02/09 | At EMD Serono, Inc. our strength is our people! About the Company EMD Serono, Inc. , an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a lead | | Rockland, MA, 02... | | map | | | action |
02/09 | The Regulatory Services Officer is responsible for performing a variety of administrative and analytical functions associated with implementing Defined Contribution plans, including preparing and negotiating the service agreements, and any ancillary documentation necessary for Putnam to contract with a client; implementing amendments; performing comprehensive reviews of plan documents for legal/op | | Andover, MA | | map | | | action |
02/08 | HAEMONETICS, THE Blood Management Company is a global leader engaged in the design, manufacture and worldwide sales and marketing of blood management solutions. Recognized as the innovator in blood technologies, our mission is to create innovative products, design information technology platforms and to provide consulting services to advance the safety, quality and availability of the world’s bl | | Braintree, MA, 0... | | map | | | action |
02/08 | Client seeking a global regulatory affairs dealing with drugs or biologics. Responsibilities: -Drafting and submission of clinical trial applications to global ministries of health -Research and presentation of country specific regulatory timelines, guidance’s and requirements to support global market expansion -Assisting global regulatory team in assembly and submission of global marketing applic | | Lexington, MA, 0... | | map | | | action |
02/05 | At EMD Serono, Inc. our strength is our people! About the Company EMD Serono, Inc. , an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a lead | | Rockland, MA, 02... | | map | | | action |
02/05 | Job Title: Manager of Regulatory Affairs (RM22-10) Reports To: Director, Regulatory Affairs Location: Boston, MA Area (LOCAL CANDIDATES ONLY) Compensation: $95,000 - $110,000 Benefits: Excellent benefits, including medical and dental coverage, flexible spending program; tuition reimbursement and 401(k) with employer match About our Client : A leader in the development, manufacture and distribution | | Boston, MA, 0211... | | map | | salary | action |
02/04 | We simplify healthcare by focusing on the people in the care cycle – patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in | | Andover, MA, 018... | | map | | | action |
02/03 | Sr. Manager/Associate Director, Regulatory Submission Management<br/>Location: Cambridge, MA<br/><br/> The Sr. Manager will be an integral member of the Global Regulatory Dossier Management Group. The Submission Manager will have overall responsibility for management of complex regulatory submissions, leading cross-functional submission teams for new drug applications (NDAs and MAAs) and investiga | | CAMBRIDGE, MA, 0... | | map | | | action |
02/02 | Medical Writer with Clinical / Regulatory Documentation Experience (Partial Telecommute) Keywords: documentation specialist, clinical writer, clinical data writer, AMWA, project manager, regulatory documents, regulatory medical writer, regulatory writer, regulatory documentation, clinical documentation, medical writing, IBs, CSRs, We are working with our client in locating 2 Medical Writers to wri | | Boston, MA | | map | | | action |
02/01 | Regulatory Submission Senior Manager The Submission Manager will have an opportunity to develop a wide-range base of skills in both regulatory affairs and submission management working as an integral member of the Global Regulatory team. Responsibilities: Manage/plan regulatory submissions Develop and submit filings according to processes and timelines Drive existing submission processes on multid | | Boston, MA | | map | | | action |
02/01 | Manager Regulatory Affairs - Device Manage the regulatory aspects of biotechnology derived projects & products, including major, complex applications submitted to regulatory agencies. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Responsibilities: Lead complex projects which require coordination of cross-functional resource | | Norwood, MA, 020... | | map | | | action |
01/29 | Manager Regulatory Affairs - Biologics The Regulatory Affairs Manager will lead sales and marketing compliance initiatives, manage adverse event reporting program, and provide review of quality systems programs and documentation to ensure compliance with statutory requirements. As needed, the manager will liaison between regulatory and other departments, The manager will also assist regulatory col | | Norwood, MA, 020... | | map | | | action |
01/29 | Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA. Position Description: Manages the publishing, transmittal, and archiving of regulatory correspondence and submissions in b | | Lexington | | map | | | action |
01/28 | JOB SUMMARY JOB SUMMARY The Manager, Regulatory Affairs Compliance will lead sales and marketing compliance initiatives, manage adverse event reporting program, and provide review of Quality Systems programs and documentation to ensure compliance with statutory requirements. As needed, the manager will liaison between regulatory and other Organogenesis departments, including but not limited to Ope | | Canton, MA, 0202... | | map | | | action |
01/28 | The Sr. Regulatory Affairs Specialist/ Project Manager will be primarily responsible for managing Biologics/Medicinal Regulatory Affairs requirements for product manufacturing and quality aspects. The individual will develop and implement regulatory strategies for Biologics and Devices through interface with FDA, International regulatory bodies, physicians, consultants, and internal team members. T | | Canton, MA, 0202... | | map | | | action |
01/28 | Manager, Global Regulatory Affairs, Contract Position Person with at least 3-5 years regulatory affairs experience dealing with drugs or biologics. Candidate would have prior experience with the regulatory aspect of global clinical trials (CTA, IMPD, etc.) from drafting of the application to the submission and approval of the application. Ideally, the candidate would have global marketing submissi | | Lexington, MA | | map | | | action |
01/27 | PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Manager will support our Genetic Screening Business that focuses on products targeted to improve prenatal, neonatal and child health. He/she will represent regulatory submissions on global cross-functional teams providing guidance on US regulatory requirements | | Waltham, MA, 024... | | map | | | action |
01/27 | Our client is a diversified bank seeks a senior Compliance professional. Responsibilities To support the Corporate Regulatory Risk and Compliance Management organization in the monitoring of regulatory/legislative changes which affect the bank. Provide oversight for the communication process for notification of regulatory changes to all levels within the organization including Executive Management | | Boston, MA | | map | | | action |
01/27 | The Sr. Regulatory Affairs Associate is responsible for independently performing multiple activities in support of the Cystic Fibrosis program and Regulatory Affairs initiatives. This individual may also participate on Regulatory subteams as a representative of the Regulatory Affairs function. Provides key input to business process development and acts as coach and mentor within the team. KEY RESP | | Cambridge, MA, 0... | | map | | | action |
01/25 | UTC Fire & Security, a global leader in fire safety and security, makes a real difference in people's lives around the world by helping to keep people and property safe. Whether you're a seasoned professional or just starting your career, we may have the opportunity you've been seeking to work in a dynamic, energetic environment! Marioff HI-FOG is the world's leading water mist fire protection tec | | Ashland, MA, 017... | | map | | | action |
01/22 | DePuy Mitek, a member of Johnson & Johnson's Family of Companies, is recruiting for a Regulatory Affairs Associate II, located in Raynham, MA. DePuy, Inc. - Develops and markets products under DePuy Orthopaedics, Inc., DePuy Spine, Inc., Codman & Shurtleff, Inc. and DePuy Mitek. Among these are products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal i | | MA | | | | | action |
01/21 | At EMD Serono, Inc. our strength is our people! About the Company EMD Serono, Inc. , an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a lead | | Rockland, MA, 02... | | map | | | action |
01/20 | DIRECTOR OF REGULATORY AFFAIRS (PHARMACEUTICAL) Our client is actively pursuing a Director of Regulatory Affairs due to a retirement that is set to take place in early March. They are a very prominent pharmaceutical company that has experienced ten consecutive years of double digit growth. This position will report to the Senior Vice President of Research and Development who has told Senior Human R | | ST. LOUIS, MO, 6... | | map | | | action |
01/20 | Medical/Regulatory Writing Team Leaders Needed Signing Bonuses & Relocation Packages Available Synchrogenix Information Strategies Inc. is seeking experienced medical/regulatory writers to serve as Team Leaders at our Boston, Massachusetts location. As specialists in developing global medical, regulatory, clinical, and scientific documents, we work with Fortune 500 clients to get pharmaceutical an | | Boston, MA, 0211... | | map | | | action |
01/17 | Outcome is the leading provider of patient registries, studies, quality improvement programs, and integrated technologies for evaluating real-world outcomes. The company has designed, developed, and managed more than 150 patient registries, including many of the largest and most well-recognized programs for disease outcomes, comparative effectiveness and patient safety, and maintains its own EDC s | | Cambridge, MA, 0... | | map | | | action |