- 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
- 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
- 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
- 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
- NY CREATES (Albany, NY)
- …epicenter of high-tech innovation and commercialization. Job Description: JOB SUMMARY The Manager of Health and Safety is responsible for the management of the ... semi-conductor tools and support equipment with respect to site and applicable regulatory standards. Managing the review and comment on third party SEMI S2/S8/S14… more
- Planet Pharma (Princeton, NJ)
- …system validation principles and change control processes. *Ability to work collaboratively with Regulatory Affairs, Medical Writing , and other functions to ... Range: 37-47/hr *Depending on experience Job Category: Clinical Operations Job Title: Regulatory Publishing Manager I Duties The Manager /Sr. Manager , … more
- Eli Lilly and Company (Philadelphia, PA)
- …solutions to support communities through philanthropy and volunteerism. Position Overview: The Manager - CMC Regulatory is responsible for the preparation and ... delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. Responsibilities:… more
- Sunrise Senior Living (Metairie, LA)
- …COMMUNITY NAME Sunrise of Metairie Job ID 2025-225675 JOB OVERVIEW The Care Manager /"Designated Care Manager " is responsible for providing the highest degree of ... families in our assisted living/long term care and reminiscence neighborhoods. The Care Manager provides hands on care and physical and emotional support as outlined… more
- Eli Lilly and Company (Indianapolis, IN)
- …and scale-up/optimization for Ph3 and commercial launches. Responsibilities: The Sr. Manager of TS/MS Sterility Assurance is responsible for leading/mentoring a ... audit and inspection readiness and ensure timely closure of all regulatory commitments related to sterility assurance program execution. Provide support during… more
- IEC CORP GROUP (Garden Grove, CA)
- …an effective compliance plan. The position reports to the Regional Director/ Manager , Regulatory Compliance. The Compliance Officer conducts the preparation ... of all campus outcomes relative to accreditation and state regulatory compliance, including accreditation readiness visits, placement confirmation and related… more
- ASCENSION DEPAUL SERVICES (New Orleans, LA)
- …a long tradition of health ministry. DCSNO is seeking a full-time Operations Manager II. Directs day to day operations of designated Clinic site(s) and special ... health clinics. Manages systems and relationships to ensure quality care, safety, regulatory compliance and patient satisfaction. Resolves any work flow issues, and… more
- The Bay Club Company (Corte Madera, CA)
- …questions to truly understand the core of a matter. GENERAL SUMMARY The Club Manager is an exempt position whose primary responsibility is the financial success of ... creation and/or development of staff, programs, services and facilities. The Club Manager provides leadership to the management team and all Associates to ensure… more
- Medtronic (Irvine, CA)
- …of relevant experience Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs This is not a remote position Nice To Have ... 4 years of experience in medical device regulatory affairs Excellent technical knowledge...of the team. Excellent written and oral communication, technical writing and editing skills. Excellent leadership, interpersonal and influencing… more
- Northwestern University (Chicago, IL)
- …May co-author scientific papers for presentation & publication & coordinates writing , submission & administration of grants. Ensures that all study activities ... pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with… more
