​QC Chemist

Clinical Research Associate II/II or Senior CRA - Permanent - Oncology Business Unit To be based in either our Prague office or home-based Candidate Must Haves - N.B. Candidates will NOT be accepted under agency ownership if they do not fulfil the below criteria - A Scientific related degree - Significant independent monitoring experience - Significant Oncology experience - We will not accept Lead CRAs or Project Managers for this role candidates have to be happy to monitor for the next 2 years at least.

Pfizer Senior Regulatory Manager BioTX Belgium Brussels Global Chemistry Manufacturing Complaince (GCMC) is committed to support Biotherapeutic Pharmaceutical Science (BioTX PharmSci) and Global Supply (PGS) as competitive advantage for Pfizer by consistently delivering high quality regulatory strategies and timely submissions across product lifecycle. GCMC is fully engaged in drug development product extensions and maintenance. GCMC representatives participate on teams and at sites as GCMC experts and overall advocate for effective drug development and maintenance paradigms The Senior Regulatory Manager BioTX will be responsible for execution of Regulatory Strategies at the Puurs Manufacturing Site for Drug products including the regulatory assessment of change controls and deviations. Role Description The Senior Regulatory Manager is participating to elaboration of Global CMC strategies and is responsible for their execution submission preparation and compliance activities for post approval BioTX projects. Potential project responsibilities may include monoclonal antibodies other recombinant proteins vaccines peptides and nucleotides. Acts as GCMC liaison between manufacturing sites and GCMC sub-teams. She/He leads the preparation of CMC information for submission to global regulatory agencies generates CMC strategies assesses risks and develops contingency plans for Puurs projects including major complex applications. The Senior Regulatory Manager act as the GCMC strategist and supports to the Global CMC Product Lead within cross-functional project teams involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions. The person is accountable for assigned CMC programs managing day-to-day delivery of plans and strategic activities for specific projects including post-approval activities and compliance of commercial products. She/He operates independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. The Senior Regulatory Manager creates / contributes to the development of internal policies processes and procedures supporting the progression and maintenance of the Pfizer BioTX portfolio at large. This position will be based in Brussels with frequent travel to our Manufacturing site in Puurs. This role collaborates across GCMC and functional activities in a matrix environment with globally located cross-functional project teams including representatives from World Wide Pharmaceutical Sciences / Worldwide R&D / Global Supply/Worldwide Regulatory Affairs. She/he may participate in pharmaceutical industry initiatives and support the development of Pfizer positions to external regulatory policies. Responsibilities She/He serves as a GCMC strategist for projects within Post Approval BioTX portfolio taking place at Puurs providing regulatory assessments and expertise and developing regulatory strategies jointly with Product Lead and Regional Strategists. The Senior Regulatory Manager BioTX acts as the GCMC representative and contributes support to the Global GCMC representative within cross-functional project teams. Accountable for Puurs projects and activities independently completing work within assigned work group/project teams for multiple projects. The person interprets CMC regulatory requirements assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. She/He will be responsible for the development of CMC documentation coordination of global submissions including the assessment and management of commercial license status maintenance of product compliance through deviation and change control assessments. The person will have ability to collaborate effectively across a network of other stakeholders partners and customers to deliver high quality CMC documentation and ensuring the compliance of the Pfizer BioTX portfolio. Manages issue resolution of CMC information with project/program stakeholders. The Senior Regulatory Manager BioTX is able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives. Qualifications EDUCATION & EXPERIENCE Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc) An experienced regulatory CMC professional or an individual with regulatory/compliance expertise in biopharmaceutical manufacturing (ideally with parenteral drugs) and/or specific regulatory domain (5-7 years of prior international regulatory experience with 3-5 years in CMC). Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned proj

Senior Research Physician Rheumatology The Company AstraZeneca 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 AstraZeneca 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. Our development project teams work globally and opportunities exist at the following R&D sites: About 2 300 people work at our state of the art R&D facility in Mölndal where efforts within the respiratory and inflammatory therapeutic area (R&I) are focused on development of new medicines for treatment of diseases such as asthma COPD and rheumatoid arthritis. Also at the same site in Mölndal another therapeutic area (CV/GI) is developing medicines for cardiovascular and gastrointestinal diseases. Alderley Park situated in the heart of Cheshire in the North-West of England is AstraZeneca's largest Research and Development site worldwide employing almost 4 000 people including chemists bioscientists clinical researchers and regulatory specialists. Alderley Park is central to late phase development projects in phase II and is an important centre for global business functions such as Operations International Sales & Marketing Product Strategy & Licensing and Information Services. It also houses the global Advanced Lead Discovery Centre and recently opened a new Pharmaceutical Development laboratory building. Wilmington………………(addlight0 ) We work in close collaboration with the biologics division of AstraZeneca (MedImmune) based in the US. Global Medicines Development In the Global Medicines Development function you will be given the opportunity to work in a truly international working environment with opportunities to meet and discuss with key opinion leaders other medical colleagues and experts in basic science as well as commercial and regulatory functions. Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization. The successful candidate will work in a wide range of aspects in pharmaceutical medicine and due to the global responsibilities there will be a multitude of contacts with health authorities colleagues and marketing companies within AstraZeneca. This is an opportunity to take on the challenges of clinical development in a group of positive focused and highly motivated colleagues. The Respiratory and Inflammation portfolio includes exciting late stage development activities in rheumatoid arthritis and has recently been enhanced through the acquisition of Ardea and a major collaboration with Amgen. The MedImmune portfolio also includes programmes in arthritis scleroderma and SLE. The Senior Research Physician Role In this position you will be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of rheumatological disease. As a Senior Research Physician you will have an important role providing medical and scientific leadership in the innovative design execution and interpretation of clinical trials in one or more development programmes. You will be involved in building strong relationships with a network of external scientific experts and opinion leaders. You will work closely with colleagues in other functions including Patient Safety Regulatory Affairs and Clinical Operations. You will have the opportunity to be involved in all phases of the drug development programme and may also be involved in supporting discovery teams in the identification and validation of novel biological targets and establishment of biomarkers. You will provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities. You will provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature. You will participate in the preparation of publications and presentations at scientific meetings and congresses. Requirements (B) You are a fully qualified physician with specialist clinical qualifications in rheumatology You have a strong clinical research record in a relevant disease area You have significant experience of conducting clinical research trials in a relevant disease area You have good teamwork and collaboration skills You have good verbal and written communication skills in English You are able to travel nationally and internationally More information For more information about the position please contact any of the following: Kevin Cheeseman Clinical Director Respiratory & Inf

ROLE DESCRIPTION ASSET LEADER ROLE: Asset Leader REPORT TO: Functional Line Manager LOCATION: Cambridge UK THE ROLE The Asset Leader (AL) is accountable for ensuring the Organisation gains the greatest potential for an asset. The AL will be supported by the Asset Team. The AL is empowered to make decisions and accelerate the delivery of each asset in line with the assets potential value and look for all meaningful ways of increasing the value of that asset throughout its lifecycle. This role is of key strategic significance within the organisation. The Asset Leader is the single point of accountability across the asset team. The AL is accountable to the POT (Portfolio Optimisation Team) for all key asset decisions and overall budget. AREAS OF FOCUS All asset deliverables as detailed in the Integrated Asset Plan (IAP) including asset hypothesis TPP development & commercialisation activities on budget and per timelines All asset communication internally & with external partners and Executive Leaders Responsible for the formation of Core and Extended Asset Teams in liaison with relevant line managers Establish and adapt the asset IAP and drive the development and commercial activities related to the asset seeking POT approval of any deviations to the plan All strategic asset decisions ensuring that they adhere to any patient safety patient ethics legal and or regulatory requirements Lead the asset team to implement the IAP Be the primary point of contact for the POT the SOT & the Board for the asset keeping each informed as appropriate with regular progress reporting Champions the asset to the wider organisation serves as interface to other functions as required Aligns with franchise lead team to ensure alignment of asset strategy to core franchise strategy KEY ACCOUNTABILITIES „h Ensuring that the Asset achieves maximum potential for the business „h Prepare and obtain approval for TPP asset hypothesis and IAP through the POT „h Keep the SOT informed and engaged on the TPP asset hypothesis & IAP status „h Ensures delivery against the IAP „h Building effective relationships with asset team members to develop and implement the various functional activities including regulatory Market access Clinical development Early science & research nonclinical drug safety pharmacovigilance commercial medical affairs and Alliance management „h Successfully lead the core functional asset team manage the asset team performance „h Accountable for Asset budget and resourcing in collaboration with Finance teams. „h Collaborate with functional heads for annual objective setting and performance appraisal review for asset team members „h Liaison with independent associated companies (IACs) and provide with updates. Respond to requests from IACs. P a g e 2 | 3 KEY SKILLS „h Demonstrable leadership skills in line with Asset Leader behaviours. „h Selfstarting mindset together with a proactive and highly motivational personal style. „h Ability to prioritise and effectively handle multiple assignments/projects concurrently. „h Strong influencing aptitude and thus able to motivate others to action even without direct accountability. „h Evident social competence and cultural sensitivity with the ability to manage cross functional teams. „h Excellent written and verbal communication skills in English with strong presentation competencies that enable effective communication at all levels. „h Ability to present to Executive Leaders. „h Very strong intellectual capabilities underpinned by keen analytical acuity. Proven track record in leading crossfunctional teams and comfortable working effectively in a complex yet highly collaborative environment. „h Creative and innovative in approach „h Strong focus on delivery and implementation. „h Ability to work with minimal input and direction „h Builds solid relationships based on integrity consistency accessibility with a commitment to leading organisation „h Clearly communicate team responsibilities and empowers others to implement „h Driven to achieve optimal results for the asset „h Ability to communicate and work with executive leaders core asset team and extended asset team as well as across functional areas. „h Ability to handle conflict situations and critical negotiations „h Politically savvy „h Ability to analyse financial metrics and data. Financially astute QUALIFICATIONS & EXPERIENCE „h Degree qualified ideally within a relevant field life sciences or commercial preferred. „h Either a background in R&D or life sciences and/or proven commercial experience within pharmaceutical industry) „h Ability to interpret scientific data „h Track record of successfully leading a cross functional team „h Experience within an international environment and ability to work collaboratively to produce optimal results. „h Ability to manage complexity „h Experience working within the pharmaceutical industry ideally with a background in drug development or commercialisation

1. Competences Lead audits of assigned entities to assess compliance with regulatory and Celgene requirements; identify compliance risks and drive concurrence regarding their severity. Support establishing and maintaining processes and SOPs for GMP/GDP audit function within the International region. 2. Skills/Knowledge Required Strong / deep knowledge of core auditing processes Broad knowledge of all relevant laws / regulations and deeper knowledge or relevant laws / regulations in multiple GMP/GDP area(s); ability to translate regulations into operational requirements Broad knowledge of all relevant Company policies / procedures / standards with deeper knowledge of Company policies / procedures / standards in multiple GMP/GDP area(s) Strong / deep knowledge of assigned Celgene business units processes management systems products services and technologies Organization and planning abilities with attention to detail Problem identification and analysis skills Basic understanding of risk management and ability to evaluate an organizations risk exposure Proficient in Microsoft Office and other standard applications Good understanding of business functions and internal controls to assess compliance in auditee organizations where clear standards and procedures do not exist Training and coaching skills Willingness and ability to identify and investigate areas of potential risk; healthy skepticism Commitment to self-development and ability to stay abreast of internal and external requirements Independent thinking 3. Duties and Responsibilities Audit Planning and Schedule Development Provide input to the risk assessment of assigned auditable entities to identify the risk based audit frequency for each entity Identify new risks that may not be accounted for in the risk assessment template and communicate to Sr. GMP/GDP Auditor and/or Exec. Director QA Operations International Audit Preparation Define the scope and depth of the draft audit agenda Review auditees audit history and other supporting information; provide to audit team members for use in preparation activities Meet with the business audit team and SMEs to refine the risk assessment ensure all risks are identified and finalize the audit agenda Issue audit agenda; request required pre-audit information from the auditee Ensure that the audit owner and potential observation owners are identified; lead resolution of issues regarding identification of owners Resolve schedule issues Lead pre-audit team meeting; review pre-audit information with the audit team Audit Conduct Conduct opening meeting with the auditee auditee SMEs and Celgene audit team including Celgene SMEs to review the agenda and confirm agreement on scope and timelines Lead the execution and conduct of the audit Ensure the audit team uses relevant audit guidelines and that the team executes the defined audit agenda Lead all Celgene audit team/SME meetings and joint auditee/Celgene audit team meetings that occur during and at end of the audit; verify audit observations with auditees Ensure that findings and observations are identified evidence is collected where possible all potential critical observations are immediately identified and auditee expectations and next steps are identified Escalate potentially critical observations to the Exec. Director QA Operations International. Organize meetings with Exec. Director QA Operations other QA functions Legal Reg. Affairs and others to discuss critical or major findings and potential impacts Audit Reporting Lead the grading of observations and the identification of observation and effectiveness check requirements ensuring that differences in opinion are resolved Collate and edit the draft audit report Provide draft audit report to the Sr. GMP/GDP Auditor the Celgene audit team and as needed to the Exec. Director QA Operations International for feedback; finalize the report and ensure it is distributed as per Celgene practices Audit Follow-Up Review and track all observation responses and observation actions that result from an audit Determine if observation responses are complete and if not negotiate with observation owner(s) Review evidence to determine if it is acceptable and negotiate revised dates with the observation or action owner(s) if needed. Escalate all overdue and unacceptable responses. Determine when an observation can be closed; issue Observation Responses Complete and Audit Complete certificates Review timeline extension requests to determine if justification and new due date are acceptable; reject unacceptable requests. Communicate decision and rationale to observation or action owner. Ensure that the subject of the extension request is updated with new date. Health Authority Inspections Provide front-room/back-room support during HA Inspections as necessary Compliance Standards and Training Support establishing and audit procedures (SOPs Standards) for the International region under the direction

he Director Project Management (DPM) will provide functional leadership to PM/SPM support and oversight of large multi-national projects may be responsible for directing and leading the activities of a therapeutic area within a Region; may be responsible for directing large national or global projects or a program of projects and/or complex projects in terms of customer/deliverables. Works effectively across multiple divisions to direct the delivery of projects/programs within cost time and quality requirements Provide direct supervision support training and mentoring to project managers Immediate supervision of employees prepares and conducts performance appraisals and salary reviews and applies company policies Works with leadership in all functional areas on the continuous development/improvement of business processes to support cross functional teams and to ensure that work is uniform complete and managed appropriately instigating and leading change initiatives Communicates with sponsor (s) to obtain direction and feedback on scope of work and performance Serves as a liaison with Business Development and Bids/Contracts for the client presentations and proposal development Assists in resource utilization policy development and implementation of goals RESPONSIBILITIES: Tasks may include but are not limited to: Direct line management of project management reports Accountable for multiple projects simultaneously Lead core project team and facilitate their ability to lead extended/complete project team Lead cross unit coordination both internal and external inclusive of sub-contractors Define and manage project resource needs and establish contingency plans for key resources Ensure successful design implementation tracking and revision of project plans for assigned projects Promote effective teamwork among project team members Resolve conflicts as needed Ensure appropriate communication on project-related matters with Senior Management Meet financial performance targets for the assigned clinical projects/programmes Ensure project deliverables are met according to both WCT and client expectations Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects May be key client contact for assigned projects/clients Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research Perform other duties as assigned by management Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Required Skills OTHER SKILLS AND ABILITIES: Strong leadership skills Strong financial acumen Excellent judgment and decision making skills Effective oral and written communication skills including the ability to communicate in English both orally and in writing Excellent interpersonal skills and problem solving ability Effective organizational skills and negotiation skills Expert knowledge of project management principles and application Knowledge of budgeting forecasting and resource management A relationship builder who is able to work effectively in matrix organizations A clear and deep understanding of the challenges of working in a multicultural service organization Knowledge of regulatory guidelines and Directives Skilled in process improvement especially as it applies to clinical trials clinical development and project management Knowledge of medical therapeutic area and medical terminology Strong marketing and negotiation skills Computer skills Required Experience REQUIREMENTS: University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge skills and abilities Minimum of ten (10) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks o In lieu of the above requirements candidates with > five (5) years supervisory experience in a health care setting and eight (8) years clinical research experience in the pharmaceutical or CRO industries will be considered A demonstrated track record of success in clinical development and in leading and developing professional staff in a project led environment Proven experience developing and managing the budgets and resources of a segment of the business Experience using project management software Experience in conducting global clinical trials Available for domestic and international travel including overnight stays Valid Passport Ability to drive and have