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Allucent is a full-Service contract research and developmentorganization with international resources dedicated to helpingpharmaceutical and biotechnology companies efficiently andexpeditiously navigate the regulatory approval process in order tobring new drugs, biologics, and medical devices to the people who needthem. Allucent is a non-Laboratory environment. At allucent, ourmission is to help bring new therapies to light. When you work atallucent, that means rolling up your sleeves and applying yourscientific knowledge, clinical expertise, and experience topartnerships with our clients in small and mid-Sized biotechcompanies. These customers have new therapeutic ideas but want apartner who can assist with the clinical trial process, thecomplexities of certain disease states, or other critical work with them on the newest treatment breakthroughs for someof the most perplexing conditions. And ultimately, youll help make apositive difference in patients lives. Location: remote europe thedirector clinical strategy is responsible for assisting clients withclinical strategy related development activities of drug, biologic ormedical device products. The director clinical strategy leads,develops and coordinates the activities of the clinical strategy teamensures timely preparation of organized and scientifically validquality deliverables translates regulatory requirements intopractical, workable plans and may lead or participate in healthauthority (ha) interactions as subject matter expert. Responsibilitiesmay include provision of strategy, review and authoring ofclinical/scientific documents. The director clinical strategy isknowledgeable in overall drug development process. The directorclinical strategy will serve on project teams in various capacitiesincluding, but not limited to: subject matter expert, technical lead,assistant consulting project lead, and consulting project lead. Thedirector clinical strategy may have one or more direct reports. Keyresponsibilities reviews and/or writes clinical/scientific documentsor sections thereof, with efficiency, accuracy, and independentthought has advanced knowledge of ha regulatory guidance & regulationspertaining to clinical strategy through all phases of drug or devicedevelopment and lifecycle management reviews and prepares ha questionsand briefing documents. Attends / may lead ha meetings as clinicalstrategy sme provides strategic advice and expertise in translatingclinical requirements into practical plans and solutions has advancedknowledge of ctd format and structure for regulatory submissionscontributes to due diligence reviews / reports learns and keepsabreast of updates to regulatory guidance, law, and best practicerelated to job functionality mentors less experienced clinicalstrategy scientists participates in interdepartmental communicationsto assist with compliance with regulations. Takes accountability forresponsibilities in area of expertise performs other scientist relatedduties as assigned director with and without direct reports: activelysupports staff learning & development within the company providesguidance and advises project leads, and/or project teams adherence toproject budgets and contracts including scope and scope changes,timeline deliverables and active management of resources managesprojects as a technical lead as assigned leads and/or participates inmeetings with clients provides mentorship to team members actsprofessionally with peers and clients, knows business etiquettedirector with direct reports: provides training to direct reports oncurrent and new regulatory requirements develops and presents internaland sponsor training actively manages direct reports includingdevelopment and performance management tracks line report utilizationand capacity coaches, mentors, and develops reports on collaborativeconsulting applies company policies and procedures to resolve avariety of issues identifies and mitigates risk assures goodcommunication and relationships with clients assists in the evaluationof potential technologies reviews business development proposals,project cost structures and participates in bid defenses monitors andevaluates industry trends to leverage service offerings to ensurebusiness growth (new opportunities and expansion of current clientbusiness) actively manages, develops, and strengthens clientrelationships, drives repeat business contributes to and participatesin client evaluations requires a ph.D., or equivalentdegree, in a scientific area, and equivalent combination of relevantexperience in drug, biologic, or device development advancedscientific and regulatory knowledge of drug, biologic, or devicedevelopment critical thinking and analytical skills, as well as strongwritten and verbal communication skills in english strong computerskills, including, word, excel, and powerpoint quality focus strongemotional intelligence, customer focused leadership anddecision-Making skills innovative, creative, and practical thinkingincluding problem-Solving skills 8 years experience with regulatoryrequirements of us fda, health canada and/ or european authoritiescomprehensive benefits package competitive salaries per locationfinancially rewarding talent acquisition sourcing bonus programdepartmental study/training budget for furthering professionaldevelopment flexible working hours (within reason) opportunity forhybrid/remote working (depending on location) internal growthopportunities and career progression opportunity to support globalrecruitment efforts access to online soft-Skills and technicaltraining via goodhabitz and internal platforms to all recruitmentagencies: allucent does not accept agency resumes. Please do notforward resumes to our careers alias or other allucent is not responsible for any fees related to unsolicitedresumes li-Mh1 similar jobs director, clinical strategy.
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