Biogen
At Biogen, we develop, market and manufacture therapies for people living with serious neurological, autoimmune and hematologic disorders.
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Biogen Jobs

Manager, Medical Research Operations Study Management
SummaryBiogen Medical Research Operations (MRO) provides operational support for the execution of post-market research supported by Biogen. The MRO is part of the Medical Evidence, Research and Innovation function in the Worldwide Medical department.Job DescriptionThe Manager provides operational excellence and strategy as well as oversight for medical data generation projects. Study types include clinical, non-clinical, prospective, retrospective, clinical trials, patient registries, and real-world data analyses. Projects are conducted in collaboration with colleagues at Biogen headquarters, local affiliates, academic partners, and CRO vendors. The Manager serves as the operational partner in driving these data generation projects. The Manager will be accountable for assigned research programs. They will work in close collaboration with the assigned study lead, and will coordinate the study lead activities. Together they will leverage their expertise in study planning to define the parameters for partnership and collaboration agreements, and for vendor contracts. They will coordinate the various activities relevant to the given study type, and are accountable for the execution timeline. These activities may include study startup, ongoing execution, tracking, data lock, study report generation, and closeout. The Manager will also support the Director, Medical Research Operations Study Management, in driving process and procedural excellence in the conduct of Medical Research activities.Key responsibilities: * Drive all project management activities for assigned data generation program in the MRO Study Management group* Operationalize data generation projects in close collaboration with the Study Lead, including program strategy, review committee management, contracting, study management team leadership, publication support, document filings, milestone reporting, and budgeting* Enter regular updates into the clinical trial management system for departmental projects, and compile reports from the system * Support the Director, Medical Research Operations Study Management with tracking and updating of the medical dashboard * Act as a key point of contact between the Medical Research Operations group and patient registry stakeholders* Communicate with Medical Directors, Real Word Evidence experts, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility, and provide feedback for proposal improvementQualificationsThe qualified candidate will possess a track record of successful clinical / medical research project management in a life science or healthcare environment. Excellent written and verbal communication skills, and a demonstrated potential to continually grow into new responsibilities are needed. They must be self-motivated and able to work independently, but also recognize when to reach for assistance from other available resources to solve problems. Specific qualifications include:* Minimum of 7 years of clinical research experience that includes at least 5 years of CRO or sponsor Project Management. * Strong Project Management skills including risk assessment and contingency planning* High degree of learning agility and ability to absorb new concepts and information quickly* Possess a combination of critical thinking and operational know-how that enables efficiency. Exceptional problem-solving and troubleshooting abilities.* Demonstrated success in working independently* Strong written and verbal communication skills, and team leadership skills* Preference for experience with late phase and observational clinical research* Experience in a neurology therapeutic area preferred* Strong English language skills required, additional languages preferred.EducationBachelor's degree in a relevant discipline required, Master's preferred.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Manager, Medical Research Operations Study Management
SummaryBiogen Medical Research Operations (MRO) provides operational support for the execution of post-market research supported by Biogen. The MRO is part of the Medical Evidence, Research and Innovation function in the Worldwide Medical department.Job DescriptionThe Manager provides operational excellence and strategy as well as oversight for medical data generation projects. Study types include clinical, non-clinical, prospective, retrospective, clinical trials, patient registries, and real-world data analyses. Projects are conducted in collaboration with colleagues at Biogen headquarters, local affiliates, academic partners, and CRO vendors. The Manager serves as the operational partner in driving these data generation projects. The Manager will be accountable for assigned research programs. They will work in close collaboration with the assigned study lead, and will coordinate the study lead activities. Together they will leverage their expertise in study planning to define the parameters for partnership and collaboration agreements, and for vendor contracts. They will coordinate the various activities relevant to the given study type, and are accountable for the execution timeline. These activities may include study startup, ongoing execution, tracking, data lock, study report generation, and closeout. The Manager will also support the Director, Medical Research Operations Study Management, in driving process and procedural excellence in the conduct of Medical Research activities.Key responsibilities: * Drive all project management activities for assigned data generation program in the MRO Study Management group* Operationalize data generation projects in close collaboration with the Study Lead, including program strategy, review committee management, contracting, study management team leadership, publication support, document filings, milestone reporting, and budgeting* Enter regular updates into the clinical trial management system for departmental projects, and compile reports from the system * Support the Director, Medical Research Operations Study Management with tracking and updating of the medical dashboard * Act as a key point of contact between the Medical Research Operations group and patient registry stakeholders* Communicate with Medical Directors, Real Word Evidence experts, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility, and provide feedback for proposal improvementQualificationsThe qualified candidate will possess a track record of successful clinical / medical research project management in a life science or healthcare environment. Excellent written and verbal communication skills, and a demonstrated potential to continually grow into new responsibilities are needed. They must be self-motivated and able to work independently, but also recognize when to reach for assistance from other available resources to solve problems. Specific qualifications include:* Minimum of 7 years of clinical research experience that includes at least 5 years of CRO or sponsor Project Management. * Strong Project Management skills including risk assessment and contingency planning* High degree of learning agility and ability to absorb new concepts and information quickly* Possess a combination of critical thinking and operational know-how that enables efficiency. Exceptional problem-solving and troubleshooting abilities.* Demonstrated success in working independently* Strong written and verbal communication skills, and team leadership skills* Preference for experience with late phase and observational clinical research* Experience in a neurology therapeutic area preferred* Strong English language skills required, additional languages preferred.EducationBachelor's degree in a relevant discipline required, Master's preferred.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Analyst III, Materials
SummaryThis role leads all manufacturing planning and purchasing raw materials required to support the RTP Manufacturing Site. The incumbent is also responsible for supporting the monitoring of the manufacturing schedule and raw material inventory.Job DescriptionThe incumbent leads all manufacturing planning and purchasing raw materials required to support the RTP Manufacturing Site. The incumbent is also responsible for supporting the monitoring of the manufacturing schedule and raw material inventory. The incumbent collaborates daily with manufacturing, warehouse operations, Quality Control, and Quality to resolve raw material issues, scheduling conflicts, inventory levels, and delivery requirements. He/she issues the monthly retest/expired material report and holds monthly meetings to ensure raw materials are released to support manufacturing planned demand. The incumbent has a working knowledge of Oracle and/or SAP ERP systems and manufacturing supply chain experience. Responsible for formula/recipe creation and master data creation/enrichment in Oracle, as well as the creation/reconciliation of production batches as needed. The incumbent is also responsible for monitoring and tracking raw material usage and inventory levels, excel and obsolete analysis and forecasting, end of month report review, cycle count schedule creation, entering and completing raw material/API/Finished product cycle counts, and participating in tech transfers and bill of material development/maintenance.1.Review production schedules daily to coordinate manufacturing needs with the warehouse and dispensary to determine production activities that require entry/updating in OPM; Also, responsible for raw materials planning and inventory control activities (for raw materials and WIP inventory), including forecasted demand maintenance, safety stock/ROP levels, and the weekly management of ASCP purchasing suggestions.2.Responsible for tactical day-to-day raw material planning and inventory control activities including creation and allocation of raw material to batches for raw material movement and dispensing. Responsible for ensuring timely and accurate reconciliation of batches in OPM. Interacts with manufacturing to complete month end closing activities. 3.Revises and maintains SOPs, SLRs, Formulas, Recipes, Validity Rules, Production Rules, Warehouse Rules in OPM. Supports new item creation process and Master Data enrichment. Initiates and post weekly cycle counts and investigates discrepancies as needed.4.Responsible for reviewing raw material vendor change notifications for inventory impact and facilitation of cross-functions discussions, as required, to drive changes to closure and/or visibility of change or inventory impact.5. Supports tech transfers and the development/maintenance of manufacturing bills of materials, as needed, and ensures that the raw materials are procured and on-hand to support the manufacturing schedule. Analyzes data and creates the Expired and Obsolete report at pre-determined frequency.QualificationsMinimum 2 year of relevant experience and/or training in a GMP regulated industry or an equivalent combination of education and experience.Basic knowledge of best practices in a defined area of expertise. Working knowledge of manufacturing operations, scheduling and inventory control practices. Basic understanding of relevant industry issues. a good understanding of manufacturing scheduling, planning and inventory control, excellent communication and collaboration skills, abilities to manage complexity and manage multiple priorities, must be team oriented, has excellent written and oral communication skills, possesses basic manufacturing process knowledge and analytical skills to troubleshoot conflicts, possesses a general understanding of inventory controlEducationMinimum Bachelor's degree in Chemical/Biochemical Engineering, Supply Chain Management, or other related business/science/technical field or High School Diploma with relevant years of experience and associate applications, possesses general knowledge of other operational areas such as Manufacturing, QC/QA, Warehouse/Dispensary, Mfg Sciences and Procurement.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Analyst III, Materials
SummaryThis role leads all manufacturing planning and purchasing raw materials required to support the RTP Manufacturing Site. The incumbent is also responsible for supporting the monitoring of the manufacturing schedule and raw material inventory.Job DescriptionThe incumbent leads all manufacturing planning and purchasing raw materials required to support the RTP Manufacturing Site. The incumbent is also responsible for supporting the monitoring of the manufacturing schedule and raw material inventory. The incumbent collaborates daily with manufacturing, warehouse operations, Quality Control, and Quality to resolve raw material issues, scheduling conflicts, inventory levels, and delivery requirements. He/she issues the monthly retest/expired material report and holds monthly meetings to ensure raw materials are released to support manufacturing planned demand. The incumbent has a working knowledge of Oracle and/or SAP ERP systems and manufacturing supply chain experience. Responsible for formula/recipe creation and master data creation/enrichment in Oracle, as well as the creation/reconciliation of production batches as needed. The incumbent is also responsible for monitoring and tracking raw material usage and inventory levels, excel and obsolete analysis and forecasting, end of month report review, cycle count schedule creation, entering and completing raw material/API/Finished product cycle counts, and participating in tech transfers and bill of material development/maintenance.1.Review production schedules daily to coordinate manufacturing needs with the warehouse and dispensary to determine production activities that require entry/updating in OPM; Also, responsible for raw materials planning and inventory control activities (for raw materials and WIP inventory), including forecasted demand maintenance, safety stock/ROP levels, and the weekly management of ASCP purchasing suggestions.2.Responsible for tactical day-to-day raw material planning and inventory control activities including creation and allocation of raw material to batches for raw material movement and dispensing. Responsible for ensuring timely and accurate reconciliation of batches in OPM. Interacts with manufacturing to complete month end closing activities. 3.Revises and maintains SOPs, SLRs, Formulas, Recipes, Validity Rules, Production Rules, Warehouse Rules in OPM. Supports new item creation process and Master Data enrichment. Initiates and post weekly cycle counts and investigates discrepancies as needed.4.Responsible for reviewing raw material vendor change notifications for inventory impact and facilitation of cross-functions discussions, as required, to drive changes to closure and/or visibility of change or inventory impact.5. Supports tech transfers and the development/maintenance of manufacturing bills of materials, as needed, and ensures that the raw materials are procured and on-hand to support the manufacturing schedule. Analyzes data and creates the Expired and Obsolete report at pre-determined frequency.QualificationsMinimum 2 year of relevant experience and/or training in a GMP regulated industry or an equivalent combination of education and experience.Basic knowledge of best practices in a defined area of expertise. Working knowledge of manufacturing operations, scheduling and inventory control practices. Basic understanding of relevant industry issues. a good understanding of manufacturing scheduling, planning and inventory control, excellent communication and collaboration skills, abilities to manage complexity and manage multiple priorities, must be team oriented, has excellent written and oral communication skills, possesses basic manufacturing process knowledge and analytical skills to troubleshoot conflicts, possesses a general understanding of inventory controlEducationMinimum Bachelor's degree in Chemical/Biochemical Engineering, Supply Chain Management, or other related business/science/technical field or High School Diploma with relevant years of experience and associate applications, possesses general knowledge of other operational areas such as Manufacturing, QC/QA, Warehouse/Dispensary, Mfg Sciences and Procurement.All individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Medical Director, Progressive Supranuclear Palsy (PSP)-US Medical
SummaryAs a key member of the US Medical PSP and movement disorder diseases team within the US Medical Neurology function, the Medical Director is responsible for supporting the development and implementation of US medical strategy for the product.Job DescriptionA summary of specific responsibilities include, but are not limited to: -Drive and execute on the US medical strategy for PSP as aligned with global strategy * Serve as the lead US Medical contact for key functions (e.g. US Field Medical, Global Medical, Clinical Development, Epidemiology, Pharmacovigilance, Commercial, Market Access). * Lead US specific data generation projects to address identified medical data gaps. * Provide medical expertise to cross-functional teams. Represent US Medical at other cross-functional meetings as needed. - As a content expert, review abstracts, publications, medical information letters, internal/external educational materials, and other medical documents as needed. * Lead planning and content development for advisory board meetings and other US Medical initiatives. Present data at Medical advisory board meetings and medical trainings. * Collaborate with global, regional and/or affiliate medical to ensure all medical activities are aligned with global medical strategy and that Global Medical is sufficiently aware of the US-based insights and needs.Qualifications* Pharmaceutical industry experience required (3 years minimum). Relevant experience in Medical Affairs is required.* Experience with neurology, movement disorders (PSP/PD/other) and/or rare disease is a plus. * Launch experience is a plus* Ability to effectively operate in a highly matrixed organization. *Strong interpersonal, influencing and project management skills. * Ability to take initiative and solve complex and challenging problems. * Excellent communication (particularly both written and oral), leadership, and presentation skills.Education* MD preferred, PhD, or other advanced degree in the life sciencesAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
Medical Director, Progressive Supranuclear Palsy (PSP)-US Medical
SummaryAs a key member of the US Medical PSP and movement disorder diseases team within the US Medical Neurology function, the Medical Director is responsible for supporting the development and implementation of US medical strategy for the product.Job DescriptionA summary of specific responsibilities include, but are not limited to: -Drive and execute on the US medical strategy for PSP as aligned with global strategy * Serve as the lead US Medical contact for key functions (e.g. US Field Medical, Global Medical, Clinical Development, Epidemiology, Pharmacovigilance, Commercial, Market Access). * Lead US specific data generation projects to address identified medical data gaps. * Provide medical expertise to cross-functional teams. Represent US Medical at other cross-functional meetings as needed. - As a content expert, review abstracts, publications, medical information letters, internal/external educational materials, and other medical documents as needed. * Lead planning and content development for advisory board meetings and other US Medical initiatives. Present data at Medical advisory board meetings and medical trainings. * Collaborate with global, regional and/or affiliate medical to ensure all medical activities are aligned with global medical strategy and that Global Medical is sufficiently aware of the US-based insights and needs.Qualifications* Pharmaceutical industry experience required (3 years minimum). Relevant experience in Medical Affairs is required.* Experience with neurology, movement disorders (PSP/PD/other) and/or rare disease is a plus. * Launch experience is a plus* Ability to effectively operate in a highly matrixed organization. *Strong interpersonal, influencing and project management skills. * Ability to take initiative and solve complex and challenging problems. * Excellent communication (particularly both written and oral), leadership, and presentation skills.Education* MD preferred, PhD, or other advanced degree in the life sciencesAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations
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