Medical Writer & Clinical Specialist job in Sylmar, CA
Vacancy has expired
Sylmar, CA CorTech LLC
| Job Ref: | 343487 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 108.69/Per Hour |
| Remote: | No |
Location |
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| City: | Sylmar, CA |
| Post Code: | 91342 |
| Map: |
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Description |
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CorTech is seeking to hire a Medical Writer & Clinical Specialist, for our client in Sylmar, CA! Benefits Available! Weekly Pay! $108.69/Hour Start Time (AM/PM) 8:30am End Time (AM/PM) 5pm Exempt/Non Exempt: Non Exempt Years Experience: 7+ Skills: Experience with presenting results of projects both internally & externally; present complex technical data to large and diverse groups. Ability to train others on the theoretical and practical basis of techniques, processes and assays. Familiar with project planning, process updates, & experimental design Prepares & align impact goals with department goals. Education: Ph.D. in a life or physical science preferred with up to two years research or industrial experience or BS/MS degree with additional progressive research experience sufficient to demonstrate equivalency. Duties: Conceive, plan, design & conduct advanced independent research in compound, assay, process, product, or method development. Direction is provided by project goals & experimental design. Interact with other groups and share information; participate in team activities. May act as lead scientist, project leader, or project contributor. Provide technical direction and feedback to others. Directly supervise technical personnel. Responsible for implementing and maintaining the effectiveness of the quality system. Design, plan & execute project related tasks. Design experiments to test hypothesis related to project outcomes. Apply advanced scientific knowledge to projects; determine priorities for experiments. Independently design and execute experiments. Utilize DOE as appropriate. Assure experimental quality through sound, independent experimental design. Identify technical alternatives from literature review. Familiar with lab environment & safety practices: may assume roles of responsibility (i.e. Safety Officer, Emergency Control Force delegate, etc.). Apply basic computer skills. (Includes word processing, spreadsheets, instrumentation related & Abbott network systems.) Apply advanced technical writing skills to produce reports & documents; write independently, evaluates the writing of others. Utilize numerous analytical instruments; train others in their operation. Recognize & resolve technical problems. This role is specific to EU Medical Device Regulation (MDR) post market clinical follow up (PMCF) planning and reporting. Must feel comfortable collecting, analyzing, and writing up data into reports, as well as planning for future data collections. Will act as Clinical Affair's representative to cross-functional meetings for regulatory submissions. Must be comfortable developing and managing timelines for deliverables and interfacing with cross-functional teams on a a regular basis. Productive, analytical physician with 12+ years? extensive experience in phase I, II, III, and IIII in clinical trial administration, management, pharmacovigilance as well as strong medical therapeutic knowledge in pulmonary/respiratory diseases and management in collaborating with pharmaceutical industries & Academic centers. Focus on Best medical practices, Clinical research (50 + clinical studies, Publications, and poster presentations) Expert knowledge of GCP, Protocol Design, Enrollment Strategies, Clinical Trial Reports, Clinical Site Binder, Investigator Brochure, Data Management, SAE reconciliation, EDC (Oracle, Medidata Rave and Red Cap), electronic trial master file system (Trial interactive) Safety Database and Microsoft Office, GVP and FDA clinical trial guidelines, EUMDR Medical Writer. Dedicated individual reputation for consistently going beyond what is required. Networking and entrepreneurial spirit compliments to core strengths such as self-motivated, trustworthiness, team player with integrity, willingness to succeed, and ability to influence with attention to detail, including strong computer, analytical, written, and interpersonal skills. Education & Training M.B.B.S. (Bachelor in Medicine & Bachelor in surgery) M.P. Internship: Hospital Residency: M.D.in Anaesthesia As Medical Writer & Clinical Specialist, duties include coordinating and administering research study associated activities effectively and efficiently as below: Prepares clinical research documents to support EU MDR registrations for medical device product lines including literature reviews, clinical evaluation plans (CEPs) and reports (CERs), post-market clinical follow-up evaluation reports (PMCFERs), summary of safety and clinical performance (SSCPs) and other clinical documents as needed. Utilize software to support the core process steps for systematic literature reviews (e.g. Distiller) Understand, interpret, and summarize complex results from the scientific literature including statistical results of clinical studies; present results in a clear, concise, and scientifically accurate manner for end users (e.g., regulatory bodies, etc.) Collect and compile available clinical evidence for EU MDR related CER updates (clinical study outcomes, post-market surveillance data, PMCF activity updates, etc.) Completes document format, content, and layout according to EU MDR compliant templates. Ensure maintenance EU MDR clinical documents in a document control management system (e.g. Agile). Communicates with other medical writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, risk management, product safety, etc. to correctly incorporate technical content and new EU MDR requirements. Assist/lead literature searches (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation Incorporate text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner. Medical Writer & Clinical Specialist Prepares clinical research documents to support EU MDR registrations for medical device product lines including literature reviews, clinical evaluation plans (CEPs) and reports (CERs), post-market clinical follow-up evaluation reports (PMCFERs), summary of safety and clinical performance (SSCPs) and other clinical documents as needed. Communicates with other medical writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, risk management, product safety, etc. to correctly incorporate technical content and new EUMDR requirements. Assist/lead literature searches (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation Utilize software to support the core process steps for systematic literature reviews (e.g. Distiller) Understand, interpret, and summarize complex results from the scientific literature including statistical results of clinical studies; present results in a clear, concise, and scientifically accurate manner for end users (e.g., regulatory bodies, etc.) Collect and compile available clinical evidence for EU MDR related CER updates (clinical study outcomes, post market surveillance data, PMCF activity updates, etc.) Incorporate text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner. Completes document format, content, and layout according to EU MDR compliant templates. Ensure maintenance EU MDR clinical documents in a document control management system (e.g. Agile). Ensure documents are produced in accordance with procedures, internal and external guidelines (e.g. EU MDR, MEDDEV 2.7/1 Rev 4) and electronic templates. Maintain compliance with corporate policies, state, federal and international regulations. assists in the planning and execution of medical writing activities related to the implementation of EU MDR including systematic literature reviews, Clinical Evaluation Plans (CEPs) and Reports (CERs), Post-Market Clinical Follow-up Evaluation Reports (PMCFERs), and other clinical research documents for assigned therapeutic area and projects. Senior Specialist, Regulatory Affairs Develop, implement, communicate, and maintain global regulatory strategies and plans Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission Review and approve device design control deliverables, as applicable per internal policies and procedures Review standards and guidance for applicability; assist in establishing regulatory positions and communicating these to relevant stakeholders Perform change management assessments; determine and communicate post-approval reporting requirements Develop and support implementation and maintenance of regulatory processes Lead and perform internal policy reviews for global regulatory guidance and regulations Contribute to and participate in internal and external education and training activities Identify and communicate relevant guidance, policies, standards, and regulations Build and maintain effective relationships with internal and external stakeholders Interface with regulatory authorities on regulatory and technical matters Create and update Operating Procedures and policy guidelines Review of product and labeling changes, advertising, and promotional activities Senior Specialist, Regulatory Affairs Interpreted and compiled domestic and international regulatory submissions for creation and maintenance of technical files. Participated in FMEA activity, ECN Review, Labeling Reviews and Design Reviews. Served as regulatory contact for internal departmental audits and audits by third parties (BSI, FDA, Etc.) Reviewed regulatory, marketing, and engineering materials in new product release, product labeling and market release activities, including review of Design History Files (DHFs). Participated in project team efforts by determining regulatory strategies. Set work direction/guidance to group of 4 regulatory affairs specialists, associates, and consultants Senior Specialist, Regulatory Affairs Contributed to the FDA regulatory submission process and authoring and publishing electronic submissions. Developed dossiers for registration of products in countries outside the US. Setting regulatory direction and strategies to development project teams for new and modified products. Reviewed proposed product changes for impact on regulatory status of the product. Evaluated risk of proposed regulatory strategies and offer solutions Manager, Global International Trade Compliance Oversaw and managed company?s international trade compliance program, working with multiple global functions and entities and serving as the trade compliance liaison to ensure compliance with US and international regulations. Offered guidance and support to Management and other cross functional groups of the company including regulatory, purchasing, legal, shipping/receiving and engineering to accomplish international Trade Compliance requirements. Specialist, Regulatory Affairs Planned and compiled submissions to obtain regulatory approvals for new and modified medical devices in region specific markets - US, EU, EMEA, Latin America and APAC. Served as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor. Advised product development team on global regulatory strategy for new products, work with product managers to globally register new and existing products. Communicated with the regulatory authorities on regulatory requirements and ongoing submissions. Professional Memberships & Certifications M.C.I (Medical Council of India) ACPR (Association of Clinical Research Professionals) PAH (Pulmonary Arterial Hypertension association) ECFMG (Education Commission of Foreign Medical Graduate) certified MCI (Medical Council of India) Certified as practicing physician. ACLS (American Cardiac Life Support) certified expired in GCP, and ICH training certified. CITI Good Clinical Practice certified. ACRP (American Clinical Research Professional) certified. International Air Transport Association (IATA) certified EU Medical Device Regulatory Affair certified | |
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1110 days ago
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