- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review ... Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose creative, effective,… more
- Aequor (Thousand Oaks, CA)
- Regulatory Affairs Associate - CW Remote EST preferred. Ideal candidate: BS &plus 4YOE or MS and around 2 YOE. Preferred or pharma experience. Veeva PromoMats ... pivot tables) and author/update MSWord documents. Experience in labeling and Regulatory document management. Experience in promotional review and approval… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Aequor (Newbury Park, CA)
- …Global Regulatory Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist US Regulatory Lead ... regulatory history documents through systems and appropriately archive all regulatory documents and agency communications Review regional component of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Review and interpret regulatory guidelinesContinuing ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review … more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.RolePerform safety review of Adverse Event reports for Genmab products. Perform ongoing surveillance ... departments and ensure appropriate and timely handling of safety issues. Provide safety review and input to various documents including but not limited to: Trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA… more
- Merck & Co. (Rahway, NJ)
- …aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job ... contactors, and external business partnersPerform and Support PV audits as required. Review and Approve Corrective and Preventive Actions (CAPA)s which are necessary… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of ... trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication… more
- Merck & Co. (North Wales, PA)
- …investigators.-Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Associate Director, Digital Content Strategy & Production reports to the Dir, Content & Channel ... Social Media Marketing and related recommendations for the NNI US website. The Associate Director supports the development and evolution of NNI's content strategy in… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in ... study start up (eg, database set up) Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible for managing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Merck & Co. (North Wales, PA)
- …marketing opportunities.Proficiency in a highly regulated environment (with medical/legal review processes), including bring materials through legal, regulatory ... Job DescriptionJob Description:The Associate Director, Marketing, HPV Scientific Strategy plays a critical role in supporting the HPV vaccine franchise.- The HPV… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
