Qualified person jobs in High WycombeCreate job alerts

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Product Safety Product Safety Risk Management MD Scientific/Technology Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. The Medical Safety Officer (MSO) - Post Approval Lifecycle Management (PALM) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. The MSO will report to the Portfolio Safety Head and oversee the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. Collaborating with relevant functions, the MSO will ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles and benefit risk of their products within the TA. The MSO will communicate potential and known risks, when appropriate, to TA Portfolio Safety Head, TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products. • Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)], as well as other activities related to managing the safety profile of assigned products., • Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams., • Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols., • Be an active partner and core contributor of safety input to key regulatory or clinical documents including: Risk management plans Safety development plan Clinical Trial Protocols Informed Consent Forms (ICF) Safety Sections of Investigator's Brochure (IB) and IB addenda Clinical Study Reports (CSR) Annual Safety Reports (ASR) Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR) Health authority queries Core Data Sheets (CDS), • Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC)., • Actively participate and contribute to meetings with Health Authorities and external key opinion leaders., • Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities., • Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products. This will include:, • Defining the safety question or issue requiring medical safety assessment, • Developing the strategy for the safety review and analysis, • Interpreting results and determining the medical importance of a question or issue, • Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports), • Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across cli #J-18808-Ljbffr

Video is one of the fastest-moving areas of our industry & one of the biggest growth opportunities in our business. LED is turning up everywhere: touring, broadcast, corporate, houses of worship, retail, film & virtual production. We're looking for a Business Development Manager to own that growth for us. This is a role for someone who knows the video market from the inside. Someone who has specified it, sold it or run it. You'll be the person our customers call when they're pricing up an LED screen, choosing a projector or trying to work out what processor will actually survive a 40-date tour. Developing new business across our video portfolio, including LED screen, video processing, projection, media servers & control, with rental & production companies, integrators, venues & end users. Growing revenue and margin from existing accounts and building relationships with the specifiers & technical decision-makers behind them. Acting as the commercial and technical bridge between our customers & our suppliers, including product introductions, demos & site visits. Working alongside our internal sales, project and technical teams to turn enquiries into specified & deliverable solutions. Feeding market intelligence back into the business — what's selling, what's coming, where the gaps are — to shape our product strategy and stockholding. Representing AC-ET at trade shows, open days, training events & customer premises across the UK & occasionally further afield. Proven sales or business development experience in professional video, AV or the wider entertainment technology sector. Solid working knowledge of LED display technology & video systems — pixel pitch, processing, signal distribution, calibration & rigging considerations. A track record of building long-term customer relationships rather than one-off transactions. Confidence presenting technical products to technical audiences. Full UK driving licence & a willingness to travel. Hands-on production or systems integration background Having an existing network within UK rental, production or AV integration Experience introducing new product ranges to market Company vehicle or car allowance Ongoing manufacturer product training across a leading brand portfolio Access to manufacturer training and industry-leading product from our supplier partners A business that's been supplying this industry for over 50 years, with the depth of stock, technical support and logistics to back up what you sell A.C. Entertainment Technologies is an equal opportunities employer and welcomes applications from all suitably qualified candidates. #J-18808-Ljbffr

This sessional post is for a GP with a special interest in gynaecology, sitting within the community gynaecology team at FedBucks, a GP federation. The work centres on clinics for heavy bleeding, pelvic pain, contraception and menopause, plus coil fitting and other procedures under consultant support. Four-hour in-person sessions run across several community sites, with a structured route to advanced procedures such as pessary fitting. Applicants need at least five years' post-qualification experience and a primary care background. • Run specialist gynaecology clinics to assess, diagnose and manage presentations, • Manage heavy menstrual bleeding and menorrhagia, • Investigate irregular bleeding and post-menopausal bleeding, • Manage chronic pelvic pain and endometriosis, • Manage polycystic ovary syndrome and hormonal imbalance, • Provide contraceptive counselling and menopause management, • Perform routine gynaecological procedures within scope of competence, • Carry out difficult IUS insertion, lost IUS removal, cervical polypectomy and difficult smear tests as training progresses, • Assess and manage prolapse symptoms with a vaginal pessary, • Work under consultant support, taking part in MDT discussions and clinical meetings, • Keep up to date in women's health and engage with clinic training and development, • Ensure the gynaecology service follows local policies and CQC requirements, • Qualified GP with completed gynaecology training certificate, • Evidence of postgraduate education such as MRCGP, DCH or DRCOG, • F2 supervisor training or teaching diploma, • DFSRFH and competence in gynaecology services, • Evidence of CPD activity, • Fully registered with the GMC and on the GP Register, • Minimum of 5 years post-qualification experience as a senior clinician in the UK, • Primary care experience, • Competent in IUS/IUCD insertion and removal (LARC), • Certified cervical smear taker, current with screening guidance, • Presentation, communication and coaching or mentoring skills, • Understanding of how primary care differs from hospital, and of vulnerable patient groups, • Knowledge of the NHS, CQC regulations and ERS access demand management, • Evidence of audit participation and experience supporting service change, • Enhanced DBS check before appointment, • Strong commitment to women's health and a desire to progress in the specialty, • Direct training and advice from experienced GPwSIs and consultants, • Training pathway to advanced procedures such as pessary fitting, cervical polypectomy and difficult coil insertion or removal, • Structured environment to maintain existing skills while learning new ones, • Multidisciplinary, supportive team culture, • Health and wellbeing programme #J-18808-Ljbffr

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at innovative-medicine We are searching for the best talent for a Submissions & Regulatory Intelligence Manager within Integrated Data Analytics & Reporting (IDAR), to contributes to the Clinical Data Standards team as an individual contributor and a developing subject matter expert, to take a leadership role in the collaboration with various internal and external partners. The Submissions & Regulatory Intelligence Manager provides expert guidance and implements tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. Foremost is ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements. This role may be located in High Wycombe/Maidenhead, United Kingdom; Beerse, Belgium; Allschwil, Switzerland; Leiden, Netherlands; or Spring House/Raritan/Titusville, United States (Hybrid / 3 days onsite per week preferred). Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium/Netherlands - Requisition Number: R-103242 United Kingdom - Requisition Number: R-101253 Switzerland - Requisition Number: R-103247 United States - Requisition Number: R-103251 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. • Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization, • Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements., • Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams, • Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards., • Coaches and trains junior colleagues in clinical data standards application and responsibilities., • Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making. The Submissions & Regulatory Intelligence Manager is responsible for providing significant expertise to the IDAR department (and GD if applicable) in clinical study data regulatory submission requirements and strategies. Examples of this content are: • Newly released or updated Regulatory Health Authority (RHA) and industry guidance documentation, • Identification of clinical study data submission information critical to IDAR submission processes and procedures, including providing an interpretation of such information if needed, • IDAR submission requirements and rules The position serves as the single Point of Contact for any stakeholder on data management, clinical and statistical programming, and global regulatory affairs, for data submission deliverable requirements and makes sure these teams have a very clear understanding of these deliverables, the need for compliance, the difference between RHA requirements and the general submission processes. The Submissons & Regulatory Intelligence Manager is responsible for acquiring and maintaining deep expertise in current RHA and industry guidance and RHA validation/compliance rules in relation to data submission packages (e.g., SDTM/ADaM submission packages). The position supports the ownership by SRI of any tools, system, checklists templates, etc., that facilitate data package compliance checking for IDAR. The position may serve as the lead of the Submission Center of Excellence, serving as POC for study teams requesting SubCOE support, responsible for workload distribution amongst the team, working at the trial level post-DBL to ensure SDTM, ADaM, and documentation submission-readiness. Are you ready to join our team? Then please read further! • A Bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD), • At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming!, • Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM), • Experience with regulatory submissions (NDA, BLA) is an asset, • Demonstrated written and verbal communications skills, • Demonstrated customer focus and solution-oriented experience, • Demonstrated interpersonal skills to build relationships with internal and external business partners, • Demonstrated leadership on cross-functional projects, • Demonstrated leadership in decision making and problem solving, • Excellent spoken and written English We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Required Skills: Preferred Skills: Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility #J-18808-Ljbffr