81 jobs found

PricewaterhouseCoopers Line of Service: AdvisorySpecialty/Competency: Data and Analytics TechnologiesIndustry/Sector: HI X-SectorTime Type: Full timeGovernment Clearance Required: NoAvailable for Work Sponsorship: YesTravel Requirements: Up to 80%A career in our Business Intelligence practice, within Data and Analytics Technology services, will provide you with the opportunity to help organisations uncover enterprise insights and drive business results using smarter data analytics. We focus on a collection of organisational technology capabilities, including business intelligence, data management, and data assurance that help our clients drive innovation, growth, and change within their organisations in order to keep up with the changing nature of customers and technology. You'll make impactful decisions by mixing mind and machine to leverage data, understand and navigate risk, and help our clients gain a competitive edge. Creating business intelligence from data requires an...

Biogen Job DescriptionPrincipal Accountabilities:* Work closely with the US Regulatory Lead (USRL) for a given program(s) and contribute to RPTs.* Participate on cross-functional project teams on an agenda driven basis and support the USRL in presenting the US regulatory perspective to the cross-functional project teams, and to senior management governance committees as needed.* Act as a core member of the US Labeling team and work collaboratively with the team to ensure implementation of the US Label, which includes providing guidance regarding US labeling precedence to the cross-functional teams.* Responsible for interfacing with Regulatory Operations to support various submissions to the FDA in support of investigational applications and/or marketing authorizations.* Support the USRL and cross-functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and...

Biogen Job DescriptionThe Associate Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including:Review and analysis of safety data from post-marketing sources and from clinical trials; the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor.May represent Biogen Drug Safety and Risk Management at internal and external meetings.Additionally, the MD can be appointed as the Global Safety Officer for a specific compound / product.The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who...

Biogen Job DescriptionThe Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Acts as the primary point of contact for regulatory functions (i.e. GEM, CMC, Development, and Labelling) as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality. Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.Principal Accountabilities:Driving change, responsibility for a wide range of initiatives / relationships, as well as process...

Biogen Job DescriptionThe Associate Director, Pharmacovigilance Quality, provides direct supervision to GSRS Quality Managers and/or Associates to set GSRS strategy and oversee day-to-day tasks related to GSRS compliance, audit and CAPA activities. This position will also partner with GSRS staff located at Biogen's Affiliate offices and assigned process owners within R&D to work as their quality resource to manage quality issues, process improvement opportunities and other quality related tasks. This role will collaboratively manage the GSRS audit and inspection readiness activities, for their assigned areas, and work with Pharmacovigilance subject matter experts (SME) to evaluate systems for compliance, prepare SME for audit interviewing, and create storyboards. He/She is responsible for managing the GSRS audit response process. This position will also oversee the GSRS compliance activities including metric development. This position may also be required to perform other...

Biogen Job DescriptionThe Director, Global Regulatory Strategywill be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China). Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.II. Duties and Responsibilities:A. Essential Functions:* Responsible for directing global regulatory strategies for assigned projects and programs.* Direct global clinical and pre-clinical regulatory strategies.* Direct global life cycle management of products.* Support development of the late stage...

Biogen Job DescriptionThe AD, Global Regulatory Strategywill be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsibility of leading the regulatory strategy for the development of an immunology asset/s across multiple indications and/or development of late stage neurology asset/s. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China). Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committeesII. Duties and Responsibilities:A. Essential Functions:* Responsible for directing global regulatory strategies for assigned projects and...

Biogen Job DescriptionThe Senior Manager of the Biogen Library and Information Center directs all operations, team management, strategic vision, communication and functions of the library, ensuring consistent delivery of services, tools, and data resources.Establishes and owns the strategic direction for the BLInC organization, executes the annual strategy and vision in alignment with R&D and corporate goals. Identifies organizational library and information needs, defines strategic priorities and tactics required to meet these needs. Demonstrates thought leadership to raise the profile BLINC across the organization.Hires, trains, supervises, and manages library team. Manages team members including defining annual goals and targets in alignment with company and department goals, planning and delegation of projects; and supporting professional development and continuing education for all team membersManages global online information portals and systems, including assessment,...

Biogen Job Description**This global position can be based in one of Biogen's locations: Cambridge, MA or Maidenhead, UK**This role is responsible for the development, implementation, and oversight, of global regulatory CMC (RegCMC) systems and tools. Responsibilities include learning, influencing, and preparing for the application of new and future tools, systems, and information management technologies. This candidate must have proven leadership and abilities to work cross-functionally and cross cultures. Strong communication and interpersonal skills are required. The role is situated within the 'Global regulatory CMC Strategic Operations' team that supports a global department of ~50 in all strategic operations work. The focus of this role will be on the regCMC strategy and functional support for information technology. Close partnership with the regCMC IT lead will be essential and support from this lead will be available for the technical IT aspects.Duties and...

Biogen Job DescriptionThe Senior Directorof Medical Writing and Labelingprovides leadership and oversight for the medical writing and labeling functions including strategic direction for the functions and building the functions to meet and anticipate Biogen's business needs. Provides strategic direction and guidance on medical writing documents and labeling to meet regulations and the global needs of Biogen. Partners with R&D departments to ensure milestones are met for development and marketed products throughout their lifecycle.Functions as a strong people manager and technical leader, with demonstrated management, scientific, and customer-focused leadership skills. Provides mentoring and career development to direct reports to create a high-quality and productive group. Needs to have knowledge of requirements related to clinical regulatory documentation, Target Label Profiles, and Core Data Sheets to support all phases of clinical development (Phase 1-4). Liaises within...

Biogen Job DescriptionThe Director Global Submission Planning & Resource Management is responsible for leading the Planning & Resource Management Function and planning related activities for GSRS.This role is globally accountable for providing a Global submission planning for major submissions (e.g. MAA, NDA, BLA, INDs) and Post-Approval changes (e.g. Variations, NDA's,and Line Extensions) for Biogen's product portfolio.This role is globally accountable for resource capacity and management for GSRS to determine resource constraints and operational high demand utilizing Biogen's Clarity System Oversees vendor relationships including determining outsourcing model, yearly operating budgets, resource allocation, and support model.Develop and manage budgets related to Annual Operating Plan (AOP) including purchase orders and contracts.#LI-TD1QualificationsLeadership for Submission Planning:* Accountable for the planning, managing, and tracking of the regulatory portfolio of...

Biogen Job DescriptionThe Associate Director, Medical Writing provides leadership and functional oversight for one or more clinical program. This person functions as a strong project manager and technical leader, with demonstrated scientific and customer-focused leadership skills. They will direct medical writers in the preparation of clinical regulatory documents, including clinical summaries/overviews for marketing applications (including global markets and emerging markets) and clinical trial applications (INDs/CTAs). Will also partner with R&D departments to ensure timely completion of high-quality clinical regulatory documents. The AD, Medical Writing is required to have expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4), and acts as a medical writing subject matter expert to other departments.This person will provide mentoring and career development to direct...

Biogen Job DescriptionThe Principal Medical Writer will be responsible for providing medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials.This position interacts with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., SMT, CDT, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. Leads cross-functional team and drives decision making. Leads strategy-related discussions related to document development. Identifies areas for process improvements within and without department and leads discussions to implement change. In addition they will also:-Independently preparecomplex clinical documents; independently coordinatepreparation of clinical documents for regulatory submissions and/or publication strategies for one or more programs;-Represents department on clinical...

Biogen Job DescriptionOversee the Global Clinical Operations IT organization and business relationships. Serve as the IT strategic partner and primary liaison for the GCO Business Process Management organization. Manage all GCO IT related projects across various business units. LeadsR&D IT Development portfolio management and teamswithin theDevelopment. Work closely with the GSRS IT, Regulatory IT and ADS IT organizations. Accountable for keeping Biogen's GCO IT regulatory and compliance standards in the regions/countries. Provide IT service management needs for the GCO Platform Champion of communication between the GCO, ADS, TCoe, ITQ, Research IT and IT.Key Responsibilities:Translating: Understand GCO business function and strategy and effectively translate IT strategies into opportunities and requirements for technology solutions.Anticipating/Influencing: Proactively anticipate business needs to shape demand for GCO IT services.Strategic Planning: Develop functional...

Biogen Job DescriptionThe US Regulatory Lead (USRL) is responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products. The USRL is a critical member of the Regulatory Product Team (RPT) providing US focused product strategy, US regulatory framework knowledge, and awareness of external regulatory initiatives. Also, serves as the single point of contact for R&D and the US business on regulatory issues for development and marketed products. The USRL partners with the Global Regulatory Lead (GRL) and will participate on cross-functional project teams representing Regulatory on an agenda driven basis. The USRL will present the US regulatory position on assigned products to senior management governance committees as needed. Externally, the USRL will actively participate and/or lead a variety of US focused Trade Association initiatives, Professional Associations and other NGOs.Principal Accountabilities:* Core member of the RPT...

Biogen Job DescriptionLeadsR&D IT portfolio management and teamswithin theResearch function. Shape and develop the teams to deliver complex projects and programsacross the prioritized portfolio. Manage and ensure predictable delivery of projects and/or programs - driving accountability of work stream owners and enabling escalation of risks and issues that require assistance or attention. Ensure resources, either internal or external, and funding are secured through high quality business cases to meet project needs. Ensure projects are delivered at a high level of quality according to committed scope, approved budget and targeted dates. Lead various program governance meetings including routine core teammeetings, as well as escalation andsteering reviews. Demonstrates thought leadership with business partners to shape/influence the portfolio and to ensure delivery of the most effective solutions for the identified and prioritized business objectives. Enable and enhance cross...

Biogen Job DescriptionThe Sr Director, Global Regulatory Portfolio Lead (GRPL) will be the principle regulatory representative for the Neuromuscular Therapeutic Area and oversee the portfolio from a strategic and technical perspective including direct project responsibilities as applicable. The GRPL will provide strategic guidance to projects and products through the supervision of global regulatory leads and regulatory strategists directly reporting to him/her. The GRPL is responsible for overseeing the development and delivery of innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. The candidate will be responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. They will also represent the company with health authorities, contractors and corporate...

Biogen Job Description**This global position can be based in one of Biogen's locations: Cambridge, MA, RTP, NC, or Maidenhead, UK**This role is responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals with a focus on development programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule, oligonucleotide projects or devices, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.This is a dual role of the CMC GRL and the CMC Regional Regulatory Lead (CMC RRL) in the region in which the CMC GRL is located. In addition to the accountabilities and responsibilities presented, the CMC GRL also assumes the role and responsibilities of the...