Assists in providing technical expertise in developing specifications, complaint investigation, maintaining quality of existing products, and product improvement. Assists in brand protection by ensuring that food quality and safety standards are maintained throughout the supply chain. Essential Duties and Responsibilities: Ensures all new products are in compliance with food safety and food quality Assists with the: Approval of supplier food safety, consistency and reliability Projects such as preparation of specifications and communication to internal clients of qualification of products Sensory testing, process modification, specification alignment and development efforts Supplier communication, product auditing, continuous improvement initiatives, product optimization new product development and product complaint resolution Food safety and quality projects Education, Training, Skills and Experience Requirements: 3 years of experience in manufacturing or a chain QSR/CDR concept, with a preference for protein or dairy BS BA in a scientific discipline - food science, microbiology, chemistry, nutrition, or biology Experience with quality systems, GMPs, HACCP, auditing and specification writing Training or certification in areas of HACCP, GMPs and food facility sanitation Proficiency in food testing protocols, methodologies and microbiological issues in food Experienced in specification development and implementation
Requirements Advanced degree (PharmD, PhD) with at least three years pharmaceutical or related experience would be preferred Our pharma client needs a Medical Communications Specialist to work with team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database (product label, published and unpublished studies) to develop a medical/scientific response that is accurate, fair balanced, complete and delivered in a timely manner. Assist in staffing of the medical information booth according to the company policies and procedures. Assist in on-boarding and training of new hires.
Regulatory Affairs Project Manager Job – Medical Device Our client needs a Regulatory Affairs Project Manager to support Asia Pacific (Japan, China, South Korea and Taiwan) regulatory approvals for implantables. Comfort and experience working hands on with design and validation reports and other technical files is needed. Requirements Previous experience authoring or approving design and validation reports a plus (strong technical writing skills). Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred. Experience working with registration partners. 510(k) experience and PMA experience a plus. Major Duties The Regulatory Affairs Project Manager will report to the Manager of International Regulatory Affairs. Manage the preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications and annual reports; marketing applications and annual reports to US and international regulatory authorities. Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate. Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and management. In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in identified regions globally. In collaboration with the international regulatory team, manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis. Directly interact with regulatory bodies in the US and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible. Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate. Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams. Manage query resolution process using sound project management skills and to agreed upon timelines in collaboration with cross-functional technical teams. Coordinates with RA international staff and internal support staff to support basic file preparation as needed. Update departmental procedures Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication. The Regulatory Affairs Project Manager title is equivalent to the Principal Regulatory Specialist title.
Our pharma client needs two Sr.Clinical Operations Associates for a one-year contract. They will work with the Clinical Trial Manager and Operations Study Lead in the operational execution of assigned clinical studies. Requirements Science degree preferably in science or health-related field Previous experience of working on a clinical study Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based) Responsibilities Study Management/Conduct Phase The incumbent assists the CTM/OSL in: CRO oversight, database lock activities; regional study drug management; regional trial master file management; periodic review of protocol deviations; regional vendor management; and ensuring adverse event reporting. Close-Out Phase The incumbent assists the CTM/OSL in the following activities: supporting database lock activities; ensuring all regional documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. The incumbent is responsible for completing all required training to execute their job and maintain their training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.
A Project Planner is needed by our pharmaceutical client in Irvine, CA. This is a one-year on-site position. Requirements: Life science and/or business degree with at least 5 years of experience in the industry, preferably with a sponsor or CRO. MS degree and PMP certification desirable. Strong knowledge of and experience with clinical study/trial operations processes. At least three years of Project Management experience required. Overview The Contract R&D Project Planner is responsible for supporting Clinical Trial/Project Teams by strategically developing and maintaining clinical study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. This person will work in a team orientated environment and is empowered to drive clinical study activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements. Responsibilities Develop and maintain high quality, realistic, cross functional clinical trial plans from protocol concept through completed clinical study reports. The R&D Project Planner will develop the study timeline when the protocol concept sheet is available. Partner with Project Management, Drug Development Operations and Clinical Development to implement project strategies and improve efficiency by identifying and implementing new business processes. Partner with the Clinical Development lead, Drug Development Operations department and the study team to ensure timely delivery of all clinical study milestones. The R&D Project Planner will be expected to identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines. Responsible for arranging and leading discussions on the clinical study plans. Present clear clinical study plan reports to stakeholders. Partner with study team leaders to tactically drive critical path elements within the study. Work collaboratively with functional departments to reduce timelines for study start up activities. Operate within the Growth Product Flow (GPF) Governance Board model for Project communication and accountability,
Our client needs a MSL with Dermatology experience who lives in the San Francisco, CA area to cover the Northwest geography. Education and Experience • Advanced degree with health science background (Pharm.D, M.D., Ph.D, preferred) • Preferred minimum 3 year total specific industry experience (pharma, device, etc) and minimum 4 years post professional degree practice or relevant transferable experience (clinical practice, academic research, regulatory/scientific) • Experience in Medical Dermatology • Ability to travel 50-60% JOB SUMMARY: Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support initiatives in Medical Dermatology. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized . Works closely with other personnel to ensure information, education, and research needs of healthcare professionals are met and to ensure scientific and technical training needs of commercial organizations are identified and met Responsible for maintaining annual expenses within assigned budget parameters Responsible for accurate and timely documentation of above activities The employee must conduct their work activities in compliance with all internal requirements and with all applicable regulatory requirements. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. KEY DUTIES AND RESPONSIBILITIES: 1. Identify, develop and maintain professional relationships with thought leaders, academic centers and researchers in assigned areas of therapeutic interest to ensure access to current medical and scientific information on products. 2. Upon request, present data on products to healthcare professionals including physicians, academic institutions, researchers, and other health care professionals. 3. Support research initiatives as requested by R&D, Clinical Operations, and Medical Affairs Departments. 4. Serve as internal medical and scientific resource to assigned therapeutic areas for development of disease-state and product communications and materials that are medically accurate, balanced, and consistent with regulatory guidelines. 5. Support Round Table and Advisory Board sessions to ensure accuracy of scientific and clinical data. 6. Conducts on-going training to medical affairs, field sales and other internal personnel as directed. 7. May provide support for payer-facing activities to public and commercial managed markets. Essential Skills and Abilities • Knowledge of applicable pharmaceutical industry legal and regulatory guidelines • Proficiency in Excel, Word, Power Point and other software skills • Conveys information clearly, using a variety of media, to individuals and groups • Excellent written/verbal communication skills • Strong interpersonal skills • Strong presentation and teaching skills • Ability to convey clinical and non-clinical technical information effectively • Ability to engage the audience and help them understand and retain information • Ability to learn clinical and non-clinical technical information • Ability to work independently and in a team structure • Demonstrated success at maintaining effectiveness when experiencing major changes in work tasks or environment • Ability to adjust effectively to work within new structures, processes, requirements or cultures • Strong planning and organizational skills • Strong team and leadership skills
Grow your career while working and being trained in the exciting field of Oncology Clinical Research. This opportunity is for a large growing clinical trial site in W. Los Angeles. Requirements: *Experienced Oncology Nurse (RN required, OCN is a plus) *CA License *Must be able to follow the protocol and see that it is followed *Good communication skills and work well with patients and doctors *Full-time Mon-Fri *Must be commutable to W. Los Angeles Responsibilities may include: • Screening patients for inclusion/exclusion criteria for the clinical study • Consenting patients • Reviewing and/or reporting adverse events • Reviewing con-meds • Physical exams with the Dr or NP • Communicating with the Sponsor and the Clinical Research Associate • Nurse will be managing 10-12 study protocols • Collaboration with other team members (including data managers, CRC's, radiologist, PI's, etc.)
Are you looking for a rare, ground floor opportunity to join a dynamic, rapidly growing, privately owned company? Our client has an immediate need for a Vice President of Genomic Research. Reporting directly to the CEO, the VP will lead the Genomics Research group. The "ideal candidate" will: Have experience leading development and validation of a multiplex genomic test Bring a strong background in immunology, blood based genomics, and computational biology Direct and ensure execution of studies for molecular diagnostic products Have expertise in designing the test development process Be knowledgeable in US and international clinical regulations Have directed teams including: molecular biologists and clinical scientists Enjoy working in a fast paced, collaborative environment Requirements include: Masters, PhD, or MD in a related field Strong knowledge of both FDA and internal regulations Minimum of 5 years hands-on managerial experience Successful track record developing and leading multi-disciplinary teams Basic understanding of statistics and statistical methods In-depth knowledge of experimental design Strong communication skills; ability to interface with internal and external departments Qualified candidates are invited to contact Emily Outhwaite at MEIRxRs to schedule a confidential discussion. Work: 928-213-9400 Cell: 928-607-5981 Email: firstname.lastname@example.org