Office Associate Salary in Boston, MA

This is what you will do:DI&A Capability Lead for US Commercial reports to the Head of IT Data, Insights & Analytics and is a critical role in Alexion IT RDU organization. The focus of this role is to take patient-centric data-driven approach to deliver large Data & AI Programs across Commercial, Patient Services, and Market Access functions.Alexion is looking for a sharp-minded, assertive, and energetic DI&A leader who will be responsible for establishing the strategy, functional plans, and delivery of products/ projects/programs to meet the short- and long-term goals and metrics of the organization. Should be able to conceptually architect and design data and analytics solutions to meet specific business demands, driving value from information and ensuring end-to-end delivery.We are looking for adaptable candidates with a broad set of technology skills to be able to lead robust data solutions that leverage disparate datasets, data lake repositories, engineering workflows, visualization, and Data Science toolkit. The candidate will have to oversee global demands and work with internal and vendor delivery organizations to ensure the right delivery approach/model has been followed.The candidate needs to be client-oriented, capable of independently developing sophisticated data foundation, business analytics, data engineering & integration solutions, and skilled at presenting solutions to broad audiences within IT and business groups.The right candidate for this position should have a proven track record in Commercial, Patient Services, and Market Access functions for an international Pharma/Biopharma company. They should have superior program delivery and team management capabilities, strong technical skills, and the ability to manage vendor relationships. Alexion RDU is looking to build the next generation of patient-centric digital health products and we are looking for a qualified individual whose passion is understanding how to best utilize healthcare data and platforms to drive business innovation.You will be responsible for:DI&A Capability Lead for US Commercial will be responsible for supporting IT and business-driven activities which will include the following:Understand business, conceptualize analysis framework, define DI&A requirements, and coordinate implementation with business partners, IT Digital teams and external partners for delivering enhanced digital experience to patients and customersResponsible to drive initiatives in Data Management, deploy DI&A enablement practices for master, reference and metadata and execute key strategies in building taxonomy/ ontologies and FAIR data products using multi-modal datasetsResponsible to deliver data engineering services, ingesting data in the Alexion Data Platform, creating data hubs to integrate and distribute data in the form of products, and supporting integration to digital applications to generate insights through AI/MLDrive operationalization and adoption of data products and AI/ML solutions in generating insights supporting patient and HCP engagementProvide consultancy advice, as a trusted partner, to both the global and regional stakeholders within the business and other technology teams from strategic partners / vendors for on-going and new implementation projects and ensure they are aligned with organization goalsYou will need to have:Strong technical delivery management experience in Data Engineering, Data Foundation and Observability and AI/ML across functions and geographiesIn-depth working knowledge of data domain modeling and expertise in designing taxonomy and ontology, that facilitate the management of key master/reference data products like Engagement, Patient, Healthcare Professional / Organization, Vendor, Payer, Product, and their associated hierarchiesOrganize data at the macro level using conceptual/logical data models as a standard for the trusted source and for consuming applications to inherit, with the ability to extend the data model to bridge internal data with 3rd Party data sources like Specialty Pharmacy, Claims, and Lab dataAbility to successfully lead a team of Business Analysts, Data Engineers and Analytics and AI Developers through all phases of the development life cycles, including concept definition, product design, development, implementation, and testingAt least 6 years of experience in leading, designing, and developing data lake and data integration architectures, using FAIR data set and prior experience in managing end-to-end engagements in BI using Qlik Sense and Data Science languages like R and Python; should possess knowledge of Cloud platforms like AWS suite, modern data storage layer like Snowflake, dbt, FiveTran and cloud data management applications like Immuta, Collibra and Reltio/ Veeva NetworkKnowledge of Privacy and healthcare interoperability standards like GDPR, HIPAA and HL7, FHIRFamiliarity with Git, Data-Ops, and Continuous Integration /Continuous Deployment pipelines and experience in Agile project executionBachelor's degree in a technical field of study (Computer Science/Engineering preferred) and have excellent communication, analytical and logical thinking skills, detail-oriented with an ability to take a macro viewWe would prefer for you to have:A Master's degree, MBA, or equivalent level of experience8+ years of digital and data transformation experience within biopharma industry with at least 3 years of managing complex transformationsPrior experience working on digital health initiativesIn-person statement for 3 days in the office:Expectation of working in the office 3 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Date Posted05-Feb-2024Closing Date28-Apr-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Join our Product Development team at Helen of Troy and make an immediate impact on our trusted brands: OXO, Hydro Flask, Osprey, Honeywell , PUR , Braun , Vicks , Hot Tools , Drybar , Curlsmith , and Revlon . Together, we build innovative and useful products that elevate people's lives everywhere every day.Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent!Position: Associate Director, Product Development, LiquidsDepartment: Product Development, Drybar and Hot ToolsWork Location: Boston, MA, Hybrid (work 3 days onsite)Hybrid Schedule: Helen of Troy associates enjoy the advantages and flexibility of a hybrid working model, allowing for in office 3 days minimum, and remote 2 days. Any changes to this working model would be communicated accordingly.What you will be doing:We are looking for a savvy, hardworking Associate Director of Product Development who is passionate about launching new products in the beauty sector. This position is essential in supervising the launch process from concept to launch, owning the day-to-day development activities for all new products from the innovation calendar that meet the overall strategy for the Helen of Troy liquids brands Drybar and Hot Tools.Manage all phases of the product development process and its tasks from identifying concepts up front to implementing them, supervising towards on time launches across Drybar and Hot Tools liquids.Has an in-depth background within the beauty industry, is up to date on the latest industry trends, ingredients, packaging, consumer, and competitor activity. Will be responsible for kicking off the conceptualization phase of the product development process, collaborating with marketing on concepts and completing the briefs.Strong product and brand focus, keeping the customer top of mind, ensuring the uniqueness of the product experience delivers upon the brand strategy.Drives and leads all aspects of the creation of the formulas and the day-to-day product development process multi-functionally, responsible for creating COGS sheets, sourcing high quality and efficacious on-trend and clean actives, works with contract manufacturers, selects quality prototypes for unique textures, performance and aesthetics, evaluates submissions based on target costs and claims and compares against the prototypes performance benefits, ensures successful pilot and production meeting all requirements for consistency throughout scaleup and signs-off.Advises the daily functions of packaging development from concept working with marketing, to executing on the packaging brief and sizing based off competitive analysis, championing corporate efforts to support social and environmental responsibility, evaluating packaging submissions that meet the brand profile, pricing target, moq's, timing and delivery of functionality.Works with Regulatory to ensure compliance, incis and labeling requirements are met.Align with R&D on detailed development for reformulations, fixing to resolve formulation challenges and stability and safety tests.Collaborate with Quality to establish parameters and maintain meticulous quality control to consistently produce high quality products.Works with supply chain and project management as a strategic partner in delivering the product on time through production and into the warehouse.Skills needed to be successful in this role:Demonstrated ability to prioritize and to identify when assistance is needed and seek help from appropriate parties.Excellent written and verbal communication skills, with an ability to problem solve.Strong attention to detail and ability to switch between projects without sacrificing quality and accuracy.Excellent organizational and time management skillsProactive and self-motivated individual with a passion for product development in beauty, staying up to date with industry trends.Minimum Qualifications:Bachelor's degree encouraged (relevant in-role experience and on-the-job education can qualify)8+ years in the personal care industry within product developmentExperience working with contract manufacturers and packaging suppliers.Authorized to work in the United States on a full-time basisBenefits: Salary + Bonus, Healthcare, Dental, Vision, Paid Holidays, Paid Parental Leave, 401(k) with company match, Basic Life Insurance, Short Term Disability (STD), Long Term Disability (LTD), Paid Time Off (PTO), Paid Charitable (volunteer) Leave, and Educational Assistance.Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.#LI-EB1#LI-HYBRID For more information about Helen of Troy, visit www.helenoftroy.com . You can also find us on LinkedIn , Glassdoor , Facebook , Instagram and Twitter . Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thinking, culture and background. We do not discriminate on the basis of race, color, religion, sex, national origin, sexual orientation, gender identity, age, marital status, disability, protected veteran status or any protected basis. We will provide individuals with disabilities reasonable accommodation to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at (915) 225-8000. Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO®, Hydro Flask®, Osprey®, Honeywell®, PUR®, Braun®, Vicks®, Hot Tools®, and Drybar® - many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.

Associate Director, Scientific Communications This is what you will do: The Associate Director (AD) of Scientific Communications, Neurology is responsible for facilitating the successful development and execution of publications strategies and plans for their assigned therapeutic area in alignment with Alexion brand and corporate strategies. The AD will collaborate with the Directors of Scientific Communication and may also function as independent lead for specific therapeutic area programs as assigned by the program head. The successful AD will engage with internal stakeholders including but not limited to Research, Clinical Development, Commercial, Biostatistics and Medical Affairs, as well as external authors, investigators, and publishers to ensure timely execution of the publication plan through high quality writing, reviewing, editing, revising, and placing impactful scientific and clinical abstracts, posters, oral presentations and manuscripts. In this role the Associate director will participate in the analysis and interpretation of scientific and clinical data, as well as in the identification of appropriate publication and presentation forums for the data. The Associate Director will also assist in the development of medical education plans, congress plans, literature summaries and maintain the repository of collateral publication materials including slide decks. The Associate Director will conduct literature searches as well interpret scientific literature, and provide assessments of competitor papers, posters, and other materials. The Associate Director will also participate in the supervision of consultants and medical communication agencies.You will be responsible for:Participate in the development and implementation of strategic publication plans for the assigned products and disease indicationsEnsure timely execution of the publications to produce high quality, accurate and impactful deliverables including abstracts, posters, oral presentations, manuscripts, and slide decksParticipate in the planning, development and implementation of the medical educational plan, and other scientific programs that communicate important information to the medical and scientific community. Also, to include collaboration and involvement in scientific symposia.Manage and track the publication plan to ensure its timely executionWork with external authors, investigators and thought leaders on abstracts, posters, oral presentations, manuscripts, review articles and slide decksParticipate in the analysis and, interpretation of scientific and clinical data, as well as the in the identification of appropriate publication and presentation forums for the dataConduct routine literature searches and interpret scientific literature for internal stakeholders, including competitor assessmentsEnsure compliance with Alexion's Publication PolicyYou will need to have:Advanced degree: PhD, PharmD, or MD5-7 years of relevant experience in a pharmaceutical company or Medical Communications agencyExperience in strategic publication planning (including scientific platforms), tactical publication planning and implementation, and the planning and development of medical educational materialsAbility to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programsMust be skilled writer with demonstrated ability to write / review / edit / place scientific articles, abstracts, postersStrong working knowledge of current good publication practices and guidelinesUnderstanding of the clinical development process, especially clinical study and global health outcomes data. Ability to collaborate with medical publications agencies, to plan, write and develop abstracts, posters, oral presentations, manuscripts, slide decks and content for scientific and educational programsExperience in working closely with thought leaders and authorsDemonstrated ability to work independentlyAbility to travel (US and International) as necessaryThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Background or prior experience in rare diseasesExperience in the planning and implementation of symposia and in the development of medical education materialsExperience with publication management software (e.g., Datavision)CMPP /AMWA certification highly desiredAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Associate Director, US Medical Review Committee OperationsThis is what you will do: The position of Associate Director, US Medical Review Committee (MRC) Operations is responsible for the overall implementation of strategic and complex projects within the US Medical Review organization and cross functionally. The Associate Director is responsible for all oversight and day-to-day operations associated with medical, legal, and regulatory review of non-promotional materials. Collaborate with therapeutic area US Medical Affairs teams, Regulatory, Legal, Compliance, and Medical Communications to ensure best practices, long-term planning, quality, and compliance with policies and standard operating procedures (SOPs). This includes coordinating and collaborating with the Medical, Legal and Regulatory leadership on execution of core projects, system enhancements, and operations related to vendor oversight and management. Guide and coordinate external agencies and vendor activities to ensure effective and efficient adherence to established SOPs. Develop and manage all applicable SOPs, working practices/instructions, training materials and ensure that all applicable MRC team members are trained accordingly.You will be responsible for: Providing oversight of US Medical Review Committee (MRC) process including maintaining system, training, management of coordinator, Standard Operating Procedures (SOPs) Assisting with project planning, development, and maintenance of departmental Policies, Standard Operating Procedures (SOPs); Work Practice Documents (WPDs); and related training materials (e.g., training matrices, training modules, learning management system training assignments) for all departmental, contracted and vendor employees.Developing and delivering durable and live trainings, including interactive training modulesInteracting effectively and collaboratively with therapeutic area Medical Affairs teams, Medical Communications, Compliance, Legal, Regulatory, and other MRC stakeholdersWorking collaboratively with US Promotional Review Committee (PRC) Operations team to support tactical planning process to consolidate database and process enhancements and to coordinate training requirements.Assisting in executing tactical deliverables identified during US Medical Communications objective setting and based on departmental strategic imperatives.Assisting with budget planning, forecasting, accrualsOverseeing the development and execution of departmental dashboards, metric reports, tracking, departmental communications to cross-functional partners (e.g., Global Medical Affairs; MRC team members), and departmental project plans.You will need to have:Bachelor's Degree2+ years of commercial or medical affairs operational experience; or project management experience within the biotech/pharmaceutical/device industryExcellent verbal and written communication skills as well as strong interpersonal and tactful negotiation skillsProject management skills with proven ability to prioritize, conduct, and meet project deadlines.Operational management experience with ability to determine essential components of requirements in order to include them in applicable policies, standard operating procedures (SOPs), working practice/working instructions, and training materials.Effective organizational and time management skillsDemonstrated ability to implement projects of strategic importance, including managing multiple projects simultaneously.Demonstrated success in delivering projects on time, within budget, and in accordance with strategic imperatives.Proven ability to exercise problem solving and strategic thinking skills; and has foresight and judgment in making complex decisions.Flexibility, the ability to adapt to changing project scope and direction; particularly as projects require strategic thinking and solutions.Self-motivated to drive for results, with strong organizational and planning skills.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Doctor of Pharmacy Degree (PharmD) or Scientific/Medical Degree5+ years of biotech/pharmaceutical/device industry experienceExperience with Veeva Vault (Veeva MedComms / Veeva Promomats) digital asset management systemExperience configuring/managing a database and working and partnering with IT colleagues to implement solutionsMastery of specific Project Management methodologies a plus (e.g., Lean, Six Sigma, PMP certification, etc.)Experience working in Medical Review Committee OperationsExperience developing Policies, Standard Operating Procedures (SOPs), Work Practice Documents, etc.Experience leading upgrade, implementation, or migration of new system/softwareAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Associate Director, Clinical Project LeadThis is what you will do:The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Associate Director, CPL may be accountable for setting and managing operations across multiple studies and may be a member of the Core Team depending on the scope of the project.You will be responsible for:Planning, implementing, and executing pivotal clinical trials, including study deliverables, milestones, and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors.Overseeing third party vendors to operationalize these study specifications.Directing the operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection.Planning, tracking, and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Developing and maintaining budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.Managing CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.Communicating clinical studies performance data to other members of the management and scientific team.Preparing and maintaining required study and regulatory documentation, e.g.: reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements, and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.Conducting lessons learned exercises to provide continuous process improvement and sharing of best practices.Participating in and/or lead departmental initiatives.You will need to have:>10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.Ability to lead cross-functional teams and to provide management oversight of CROs.Experience in developing study budgets, forecasting and financial oversight of a project.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Advanced degree (Master, PhD, MD) is desirable.PMP certification desirable.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

This is what you will do:The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes, and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources. You will be responsible for:Leading and managing team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Managing assignments and priorities of team members.Ensuring accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.Coordinating achievement of major statistical deliverables and milestones in collaboration with other functions.Leveraging standardization to maximize global data integration and interpretability.Providing statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.Providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.Applying innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)Keeping abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.Monitoring project progress and ensuring proper resource allocation for successful project deliverables against goals and timelines.You will need to have:A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experienceComprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive designregulatory requirements relating to clinical development of drugs and biologicsBLA/NDA experience including eCTD submissionsWorking knowledge of major statistical software programs including SASKnowledge of CDISC requirements for SDTM and ADaMExcellent verbal and written communication skills, and excellent inter-personal skills.The qualified applicant must also be flexible, well-organized, and possess the ability to work well under pressure.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:PhD in Statistics/Biostatistics preferred.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. #LI-MH1#LI-HybridDate Posted17-Nov-2023Closing DateAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law

This is what you will do:The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.You will be responsible for:Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members.Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.Leverage standardization to maximize global data integration and interpretability.Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.You will need to have:A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experienceComprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive designKnowledge of regulatory requirements relating to clinical development of drugs and biologicsBLA/NDA experience including eCTD submissionsWorking knowledge of major statistical software programs including SASKnowledge of CDISC requirements for SDTM and ADaMExcellent verbal and written communication skills, and excellent inter-personal skills.Flexible, well-organized, and possess the ability to work well under pressure.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:PhD in Statistics/Biostatistics preferred When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. #LI-MH1#LI-HybridDate Posted17-Nov-2023Closing DateAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law

This is what you will do:The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.You will be responsible for:Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members.Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.Leverage standardization to maximize global data integration and interpretability.Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.You will need to have:A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experienceComprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive designKnowledge of regulatory requirements relating to clinical development of drugs and biologicsBLA/NDA experience including eCTD submissionsWorking knowledge of major statistical software programs including SASKnowledge of CDISC requirements for SDTM and ADaMExcellent verbal and written communication skills, and excellent inter-personal skills.Flexible, well-organized, and possess the ability to work well under pressure.The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:PhD in Statistics/Biostatistics preferred .When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. #LI-MH1#LI-HYBRIDDate Posted17-Nov-2023Closing DateAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law

Associate Director (Human Factors Engineering)Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!At AstraZeneca, we put patients first and strive to meet their unmet needs 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.Summary of the group:The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.About the role:The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be a leader in the human factors engineering group. They will build strong relationships and collaborate with cross-functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use. Main Duties & Responsibilities:Proactive management of human factors engineering work across pipeline projects. Anticipate potential design/regulatory/quality risks, and develop actionable strategies following the latest industry and regulatory best practices and trends. Developing the strategy for and authoring Human Factors sections for health authority interactions and submissions. Interact with health authorities during face to face meetings and written responses.Lead human factors development activities for patient-centric device innovationsContribute to new product introduction efforts for parenteral combination product launch and on-market support by applying human factors principles and standard methodologiesCollaborate with external Human Factors consultancies and develop vendor strategy appropriate for the overall parenteral pipeline.Engage with AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and best practices.Lead, mentor and manage a group of HF engineers.Be a voice of user-centricity across all product types in AstraZeneca.Be engaged with and influence Human Factors best practices externally across industry and with regulatorsDevelop and find opportunities for improvement of internal Human Factors practices and associated business processes to ensure consistency, compliance and efficiency with internal business partners and counterpartsEducation & Experience Requirements:Education: Bachelor's or Master's Degree in human factors engineering, bioengineering, mechanical engineering, or related fieldExperience:Bachelor's Degree and 15+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development -OR- Master's Degree and 12+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development. Required Skills:Advanced knowledge in Human Factors engineering for combination products including a in-depth knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in the combination product space.Experience in health authorities (FDA, EMA, Notified Bodies, and other regulators) submissions and associated interactionsExperience with GxP responsibilities to provide applicable data and reports for health authority submissions and approvals. Familiar with health authority and quality audits.An understanding of the drug/device development process including a balanced perspective on how to integrate Human Factors work into these processes.Ability to build relationships with and manage external Human Factors consultancies to execute research activitiesStrong communication, organizational and technical problem-solving skills with an ability to influence internal stakeholders as well as external industry and health authoritiesAbility to lead a team, create a positive work environment and effectively develop staffWhy AstraZeneca?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 biopharmaceutical 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.When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Associate Director, AP Editorial Production College Board - AP&ILocation:This is a fully remote role. Candidates who live near CB offices have the option of being fully remote or hybrid (Tuesday and Wednesday in office). Type:This is a full-time positionAbout the TeamAP® is a rigorous academic program built on the commitment, passion, and hard work of students and educators from secondary schools and higher education. With almost 40 courses in a wide variety of subject areas, AP provides willing and academically prepared high school students with the opportunity to study and learn at the college level. The AP program is rapidly expanding its development of instructional and assessment products under the leadership of the growing Assessment Production team. The team currently consists of 18 talented and collaborative professionals with expertise in a variety of domains that are integral to the assessment production process.To support the continued production of high-quality teacher- and student-facing materials, the AP Program is looking fill the role of Associate Director, AP Editorial Production.About the OpportunityThe Associate Director, AP Editorial Production will oversee project and process management for the various editorial reviews across all AP courses and products, maintaining and communicating detailed reporting and status tracking across a number of interdependent workstreams. Partnering with the AP Editorial team, AP content teams, and various other stakeholders, the Associate Director, AP Editorial Production will ensure that all assessment items undergo the rigorous vetting and editing processes that ensure a high-quality end product for AP teachers and students.As an Associate Director of AP Assessment Production, you are an integral member of the cross-functional team building and delivering AP Exams and Instructional resources. You are a collaborative, insightful, and highly-motivated professional, with a keen eye for detail and a passion for educational opportunity. You are not shy about digging into ambiguity and you are quick to propose more efficient ways of getting things done.In this role, you will:Build and maintain detailed editorial production plans across courses and products (40%)Develop and maintain detailed review schedules for all summative and formative assessments as well as other ad hoc editorial initiativesMaintain clear and up-to-date documentation of the status of all editorial deliverablesCollaborate with relevant CB stakeholders to refine and revise prioritization of competing deliverables, managing editorial team bandwidthCalculate copyedit needs across the AP Assessment Production team based on current and long-term projected schedules; compare copyedit capacity against projected needs and identify potential gaps in copyedit capacityOversee the timing of new course onboarding, including development of course-specific authoring / editorial guidelines in collaboration with relevant technology teamsManage all aspects of relevant editorial review processes (40%)Facilitate multiple levels of editorial review for all AP assessment products and resources, including training and management of outside vendors, where neededLead weekly stand-ups with the AP Editorial team, providing visibility into and accountability for current work status and upcoming deliverablesFacilitate resolution meetings to streamline feedback integration and ensure alignment and between editorial and content teamsServe as liaison between editorial and other teams to support the resolution of issues affecting the editorial quality of itemsBudget and track all costs in your purview and recommend efficient staffing and resourcing solutionsProcess Development and Improvement (20%)Integrate project management tools for editorial work with processes managed by other key stakeholders In the Assessment Production value chainCollaborate with peers and the broader Assessment Production team to document and iterate on current project management practicesCollaborate with Senior Director, Editorial Quality to define and uphold best practices, identifying process refinements that safeguard the editorial quality of all AP Assessment productsShare recommendations for process and tool improvements on an ongoing basisAbout YouYou Have:3+ years of relevant product and/or project management experience (required), preferably in the education industryStrong organizational and time management skills with a process-oriented mindsetHigh degree of personal ownership to consistently deliver results in a fast-paced environmentExcellent interpersonal, collaborative and communication skills; demonstrated ability to establish positive working relationships at all levels of an organizationAn ability to process and distill large volumes of data and draw insightful conclusions to drive decision-makingAn ability to embrace ambiguity and a willingness to dig into unfamiliar tasksBachelor's degree (required)Willingness and ability to travel domestically 1-2 times per quarterYou must be authorized to work in the USAbout Our ProcessApplication review will begin immediately and will continue until the position is filledWhile the hiring process may vary, it generally includes: resume and application submission, recruiter phone screen, hiring manager interview, performance exercise and/or panel interview, and reference checks. This is an approximately 8-week processAbout Our Benefits and CompensationCollege Board offers a competitive benefits and compensation program that attracts top talent looking to make a difference in education. As a self-sustaining non-profit, we believe in compensating employees equitably in relation to each other, their qualifications, their impact, and the relevant market.The hiring range for a new employee in this position is $56,000-$95,000.College Board differentiates salaries by location so where you live will narrow the portion of this range in which you can expect a salary.Your salary will be carefully determined based on your location, relevant experience, the external labor market, and the pay of College Board employees in similar roles. College Board strives to provide our best offer up front based on this criteria.Your salary is only one part of all that College Board offers, including but not limited to:A comprehensive package designed to support the well-being of employees and their families and promote education. Our robust benefits package includes health, dental, and vision insurance, generous paid time off, paid parental leave, fertility benefits, pet insurance, tuition assistance, retirement benefits, and moreRecognition of exceptional performance through annual bonuses, salary growth over time through market increases, and opportunities for merit raises and promotions based on increased scope of responsibilityA job that matters, a team that cares, and a place to learn, innovate and thriveYou can expect to have transparent conversations about benefits and compensation with our recruiters throughout your application process.About Our CultureOur community matters, and we strive to practice and improve our culture daily. Here are some headlines:We are motivated to positively impact the educational and career trajectories of millions of students a year.We prioritize building a diverse and inclusive team where every employee can thrive, and every voice is heard.We welcome staff to join any or all six of our affinity groups: ARISE (Alliance for Asian Retention, Inclusion, Success, and Engagement; DIASPORA (Alliance for Pan-African Success and Achievement); Pride (alliance for LGBTQ+ staff and allies); Resilience (alliance for Native staff and advocates); SALSA (Staff Alliance for Latinx Success and Achievement); and WIN (Women's Impact Network).We value learning and growth; we offer formal and informal ways to lead through your superpowers, sharpen your strengths, and meet your development goals.#LI-REMOTE#LI-NM1