- 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
- Aequor (Newbury Park, CA)
- …Global Regulatory Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist US Regulatory ... regulatory history documents through systems and appropriately archive all regulatory documents and agency communications Review regional component of the… 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
- 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 and ... Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose creative, effective,… 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 ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member of… 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
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the ... process by applying the appropriate measures (writing of code, review of code/deliverable).Supports submissions by ensuring programming deliverables are consistent… more
- Merck & Co. (North Wales, PA)
- …our company's biopharmaceutical business.This position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & ... Job Description Position Description: Senior Specialist, Financial Planning & Analysis Our company's...analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… 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
- Merck & Co. (Rahway, NJ)
- …the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, ... Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's… more
- Merck & Co. (Rahway, NJ)
- …audits to investigate frequent field alerts, recalls, rejects and complaints.Support in informing Senior Management of emerging regulatory and PV trends to help ... aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety ... to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… more
- Merck & Co. (Rahway, NJ)
- …improving and protecting patient access to care. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the Executive Director, ... the Company's vaccines pipeline, including during late-stage development, distribution and regulatory milestones, in a manner that reflects the Company's purpose and… more
- Eisai, Inc (Louisville, KY)
- …is your profile, we want to hear from you. Job Summary The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting ... within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the oral… more
- Eisai, Inc (San Francisco, CA)
- …is your profile, we want to hear from you. Job Summary The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting ... within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the oral… more
- MEDSTAR HEALTH (Washington, DC)
- …Collaborates with the Director of Nursing in maintaining adherence to regulatory and accreditation standards, and MedStar Health's policies and procedures. ... with hospital/entity policies and procedures, clinical practice guidelines, and regulatory and accreditation standards.Develops and maintains effective relationships and… more
- Publicis Groupe (Philadelphia, PA)
- …www.digitashealth.com | Facebook: www.facebook.com/digitashealth| Twitter: www.twitter.com/digitas_health **Overview** The Senior Associate , Regulatory ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
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