qualification or experience.
In depth knowledge of R&D supply chain and drug development processes.
Knowledge of pharmaceutical production, supply chain principles, good manufacturing practice, Food and Drug Administration requirements (or equivalent) and Customs rules and regulations.
Proficient IT skills and an aptitude for systems.
Excellent analytical skills and an interest in using data to drive decisions
 Super user for our key supply planning tools



 Additional Requirements


Demonstrated technical skills and mindset in supply chain management including supply planning & inventory management
Experience of supply chain management tools
 Good understanding of the principles of risk.
Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
 Demonstrated experience of training and coaching colleagues
Excellent English written and verbal communication skills.



For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.



Application
2022-07-01, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström, Consultant Manager, [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Due to our promising pipeline and the growth of our Early Clinical Operations team, we have an open position for Global Study Leader (GSL). Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows AstraZeneca people to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology. This is a consulting assignment at AstraZeneca in Gothenburg.

As a GSL you're responsible for delivery of all aspects of global clinical studies. You will lead and maintain oversight for cross-functional teams comprised of internal and external partners. Ensuing delivery of clinical studies are done effectively and in accordance with clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & standard methodologies and AZ values & behaviours.

Responsibilities
You will lead, provide guidance and delegate appropriately to a cross-functional study team or lead all aspects of outsourced delivery activities. You will ensure studies are progressed as planned, driving achievement of milestones according to timelines, budget and quality standards. You may work on several studies at any one time. To do this successfully you will be able to lead and facilitate communication across multiple functions, work with multiple external service providers, ensuring delivery and performance to contracted goals and timelines/budget.

You will be accountable for leading the identification of overall study-level risk management activities and ensure mitigation strategies are implemented effectively. You'll be accountable for study budget management (and re-forecasting where required) through the study lifecycle and be able to drive and contribute to all aspects of study operations, including protocol writing, feasibility, vendor selection/start-up, site communication, database locks etc. You'll also work on non-drug project work such as process improvements as discussed and agreed upon with their line manager. May act as subject matter expert for a particular process or system within Early Study Management.

Qualifications
Essential requirements:
You will be experienced in global clinical project management, comfortable with leading and running cross-functional study teams and leading external providers
University degree (or equivalent educational/work experience), preferably in medical or biological sciences or field associated with clinical research
Extensive knowledge of clinical study management, ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
Extensive and proven experience in driving operational delivery to timelines, cost and quality and leading cross-functional study teams
Strong strategic and critical thinking abilities and ability to manage complex situations
Proven experience leading delivery through internal and external organisations


Desirable requirements:
Advanced degree, Masters level education (or higher)
Project management certification
Proven project management experience on a global level
Experience in all phases of a clinical study lifecycle

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-06-19, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Linnea Öster [email protected] or Birgitta Nyström [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, analytical methods and CMC project leadership needed to support early clinical trials, encompassing both small molecules and new modalities such as microRNA, messenger RNA and antisense oligonucleotides, across the whole range of AZ’s therapeutic areas.

The manufacturing units within Early Product Development and Manufacture (EPDM) in Gothenburg is accountable for manufacture of a vast portfolio of early investigational medicinal products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers, mainly for Phase I and II). We are supplying drug product to AZ clinical studies globally and are a vital part to enable early phase clinical trials, delivering a critical step on the path from idea to the patient. In short, we are the first in line to manufacture what could improve the lives of numerous patients around the globe. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
Within the EPDM manufacturing Units, 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. We expect the successful candidate to:
Assume responsibilities toward timely manufacture of numerous drug products in line with the plans agreed within EPDM.
Focus on practical hands-on work in our GMP facilities and lead a group of assigned persons through a manufacture campaign.
Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinicl manufactures.
Author Master Manufacturing Records together with other required documentation and setup transactions in Material Management Systems. Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
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.
Being entrepreneurial and driving initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for customer.


Qualifications
We are looking for a scientist with excellent collaboration, communication, and planning skills balanced with the ability to work independently and hands on with complex equipment. You will need a strong sense of responsibility, team work and delivery focus.

You have a MSc in Pharmacy or engineering or experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is required for this role. Excellent documentation skills, both in English and Swedish 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.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-06-17, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Linnea Öster [email protected] or Eleonor Ehrman +46733434109

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Do you have expertise in, and passion for, Supply Chain? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

We have an exciting opportunity for a Clinical Supply Program Lead/Associate Clinical Supply Chain Lead, depending on your background and experience. This could be an opportunity for development to join our team!

The Clinical Supply Program Lead is a key role accountable for the end to end clinical supply chain of a global programme of products. You will have a specific responsibility for the long-term strategy and will be a strong influencer in its design.

Pharmaceutical Technology and Development (PT&D) are the bridge which turns forward-thinking science into actual medicines that help millions of people. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Responsibilities
What you'll do
As a key partner working across different organisations, you will represent Clinical Supply & Operations in PT&D and Global project teams, as well as leading a matrix multi-functional team to drive strategy and to manage supply chain performance through key performance indicators. You will;
Be responsible for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio
Lead the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project
Work in conjunction with the Supply Chain Planner to balance short to mid-term Supply and Demand, Inventory Management and input into D&OP; Process
Establish development projects to ensure the delivery of the supply of materials, moving from development sources to commercial sources of manufacture
Understand GMP (Good Manufacturing Practice) and the impact it has on supply chain activities
Monitor the performance of the Supply Chain and optimize for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk
Be accountable for a significant budget for supply activities and materials for a project
Ensure timely delivery of information to meet internal and external regulatory and legal requirements
Manage change in demand and supply, resolve issues, advancing when appropriate


Qualifications
Essential for the role
Extensive experience of working in supply chains
Significant experience of business relationship management
Capability in partnering, influencing and optimising customer requirements
Knowledge of Clinical Supply Chains, drug development process and GMP standards
Awareness of GXP Standards within a Clinical environment
Demand Management and forecasting experience
Strong Project Management, change management and risk management capability


Desirable for the role
Proven technical skills and mindset in supply chain management including demand management, supply chain design, optimisation and delivery
Consistent track record of leading global cross functional teams
Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries
Solid understanding of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-06-02, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Linnea Öster [email protected] or Birgitta Nyström [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Pharmaceutical Technology and Development (PT&D) is the bridge which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.


Our global Clinical Program Supply Chain team is growing, and we are now looking for Clinical Supply Planner to join our team. Maybe you are one of them? This is a relatively new role in our organization, and you will have a fantastic opportunity to shape & develop the role to drive maximum value for the organization. This is a consulting position at AstraZeneca in Gothenburg.

Responsibilities
As a Clinical Supply Planner you will translate the programme level demand into a supply plan and execute the plan. This will be accomplished by developing and executing optimized plans inline with the Clinical Supply Chain Strategy. You will work closely with Clinical Supply Chain Programme Leads (CSPL) and Clinical Study Leads to match demand & supply and ultimately deliver lifechanging medicines to patients.


Accountabilities include:
Translating demand in to supply plans, which meet the inventory strategy set out by the Programme Lead (CSPL)
Providing forecasts to our supply chain partners for each of the bill of material levels in the supply chain
Executing the supply plan to ensure kits are available to meet patient demand
placing orders with a range of supply chain partners
tracking progress & escalating issues
ensuring timely release of materials through co-ordination of supply chain team
Owning inventory; Creating and allocating material to match individual study demand & maintaining accurate stock keeping records


Qualifications
Required Skills & Knowledge
Degree in supply chain related or drug development discipline or equivalent qualification or experience.
In depth knowledge of R&D supply chain and drug development processes.
Knowledge of pharmaceutical production, supply chain principles, good manufacturing practice, Food and Drug Administration requirements (or equivalent) and Customs rules and regulations.
Proficient IT skills and an aptitude for systems.
Excellent analytical skills and an interest in using data to drive decisions
Super user for our key supply planning tools

Additional Requirements
Demonstrated technical skills and mindset in supply chain management including supply planning & inventory management
Experience of supply chain management tools
Good understanding of the principles of risk.
Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
Demonstrated experience of training and coaching colleagues
Excellent English written and verbal communication skills.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-05-27, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström [email protected] or Eleonor Ehrman +46733434109

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The Arena:
Global Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:
The ever-increasing complexity of regulations and product portfolios
Growing demand for data due to increased public and regulatory scrutiny
Global collaboration and standardization of formats and processes across the markets
Increased use of partners and outsourcing


Responsibilities
The role:
The Manager, Regulatory Information is primarily responsible for supporting the management, collection, coding and analysis of AstraZeneca regulatory information, the Global Product Registration List and regulatory data standards such as XEVMPD and IDMP. This is a consultant assignment at AstraZeneca in Gothenburg.

Typical Accountabilities:
Manages the collection, coding and analyses of regulatory information for assigned products in accordance with regulatory data standards, quality control and quality improvement methodologies.
Compiles and delivers XEVMPD or other regulatory information-based submissions to health authorities.
Develops self in topic areas critical to successful delivery of the RI remit. Particularly, technical skills (XEVMPD, IDMP), knowledge of international regulations and skills (communication, project management).
Engages with partners, affiliates, subsidiaries or other stakeholders to collect regulatory information and to ensure compliance with procedures and standards.
Monitors the environment for changes in legislation related to regulatory information.
Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
Identifies opportunities for continuous improvement.
Prepares business reports or alerts in response to business or health authority request.
Ensures collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes and regulatory data standards.


Qualifications
Minimum requirements
University degree in the life sciences or IT
Experience in pharmaceutical/medical industry
Knowledge of pharmaceutical drug development process
Strong analytical and critical thinking ability
Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
Able to manage productivity responsibilities


Preferred experience and key factors
Good problem and conflict resolution skills
Ability to set and manage priorities, performance targets and project initiatives
Ability to innovate best practices with business process analysis and design
Ability to thrive in a rapid paced environment

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-01-13, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström, [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Are you experienced in Pharmacovigilance or Drug safety? We are now looking for a Pharmacovigilance expert / Drug Safety expert for an exciting consultant assignment at AstraZeneca with start in September.

Short role description
Support and drive discrete improvement projects relevant to the scope of the QPPV function.
To provide support for maintenance of Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS) and PRAC monitoring activities.
Provide project management support for dedicated project(s).


Responsibilities
Support and drive PV Excellence by inputting to ad hoc allocated tasks in relation to:
Developing and maintaining framework(s) for content quality measurement and oversight.
Assessing the effectiveness of initiatives with identification of subsequent further improvement actions as needed.
Developing standardised best practice templates, authoring instructions and guidance for production of Patient Safety outputs.
Promoting and ensuring Patient Safety outputs are produced in accordance with High Performance Authoring (HPA) principles.
Implementation of standards and skills with Patient Safety Therapeutic Area teams and individuals in close collaboration with Process Area Leads (PAL) and Process Owners (PO).
Ensuring the adoption of standards and skills by developing and providing process competence and capability build training to functional groups within Patient Safety.
Providing specialist knowledge and support to be recognized as experts and source of reference for safety teams and other stakeholders.
Contribution to the definition and assessment of measurable objectives and delivery targets.



Provide support for:
Maintenance of Pharmacovigilance System Master File (PSMF)
Summary of Pharmacovigilance System (SPS)
Monitor PRAC outputs per SOP


Provide project management support for dedicated projects

Upon request participate and/or support activities for GVP audits/inspections

Qualifications
Essential
Health professional degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
Extensive operational experience in production of core safety outputs
Good knowledge and comprehension of relevant pharmacovigilance legislation
Excellent medical writing skills
Excellent communication skills
Experience and ability to develop and implement new standards and best practices
Strong project management skills
Proven ability to lead teams and collaborate in a continuous improvement
Good strategic thinking capability


Desirable
Regulatory strategy knowledge and experience
Clinical development knowledge and experience
Lean Sigma experience

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2020-08-26, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Birgitta Nyström [email protected] or Eleonor Ehrman +46733434109. 



About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

We are now seeking for a Manager within Regulatory Information to AstraZeneca, Gothenburg. This is a temporary assignment lasting until 31st of July 2020.

Job Description Summary

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The Arena:

Global Regulatory Operations (GRO) manages several part?s of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:

• The ever-increasing complexity of regulations and product portfolios
• Growing demand for data due to increased public and regulatory scrutiny
• Global collaboration and standardization of formats and processes across the markets
• Increased use of partners and outsourcing

The role:

The Manager, Regulatory Information is primarily responsible for supporting the management, collection, coding and analysis of the Global Product Registration List; regulatory data standards (XEVMPD, IDMP); and regulatory information.

This is a temporary assignment lasting until 31st of July 2020.

Typical Accountabilities:

• Manages the collection, coding and analyses of regulatory information for assigned products in accordance with regulatory data standards, quality control and quality improvement methodologies.
• Compiles and delivers XEVMPD or other regulatory information-based submissions to health authorities.
• Develops self in topic areas critical to successful delivery of the RI remit. Particularly, technical skills (XEVMPD, IDMP), knowledge of international regulations and skills (communication, project management).
• Engages with partners, affiliates, subsidiaries or other stakeholders to collect regulatory information and to ensure compliance with procedures and standards.
• Monitors the environment for changes in legislation related to regulatory information.
• Reviews and evaluates regulations, guidelines and technical specifications related to regulatory information processes and regulatory information data standards.
• Identifies opportunities for continuous improvement.
• Prepares business reports or alerts in response to business or health authority request.
• Ensures collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes and regulatory data standards.

Minimum requirements

• University degree in the life sciences or IT
• Experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process
• Strong analytical and critical thinking ability
• Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
• Able to manage productivity responsibilities

Preferred experience and key factors:

• Good problem and conflict resolution skills
• Ability to set and manage priorities, performance targets and project initiatives
• Ability to innovate best practices with business process analysis and design
• Ability to thrive in a rapid paced environment

 

Please submit your application by attaching your CV and personal letter in English (interviews are held continuously).

If you have any questions about the assignment, do not hesitate and contact Markus Dahl ([email protected]).

Modis is a staffing & recruiting company and is part of the Adecco Group, the world´s leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates. Visa mindre