- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... you to grow with us.As part of our Global Medical Writing team, you will drive the...the development of high-quality clinical documents to support operational, medical , and regulatory activities across the Genmab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...based upon academic training and job experience.Strong oral and writing skill. Able to write regulatory documents… more
- Merck & Co. (North Wales, PA)
- …ICH GCP Guidelines, Identifying Risks, Life Science, Medical Writing , Motivation Management, Prioritization, Project Management, Regulatory Compliance, ... specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... the programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical , Clinical… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... solving, prioritization, conflict resolution, and critical thinking skillsStrong communication, writing , and presentation skillsProficient knowledge in Microsoft office or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... review reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies.Lead… more
- Merck & Co. (North Wales, PA)
- …Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing , Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance, ... include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/ medical … more
- Merck & Co. (Rahway, NJ)
- …Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing , Motivation Management, Prioritization, Problem Solving, Regulatory Compliance, ... Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data/ medical … more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits ... Skills: Strong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and… more
- J&J Family of Companies (Spring House, PA)
- …by the Company. **We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to function ... manage a subset of TA). + If a people manager : + Manages a team of internal medical...is required. + At least 8 years of relevant clinical/ regulatory medical writing experience is… more
- Abbott (Maple Grove, MN)
- …diabetes from routine fingersticks. **The Opportunity** We are looking for our next ** Regulatory Operations Compliance Manager ** to join our team on-site out of ... Maple Grove, or St. Paul, MN locations. This Compliance Manager , Global Regulatory Operations would be structured... Regulatory Services managing projects related to harmonized regulatory activities in the Abbott's medical device… more
- Danaher Corporation (Vista, CA)
- …Learn about the Danaher Business System which makes everything possible. The Manager , Technical Writing & Training, Digital Pathology for Leica Biosystems ... curricula in Digital Pathology, partnering closely with R&D, Quality, Regulatory , commercial Service & Support, and other stakeholders to...of experience in a related field, such as technical writing or training, related to medical devices… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in Alameda, CA for our ... glucose levels with our new sensing technology. As the Regulatory Affairs Manager , you will combine your...and EN standards. + Communicate effectively verbally and in writing + Negotiate internally and externally with regulatory… more
- Abbott (Sylmar, CA)
- …responsibilities may include** (choose applicable areas and expand as appropriate); + Medical writing + Advertising and promotion + Labeling + Restricted ... Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our...medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and… more
- J&J Family of Companies (Spring House, PA)
- …pharmaceutical/scientific experience is required. + A minimum of 2 to 4 years of regulatory medical writing experience is required, depending on tasks ... + Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide. + Regularly meets with manager and mentors and attends… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market ... and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device...with BS/BA, or 7 years with MS preferred. + Regulatory affairs experience in writing US submissions… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work ... people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations** will provide… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...medical fields. + Advanced degree + 8 years' Regulatory experience + Experience working in a broader enterprise/cross-division… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical … more
