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Director Global Regulatory Affairs Lead - Oncology

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Rahway, NJ

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u003Cbu003ERequisition ID: u003C/bu003EREG003375u003Cbr/u003Eu003Cbr/u003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) face=Arialu003Eu003CFONT size=2u003EMerck u0026amp; Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itsu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Elegacy for over a centuryu003C/FONTu003Eu003CFONT size=2u003E. Mercku2019s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.u003C/FONTu003Eu003C/FONTu003Eu003C/Pu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CSPAN style=BACKGROUND-COLOR: rgb(255,255,255)\u003Eu003CFONT size=2 face=Arialu003Eu003CBRu003Eu003C/FONTu003Eu003CFONT size=2 face=Arialu003EMerck is on a quest for cures and is committed to being the worldu2019s premier, most research-intensive biopharmaceutical company. Today, weu2019re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Mercku2019s leading discovery capabilities and world-class small molecule and biologics Ru0026amp;D expertise to create breakthrough science that radically changes the way we approach serious diseases.u0026nbsp;u003C/FONTu003Eu003C/SPANu003Eu003C/Pu003Eu003CP style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu003CBRu003Eu003C/FONTu003Eu003C/Pu003Eu003CDIVu003Eu003CDIV align=justifyu003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) face=Arialu003Eu003CFONT size=2u003EThe Principal Scientist, is responsible for development and implementation of worldwide regulatory strategy for theiru0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Eassigned projects in the Oncology, Immunology and Devices therapeutic area. The individual functions with a high degreeu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Eof independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortestu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Etime to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, globalu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Epoint of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiariesu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Ewith regard to global regulatory strategy/registration requirements for one or moreu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003EMerck investigational and marketed drugs/Biologics. Programs may be complex with more than one indication, formulationu0026nbsp;u003C/FONTu003Eu003CFONT size=2u003Eor have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatoryu003C/FONTu003Eu003C/FONTu003Eu003C/DIVu003Eu003CFONT size=2 face=Arialu003Eu003CDIV style=BACKGROUND-COLOR: rgb(255,255,255) align=justifyu003Eagencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approvalu0026nbsp;for all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Productu0026nbsp;Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinicalu0026nbsp;Safety (GRACS) and external to GRACS.u0026nbsp;u003C/DIVu003Eu003C/FONTu003Eu003C/DIVu003Eu003CDIV align=justifyu003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu003CBRu003Eu003C/FONTu003Eu003C/DIVu003Eu003CDIVu003Eu003CDIV align=justifyu003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EPrimary activities include, but are not limited to:u003C/FONTu003Eu003C/DIVu003Eu003CULu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EReports to Therapeutic Area Leadu003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EDevelops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EProvide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EProvide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EReview and provide final approval of local registration study protocols when needed to obtain marketing authorization inu003CBRu003Esecondary markets.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003ERepresents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare Merck teams for meetings with FDA at any phase of drugu0026nbsp;development.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003ELead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003ECoordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EReview and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from Merck to external agencies and investigators.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003ERepresent GRA within internal Merck committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Developmentu0026nbsp;Team (EDT), and LEAD.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EConducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.u003C/FONTu003Eu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EParticipate in regulatory due diligence activities for licensing candidate review.u003C/FONTu003Eu003C/LIu003Eu003C/ULu003Eu003C/DIVu003Eu003Cbu003EQualificationsu003C/bu003Eu003Cbr/u003Eu003Cbr/u003Eu003CDIVu003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face='Arial'\u003Eu003CDIV align=justifyu003EEducation:u003C/DIVu003Eu003CDIVu003Eu003CULu003Eu003CLI style=TEXT-ALIGN: justify\u003EB.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinicalu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003Eexperience or regulatory affairsu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003EM.S. with minimum of 10 years drug development or clinical experience or regulatory affairsu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003EM.D. with minimum of 5 years regulatory experienceu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003EPhD with minimum of 7 years relevant regulatory experienceu003C/LIu003Eu003C/ULu003Eu003C/DIVu003Eu003CDIV align=justifyu003ERequired:u003C/DIVu003Eu003CDIVu003Eu003CULu003Eu003CLI style=TEXT-ALIGN: justify\u003EAbility to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.u003C/LIu003Eu003C/ULu003Eu003C/DIVu003Eu003CDIV align=justifyu003Eu003CBRu003Eu003C/DIVu003Eu003CDIV align=justifyu003EPreferred:u003C/DIVu003Eu003CDIVu003Eu003CULu003Eu003CLI style=TEXT-ALIGN: justify\u003EOncology experienceu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003EImmunology and biologics experienceu003C/LIu003Eu003CLI style=TEXT-ALIGN: justify\u003ESubstantial experience in regulatory affairs in one major country/region (eg. USA, EU).u003C/LIu003Eu003C/ULu003Eu003C/DIVu003Eu003C/FONTu003Eu003C/DIVu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and weu2019re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weu2019re inventing for life.u0026nbsp;u003C?xml:namespace prefix = o /u003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EIf you need an accommodation for the application process please email us at ****3Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu003CBu003ESearch Firm Representatives Please Read Carefully:u0026nbsp;u003C/Bu003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EMerck u0026amp; Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.u0026nbsp; Please, no phone calls or emails.u0026nbsp; All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.u0026nbsp; No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.u003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003EFor more information about personal rights under Equal Employment Opportunity, visit:u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u003CA href=****target=_blanku003Eu003CFONT color=blueu003EEEOC Posteru003C/FONTu003Eu003C/Au003Eu003Co:pu003Eu003C/o:pu003Eu003C/FONTu003Eu003C/Pu003Eu003CP class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003CFONT style=BACKGROUND-COLOR: rgb(255,255,255) size=2 face=Arialu003Eu0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u003CA href=****target=_blanku003Eu003CFONT color=blueu003EEEOC GINA Supplementu0026nbsp;u003C/FONTu003Eu003C/Au003Eu003C/FONTu003Eu003C/Pu003Eu003Cbr/u003Eu003Cbr/u003Eu003Cbu003EJob: u003C/bu003ERegulatory Affairs Liaisonu003Cbr/u003Eu003Cbu003EOther Locations: u003C/bu003EUpper Gwynedd, PA, US u003Cbr/u003Eu003Cbu003EEmployee Status: u003C/bu003ERegularu003Cbr/u003Eu003Cbu003ETravel: u003C/bu003EYes, 15 % of the Timeu003Cbr/u003Eu003Cbu003ENumber of Openings: u003C/bu003E1u003Cbr/u003Eu003Cbu003EShift (if applicable): u003C/bu003Eu003Cbr/u003Eu003Cbu003EHazardous Materials: u003C/bu003Eu003Cbr/u003Eu003Cbu003ECompany Trade Name: u003C/bu003EMerck,datePosted:2018-08-10,employmentType:FULL_TIME,industry:null,hiringOrganization:{@type:Organization,name:Merck USA},identifier:{@type:PropertyValue,name:Merck USA,value:REG003375-en_US},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Rahway,addressRegion:NJ,postalCode:07065}}}

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