New York Classifieds > Jobs > Management

pPartial Job Descriptionp p1 Provide global leadership on CMC regulatory issuesp p2 Prepare plan, coordinate, assemble, review the CMC documents for submissions in the US and worldwide in support of both marketed products and research projectsp p3 Maintain Regulatory CMC existing products in the US and worldwidep p4 Review and approve documentation such as Log sheets, Change control form, testi...

pPartial Job Descriptionp p1 Provide regulatory strategic input and ability based on regulatory guidance and experience to global project team on assigned projectsp p2 Prepare routine submissions such as investigator submissions, adverse experience reports within INDs, NDAs, BLAsp p3 Prepare, review and compile files and reports for submission to global regulatory authorities, including FDA, EM...

oordinate activities associated with back room preparation six Ensure timely follow up and closure of all 483 commitments and other regulatory observations seven Audit and assess independently, quality management systems of suppliers and CMOs to ensure compliance with FDA 21 CFR Parts 11, 210, 211 and 820, ICH guidelines, ISO and other applicable regulatory qualifications eight Provide ongoing ...

ing companies on associated projects and will assure adherence to GCPs. three Requires substantial responsibility for implementation and follow-through of decisionstasks dictated by Project, Project Team and manager of Clinical Operations. four Performance of this position mandates a min of 15-25 travel to investigational sites, other company locations and CROs. 5 The Project Manager is respons...

udies Phase IIIb-IV as required, based on imaging and product qualifications three Provide medical support to Regulatory Affairs, including preparation of regulatory documents for new and established products four Provide support to medical operations, including input for selections of investigators, scientific and medical support for investigator meetings and investigator training sessions, me...

ram. three Change control administration for all systems requiring change control support e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods. four Maintain change control electronic records in the companys ERP system. five Review, assess,...

e study specific documents such as but not limited to investigator notebooks, case report form completion manuals, drug dispensing instructions and training slides 4 Ensure contacts and qualify study investigators and staff to perform clinical trials five Supervise clinical research activities performed by vendors conduct pre-study meeting, oversee monitoring of investigational sites and perfor...

and statisticaldata analysis plans for pre-clinical and clinical T2000, MMMDPB DPB studies three Select, manage and monitor CROs conducting pre-clinical and clinical studies and prepare and review final report four Prepare pharmacologytoxicology and clinical sections of investigators brochures, INDs and NDAs five Ensure pre-clinical studies meet GLP qualifications and clinical studies meet GCP ...

nal relationships with all types of obstetric caregivers five Provide caregivers with complete details pertaining companys banking to ensure the max number of enrollments to achieve the full business potential of the territory six Manage sales, marketing feedback and customer satisfaction relative to sales activities seven Invest the time and effort to achieve the established goals for the terr...

Partial Job summary one The Director of Immunobiology and Pre-clinical Applicant Evaluation has overall responsibility for the thorough assessment of innate and adaptive immune responses elicited by the array of vaccine applicants that are developed by the companys Vaccine Development Team, in addition to those co-developed with a network of external collaborators. two Lead the establishment, a...

bmissions i.e. INDs, NDA, MAAs International Registration Dossiers, supplements, amendments and variations three Liaise with the FDA International regulatory agencies throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc. four Oversee production of associated records of regulatory meetings that will be require...

Partial Position summary one Provide oversight, support and guidance in quality and regulatory issues two Oversee of quality qualifications in all areas three Manage national processes to meet FDA cGMP and FACT standards four Liaise with the corporate internal auditor program five Make recommendations and monitor current and future standards and implement training, procedures and practicesbr Mo...

ing with 3rd party contractors and External Partners to assure appropriate adherence to cGMP and Quality Systems are in place. two Develop and implement company quality strategies, policy and standards including guidance standards where necessary and manage company Quality Unit responsibilities and relations with external three Establishment of 3rd party Quality Agreements four Review and appro...

Partial Position description one Provide directions and support for development of new US products, for new indications for marketed products and life cycle medical management activities two Provide medical directions and support for Phase I-III clinical trials three Provide medical directions and support for market studies Phase IIIb-IV as required, based on imaging and product qualifications ...

Direct support the Label Free Interactions Analysis group LFIA and serves the US and Canadian markets four Collaborate together with sales, marketing and application scientists to ensure revenue targets to meet customer satisfaction five Provide critical and timely lead details to key stakeholders in field sales, sales operations and marketing six Expand the long term market opportunity for lab...

table working relationship four Ensure project management at a study level 5 Oversee management of CRO and staff six Ensure vendor management, including costbudget management seven Review all activities relevant to both single and multicenter clinical trials on daily basis eight Collect and review regulatory documents CV, IRB approval, licenses, financial disclosure, confidentiality agreement e...

medical device products four Establish and maintain the effectiveness of Quality Systems, including supplier selection, supplier qualification, quality agreements, supplier audits, supplier performance evaluation five Establish and maintain SOPs, work instructions, forms, templates and other documents associated with the systems noted above six Work collaboratively with other functions in the i...

harmaceutical and medical device products four Manage the handling, investigation and resolution of all product performance complaints and patient-related position events in a manner that complies with regulatory qualifications 21CFR Parts 210, 211, 820 5 Manage the process pertaining to contact with healthcare professionals submitting product complaints six Review completed complaint files to ...

plates and other documents associated with the systems noted above three Ensure Quality Systems are implemented and maintained in compliance with FDA 21 CFR Parts 210, 211 and 820 ICH guidelines and other applicable regulatory qualifications four Work collaboratively with other functions within BDI in the improvement and incorporation of industry best practices for the quality systems noted abo...

untry-specific or company-specific reporting offices in the applicable region four Developmanagereport status of the DSP unit budgeting, staffing and operations five Preparereview documentation and answer safety-related questions, when requested by specific local regulatory authorities in collaboration with GPSAE Global Product Safety Analysis Evaluation or SO Safety Operations, as needed six E...