Click column header to sort
The Regulatory Affairs Project Manager will support regulatory affairs in formulation and execution of regulatory strategy and authoring of regulatory documents for submission to various Health Authorities. This includes providing support for all activities related to Health Authority meetings, requests for information and other queries from Health Authorities and other Regulatory Intelligence activities. The Regulatory Affairs Project Manager will be responsible for interpreting regulatory guidances and relaying key points to regulatory affairs and senior leadership. This position is also responsible providing training and mentoring to junior staff.
The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders.
The Director, Regulatory Affairs also ensures that there is labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans and formulates regulatory labeling strategies for implementation of new and revised prescribing information.
The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products.
The AssociateDirector,CMC Regulatory - Devices will develop and implement Global Regulatory and Chemistry, Manufacturing and Control (CMC) Regulatory strategies for products, including drug/device combination products and companion diagnostics, from development through marketing approval for the US, EU and other markets. The incumbent will be responsible for regulatory leadership, preparation and support of US BLA and NDA regulatory submissions, and ensuring compliance to all applicable regulations and standards, with focus on CMC and with specific expertise in the device component of submissions and on drug/device combination product requirements.
The HR Operations & Systems Analyst (HROSA) will work closely with the HR Operations Manager to lead and provide support for different activities related to data management and process in all HR systems, ensuring compliance in all areas. The role will primarily assist with various HR data and operational processes, including audit and validation activities, analytics and metrics reporting, and other system and data special projects. This role will also get exposure and work on projects in many HR specialty areas as opportunities arise.
The HROSA will have the ability to operate autonomously, working both strategically and tactically to achieve results. The HROSA will have experience in collaborating with key stakeholders, leveraging systems, and analyzing/foreseeing downstream impact. This role is remote based with occasional travel to the Radius Health office locations in Boston, MA and/or Wayne, PA.
Radius Health, Inc. is more than just a biopharmaceutical company. We are a growth company with audacious ambition for ourselves, our teams and for the patients who take our medicines. Radius seeks passionate, dynamic team players, problem-solvers and risk takers. We reward both imagination and those who mobilize big ideas. At Radius, it’s about high-performing teams boldly engaging an ever-changing healthcare landscape to positively impact generations of families. Radius is seeking outstanding candidates across a range of commercial roles. Join our revolution.
The Account Specialist is responsible for understanding and identifying a customer’s needs, support pull-through activities relative to the customer strategy and market access, deliver sales results and ensure that Radius Health is viewed as a valued partner to healthcare professionals and their patients. The Account Specialist will develop superior product and disease state knowledge that allows them to engage in a clinical dialogue with healthcare professionals; and effectively educates on approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients.
Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases.
This role provides Quality Assurance oversight of Radius-sponsored clinical trials to ensure compliance with study protocols, regulatory requirements, Radius SOPs, and industry best practices.
Primarily responsible for inventory and standard costing of activities related to our manufacturing operations. Major responsibilities include developing and maintaining product and standard costs, calculating overheads, operational analysis and inventory valuation. This includes month-end financial closing, reconciliations and reporting.
The Cybersecurity Administrator will provide industry leading security expertise and guidance to our employees who work in a hybrid remote/office model. Candidate will be responsible to advance the existing cybersecurity program, manage the changing threat landscape and expand protection services. This new position will join a team of IT professionals providing innovative technology solutions across our business enterprise.
The Director, Logistics and Clinical Supply will be responsible for the logistical activities related to the movement of materials and supplies through Radius’s global supply chain, including: transportation and freight management of API, work-in-process, and finished goods for both commercial and clinical supplies. The successful candidate will build effective partnerships with key stakeholders, including Clinical Operations, Quality Assurance, Technical Operations, and external service providers (CMOs/CPOs/CROs). The candidate will be accountable for compliance of contractual obligations and key performance indicators for third party vendors.
Radius Health is looking for an experienced finance professional focused on the tax, treasury, and payroll functions.
The Manager, Tax & Treasury reports to the Corporate Controller and partners with Senior Management to ensure optimal tax decision-making, leads tax compliance and research, and manages tax requirements for independent and regulatory auditors. This role also manages the company’s cash requirements including cash forecasting, safeguarding company assets, and managing the company’s currency risks. Additionally, the Manager, Tax & Treasury will be responsible for providing leadership for the payroll function.
Radius Health, Inc. is seeking a GMP Quality Assurance Manager with experience in supporting GMP operations and compliance for solid dosage and/or drug/device combination products in accord with FDA CFR Part 4, 210 and 211, FDA 21 CFR Part 820, EU GMP Volume 4, ISO 13485, ISO 14971, ICH Q7, Q8, Q9 and Q10; performing in a fast-paced environment under tight deadlines.
The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. The incumbent will execute Quality Assurance and quality system activities with a focus on Radius’ late-phase development and commercial products, ensuring consistent application of cGMPs. Specifically, s/he will have responsibilities for execution of quality systems related to complaint management, complaint investigations, CAPA and deviation management and change management.
The Senior Manager, Government Pricing and Contracts administers Radius Health’s contractual obligations under the Federal Supply Schedule (FSS), Public Health Service Agreement (PHS), Medicaid Drug Rebate Agreement (MDRA), Medicare Coverage Gap Discount Program Agreement (Coverage Gap), and the TRICARE Retail Refund Pricing Agreement. The candidate also is responsible for accurately calculating the quarterly Non-Federal Average Manufacturer’s Price (Non-FAMP), annual Non-FAMP, annual Federal Ceiling Price (FCP) and the quarterly Public Health Services Price (PHS). He/she is responsible for calculating and submitting quarterly/monthly Average Manufacturer’s Price (AMP) calculation and quarterly Best Price (BP) and Unit Rebate Amount (URA) calculations. The Senior Manager also administers the Industrial Funding Fee rebate which entails the verification of the data, calculation of the rebate, and providing Accounts Payable with the check request to ensure payment is made on time. Coverage Gap and TRICARE rebate payments also fall within the responsibilities of this position.
Radius is seeking an enthusiastic individual able to manage projects in a fast-paced environment. The Director, Discovery Science Program Management will provide project management support to the DS team to successfully support the delivery of drug development projects. These responsibilities will include supporting development and execution of strategy, managing program plans, timelines, critical path activities and outside relationships to ensure seamless execution of the program. The Director, DS Program Management provide support and facilitate proactive planning, issue identification and risk management discussions with the team and Leadership to ensure successful and timely execution of programs. The Director, DS Program Management will ensure that the program strategy is clearly integrated into the project budget and operational plans. This role will also serve as the alliancce manager for key external collaborations and company partnerships and scientific advisory boards.
The Associate Director, Patient Access and Digital Innovation is a leadership and customer facing role; both internal and external. They are responsible for helping to ensure that appropriate patients have access to the Radius portfolio of products through Digital Innovation. This includes mastery of the patient fulfillment journey and thorough knowledge of the market access landscape. This individual reports directly to the Senior Director of Patient Access, Support and Digital Innovation.