Medical and Regulatory - WW and US Medical Communications Manager
TechDigital Group
Medical and Regulatory - WW and US Medical Communications Manager Position Summary The primary responsibility for the WW/US Medical Communications Manager is the development and execution of a comprehensive, globally aligned strategic WW/US medical publications and content plans to support the effective communication of data and launch for safe and effective use of Client medicines. Develop and update WW/US medical content per clinical development program, publications, data presentations, congress activity, MI inquiry trends, globalcommunication platform, product safety reports and treatment landscape. Key Responsibilities Primary accountabilities of the Medical Communications Manager include: • Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance and Client policies and procedures, and are used to appropriately communicate with healthcare providers and customers involved in healthcare or evidence-based healthcare decisions • Lead development of medical communications and ensure timely journal submissions, publications, congress presentations, and deliver internal and external scientific content • Understands and complies with established good publication practices (GPP3, ICMJE, and Client processes) to execute the publication plan • Manages and prioritizes multiple projects, provides solutions to complex problems,and delivers complete and accurate information within deadlines • Assists with the communication of the Oncology strategy related to healthcare providers, payers, access influencers, and healthcare decision makers • Serve as a subject matter expert to Client internal audiences related to communication landscape, HCP preferences, publication and scientific content planning, data disclosure / dissemination, and represent Client scientific communications to external investigators, key authors and journal editors • Manages development of content deliverables, such as reactive materials for field medical and field HEOR use, including core slide decks, training materials, FAQs, and backgrounders to address specific unsolicited health care provider and payer requests for health economic or outcomes research (HEOR) information • Maintains awareness of current industry practices that pertain to Medical Communications and Access Scientific Content • Work with cross-functional teams on a worldwide level to ensure consistent messaging and communication of medical information and key messages • Support the global standardization of Medical content to streamline creation, distribution and curation of content while eliminating redundancies in resource utilization and deliverables • Ensure effective rollout and communication occurs, feedback loops are implemented, and continuous improvement opportunities are identified for content development • Develops, maintains and enhances a high level of knowledge in the respective therapeutic area(s) to provide high quality medical communication support • Manage vendor agency partnership to drive planning and execution of publication and content deliverables Qualifications & Experience •Required: o PharmD, MD, PhD or equivalent o Minimum of 3-4 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications o Ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams. o Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate and collaborate o Experience leading cross-functional, cross-cultural project teams, and collaborating across matrix, multiple markets and global geographies o Experience leading medical communications across all phases of drug development and commercialization o Ability to analyze and interpret trial data •Preferred: o Experience in solid tumor oncology o In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication o Understanding of clinical trial design and execution, statistical methods and clinical trial data reporting requirements o Working knowledge of Microsoft suite of applications, and familiar with publicationmanagement tool (DataVision) #J-18808-Ljbffr
- ...Position Title: Senior Manager/Project Manager, Global Field Medical Excellence, [insert TA]... ...Location: Princeton Pike, NJ US Summary At Client,... ...within the Scientific Communications and Engagement (SCE)... ...in disease-state area, regulatory policy, & guidance for Medical...RegulatoryRemote workHome office
$187.1k - $327.5k
...Scientific Communications Business Alignment Director Facility: Medical Affairs Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk... ...portfolio and performance management, resource coordination...RegulatoryLocal areaFlexible hours$157.25k - $185k
...Sr. Manager, Clinical Pharmacology & Pharmacometrics... ...other resources empower us to innovate and touch... ...Pharmacology related regulatory documents and draft relevant... ..., and verbal communication skills are essential.... ...addition to a full range of medical, financial, and/or...RegulatoryLocal area$261.12k - $391.68k
...Medical Director (Oncology)At Genmab, we are dedicated... ...would love to have you join us!The Role:We are looking... ..., medical review and communication of data, and medical input into regulatory documents and presentations... ...approved by the hiring manager.Responsibilities:Directing...RegulatoryFull timeWork at officeFlexible hours$256.79k - $311.16k
...purpose-driven culture inspires us to discover, develop, and... ...& Commercialization Communications in Corporate Affairs, is responsible... ...closely with commercial, medical, regulatory, legal, and development... ...strategy, reputational issues management, and risk mitigation...RegulatoryHourly payFull timeSummer workLocal areaRemote workWorldwideFlexible hours$265k - $285k
...scientific excellence, regulatory compliance, and... ...senior leader on the Medical Affairs leadership team... ...collaboration. Team Management & Development Lead,... ...ability to interpret and communicate clinical data. Operational... ..., Princeton, NJ, 08540, US #J-18808-Ljbffr...RegulatoryFull timeContract workTemporary work$145.6k - $279.4k
...The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy... ...Lead and manage the preparation, review,... ...biotechnology products, and/or medical devices. Represent Regulatory... ...development stages. Communication & Interpersonal Skills –...RegulatoryWork at officeVisa sponsorshipWork visaRelocation package$183.8k - $330.3k
...decisions and support regulatory submissions. Here’s... ...forms, data listings, medical coding and patient profiles... ..., support managing study sites to ensure... ...developed interpersonal and communication skills. Capability to... ...direct mentorship. Join us in shaping a world where...RegulatoryPermanent employmentWork at officeLocal areaWork from home- ...Freyr is a leading global Regulatory Solutions and Services... ...cosmetics, food, and medical devices industries.... ...Title: Regulatory Project Management Specialist Location... ...for major markets (US, EU, etc.)... ...environment Excellent communication and interpersonal skills...RegulatoryPermanent employmentFull timeWork at officeRemote workFlexible hours
$117.84k - $176.76k
...we would love to have you join us! The Role Work arrangement:... ...and is approved by the hiring manager. Responsibilities/tasks–includingbutnotlimitedto... ...in compliance withCDISC and regulatory submission requirements,... ...Health Benefits: Two medical plan options (including HDHP with...RegulatoryFull timeFixed term contractWork at office$323.85k - $381k
...other resources empower us to innovate and touch... ...: Assumes the medical leadership on clinical... ...studies as outlined by the manager. Builds and... ...clinical development, regulatory and statistical activities... ...complex information, and communicate clinical information in...Regulatory3 days per week$65 - $70 per hour
...A leading biopharma organization is looking for a Sr. Manager, US Medical based in Lawrence Township. This role involves supporting medical affairs strategy execution, managing advisory boards, and gathering medical insights. An advanced scientific degree (PharmD and/or...$302k - $369k
...revenues of over $ 5 billion US Dollars. Supported by... ..., execution, and management of clinical trials to... ...for interactions with regulatory authorities and data monitoring... .... Collaborate with Medical Affairs and Commercial... ...written and verbal communications and interpersonal...RegulatoryContract workFlexible hours- ...Tris Pharma, Inc. in Monmouth Junction, NJ, is hiring a Manager, Medical Communications to support Medical Affairs with scientific content planning and delivery. The role partners with R&D and Commercial teams and external vendors to ensure accurate, balanced product information...
$131.04k - $196.56k
...would love to have you join us! The Role The Senior Manager, Clinical Programming... ...with CDISC and regulatory submission requirements,... ...Strong verbal and written communication skills; independent and... ...~ Health Benefits: Two medical plan options (including...RegulatoryFull timeFixed term contract$153k - $267k
...About The Department The Communications Department brings the value... ...employees and society in the US. Communications is comprised... ..., Media Relations & Issues Management is accountable for... ...Investor Relations, Clinical, Medical and Regulatory, plus other cross functional...RegulatoryWork at officeLocal areaFlexible hoursNight shift$145.6k - $279.4k
...and personally. Join us, the future is ours to... ...Description Leads and manages the preparation, review, and submission of regulatory applications, including... ...biotechnology products, and/or medical devices. Represents... ...of key milestones. Communication & Interpersonal Skills...RegulatoryWork at officeRemote workRelocation packageFlexible hours$119.7k - $149.6k
...Industrial Quality & Research, Medical Technology, Consumer... ...over 4,000 in the US and Canada alone! Make... ...a hands‑on Quality Manager to help support and scale... ...‑functionally with Regulatory Affairs, Supplier Quality... ...timely documentation, communication, and follow‑up for...RegulatoryLocal area$306.1k - $382.6k
...provide scientific and medical leadership across... ...study execution, and regulatory interactions. You will... ...development through lifecycle management while helping address... ...of study conduct Communicate appropriate program issues... ...USD What we offer US-based Employees: ~...RegulatoryWork at officeLocal areaRemote workNight shift3 days per week- ...join UroGen Pharma. Join us and be part of the team that... ...and partner with the Sr. Medical Director and other key stakeholders... ...Clinical Development, Regulatory Affairs, Data Management, Biostatistics,... ...and time zones. Excellent communication, presentation, negotiation...Regulatory
$238k - $280k
...other resources empower us to innovate and touch... ...the responsible medical monitor or a Lead medical... ...Clinical Research Scientist Manager to contribute to CRS... ...clinical content of regulatory submissions/documents... ...complex information, and communicate clinical information...RegulatoryInterim roleLocal area$142.6k - $178.3k
...Marketing, the Senior Manager, HCP Marketing – Health... ...with Sales, Medical Affairs, Market Access... ...Analytics (CIP/COBO), Legal, Regulatory, and Compliance to ensure... ...collaboration, communication, and influencing skills... ...300 USD What we offer US‑based Employees: Competitive...RegulatoryWork at officeLocal area3 days per week- ...Executive Medical Director, Clinical Development About Us Kardigan is a heart health company... ...— not in people management or program administration... ...processing and expedited regulatory reporting.... ...readiness. Scientific Communication Author and review abstracts...RegulatoryContract workFor contractorsInterim role
$306.1k - $382.6k
...strong network within the medical community, and... ...quality of study conduct.Communicate appropriate program issues... ...stakeholders.Support regulatory interactions,... ...subsequently to life cycle management.Review business development... ...,400 USDWhat we offer US-based Employees:...RegulatoryWork at officeLocal areaRemote workNight shift$239.08k - $289.71k
...with this job**Working with Us** Challenging. Meaningful.... ...partnering with Development, Medical, Regulatory, CMC, Commercial, and... ...recommendations to Executive Management.The leader must operate effectively... ...strategic direction, communicating with executive presence, and...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hoursShift work$174k - $204k
...Director, Clinical Supply Management Princeton, NJ (US) and Palo Alto, CA (US) About... ...resolving serious unmet medical needs. At Summit, we... ...presently approved by any regulatory authority other than China... ...authority and escal… Confident communicator able to influence all levels...RegulatoryContract workFor contractorsWork at office$125k - $155k
...Scientific Director, Medical Communications Remote, United States Are you passionate... ...and best practices. Ensure regulatory and compliance standards... ..., burn, and scope management. Scientific Leadership & Team... ...country. Please also notify us at ****@*****.***...RegulatoryLocal areaRemote work$150k - $258.75k
...healthcare innovation empowers us to build aworld where... ...merit. Job Function: Communications & Corporate/External... ...The Director will also manage one direct report: Senior... ...Government Affairs, Commercial, Medical Affairs, Human Resources, Legal, Regulatory, Investor Relations and...RegulatoryWork at officeLocal areaImmediate startFlexible hours$160.4k - $240.6k
...would love to have you join us!The RoleThe Associate Director... ...leadership for data programming, data management, and quality-control... ...based on the intended use and regulatory importance of the analysis.·... ...contributionsHealth Benefits: Two medical plan options (including HDHP...RegulatoryFull timeWork at office- ...Clinical Regulatory Affairs ManagerAn innovative technology company... ...Clinical Regulatory Affairs Manager to support regulatory strategy... ...to help bring cutting-edge medical technologies to market while... ...-based medical devices and communicate business impacts.Support interactions...RegulatoryFlexible hours
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