10 Pharmaceutical jobs

Job Description Overview The Delivery Driver for Reliance Rx Specialty Pharmacy will be part of an exciting and growth-oriented team.  The Delivery Driver will be responsible for coordinating and delivering products to patient homes and provider offices within a defined geographic area.  This associate will ensure that all deliveries are made in a professional, safe and efficient manner.   Coordination of deliveries to ensure organization and most effective delivery method is also required of this associate. Qualifications High School diploma or GED required. One (1) year experience driving for a delivery service with high-dollar and/or temperature sensitive cargo required. One (1) year of Pharmacy Technician experience preferred. Local travel required. Ability to operate a motor vehicle and maintain a valid driver’s license required. Any Reliance Rx associate who uses a motor vehicle in the course of their duties representing Reliance Rx must be compliant with New York State Motor Vehicle laws and must follow the Policy that pertains to Driver’s License Requirements as a condition of employment. Ability to provide excellent customer service through a high energy, professional approach is required. Works independently and exhibits ability to multitask and work with minimal supervision. Ability to communicate effectively with both patients and internal staff. Proven examples of displaying the Reliance Rx values: Collaborative, Accessible, Results-Oriented, Empowering and Supportive.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Prepare isolated adult animal cardiomyocytes for contractility assays Use pre-established experimental designs to plan, and execute myocyte contractility and Ca2+   transient assays Be responsible for data collection, organization and record keeping Identify, communicate and triage assay anomalies during data collection or analysis of experimental results Propose solutions to technical issues: proactively seek out senior team member to discuss potential resolutions to problems Collaborate with colleagues and team members to provide robust data Understand and follow IACUC approved protocols for animal use Flexibility to start (and leave) work early 2-3 times/week to initiate protracted experiments (~7:00 AM)   EDUCATION/EXPERIENCE/SKILLS:  Education: Requires a BS in physiology, pharmacology, or related discipline.   Experience: Minimum of 1-2 years of animal handling experience in a pharmaceutical industry or academic research lab setting Experience in pharmaceutical science, preferably in pharmaceutical industry focusing on cardiovascular science. Familiarity with cellular electrophysiology advantageous, but non-essential Technical Skills: Hands-on experience with animal handling (mice and rats), and tissue collection, particularly heart. Ex vivo adult rat cardiac myocyte isolation and myocyte contractility experience a plus  

Essential Responsibilities Develop a comprehensive understanding of the market environment, including market penetration, market potential, and future trends Manage primary & secondary market research studies, including project objectives & design, vendor selection & oversight, monitoring of data collection & analysis, and interpretation, across multiple customer groups Integrate key market dynamics and cross-functional expertise into revenue forecasts Build, refine, pressure-test, and present revenue forecasts that support decision-making processes for key cross-functional partners Develop relevant and compelling presentations of market research insights, revenue forecasts, and recommendations that drive key strategic and tactical decisions for cross-functional partners Manage ongoing business relationships with vendors, consultants and selected partners; manage complex projects within budget and timeline   Knowledge & Skills Experience designing and conducting quantitative and qualitative market research across multiple customer groups, including but not limited to physicians, patients, allied health care professionals, pharmacists, and advocacy groups Experience in building & maintaining forecast models as well as a firm grasp of complex forecasting & modeling techniques that support various types of strategic analytics; experience in generating commercial insights from pharmaceutical datasets Strategic thinker who understands the critical role of market research & forecasting in developing commercial strategy in support of a product launch; ability to operate in ambiguous situations and determine focused objectives and a clear path forward in the face of open questions Balance of exceptional technical expertise with strong strategic thinking and practical business orientation; strength in finding and focusing on key business drivers Ability to analyze complex issues, distill information to essential knowledge, develop business-relevant strategic recommendations, and persuasively present to a range of stakeholders Highly developed interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of backgrounds Ability to multiple manage projects and timelines for both internal initiatives and with external vendors Must have a proven ability to sustain a high energy level over time   Education & Experience BA, BS required. Master’s degree in business or science preferred 3 to 7 years of market research/forecasting experience in the bio/pharmaceutical industry Launch experience is preferred Previous consulting & recent bio/pharma experience is preferred  

Summary: This person reports to the Director of Technical Operations and Clinical Supply Chain. This role will allow the ideal person to be exposed to new methodologies.  Essential Functions These may include, but are not limited to, the following; other duties may be assigned: Develop clinical study supply plans and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company’s internal procedures and GxP requirements. Have experience and knowledge of executing Phase I – III protocols. Prepare clinical trial material forecasts at the study level and track material inventory, update use and expiry dating to ensure uninterrupted delivery of clinical study supplies. Proactively highlights to management when action is indicated.  “Actions” may include a shelf life extension or resupply submission to health authorities are necessary. Have experience and thorough understanding of IXRS/IRT systems and trial execution using these systems. Participate in global clinical drug supply activities associated with the team’s trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies) Vendor Management – Prioritize labelling and packaging activities at CROs/CMOs, when packaging operations for clinical trial material are in-process. Establish the packaging design based on protocol and manage all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors Ability to coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites Ability to coordinate courier deliveries and shipments, and manage the courier relationship.  Oversee packaging of materials according to IATA or DOT dangerous goods regulations. Oversee special projects including international shipments with awareness of required US Government certificate / license, if applicable, for worldwide shipment of investigational clinical trial material, drug substance, and drug product. Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives. Participates on clinical sub-teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies. Qualifications BS or Master’s Degree in life science, or related field (or equivalent experience) 8-10 years’ experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization. Preferably Certificate in Supply Chain Management Program Ability to work independently to make strategic decisions related to planning, and budgeting. Understanding of cGMP’s and pharmaceutical industry procedures and regulations Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience Hand on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software Strong, open and transparent communication skills (verbal and written) Solid organizational and time management skills Project management skills and computer proficiency Experience with: MS Excel, Word Ability and willingness to travel 10% of the time (internationally and domestically)

Position Summary: The Manager of SEC Reporting and Technical Accounting is responsible for all SEC financial reporting activities and technical accounting analysis. This individual will frequently interact with accounting staff, IT, legal, and other stakeholders across the organization as well as external SOX consultants and external auditors. This role requires critical thinking skills, effective organizational skills, excellent written and verbal communication skills, and a strong ability to build effective relationships across the Company. This position offers the successful applicant the opportunity to  leverage a strong background in external reporting, technical accounting and Sarbanes-Oxley compliance with the dynamics of a growing biotechnology company.  Responsibilities: Lead the timely and accurate preparation of Company’s SEC filings, including 10-Qs and 10-Ks, ensuring appropriate XBRL tagging of related content in Active Disclosure. Gather supporting data, tie outs and preparing information for review. Create and maintain SEC calendar, coordinate key timelines as well as deliverables and inform parties of necessary deadline adherence for the following processes: financial close, BOD package, press release and 10-Q/K Ensure financial statements are presented in accordance with GAAP guidelines. Proactively identify accounting & disclosure issues and perform related research and documentation of such issues in accounting whitepapers; propose suitable disclosures and benchmark against industry standards. Maintain relationship and work closely with External Auditors, Business Owners and Senior Management to ensure communication of critical issues in a timely manner. Coordinate/monitor/review the execution of audit procedures related to financial reporting and technical accounting topics. Partner with SOX consultants in documentation of SOX Risk Assessment, Risk Matrix, Process Documents, Testing Protocol, and Review Testing for financial reporting and other related cycles. Support the assessment of internal controls over financial reporting in according with the COSO Framework and Sarbanes-Oxley Act (SOX). Stay abreast of new accounting principles, SEC reporting and general trends. Participate in special projects and perform additional duties as required. Education and Professional Qualifications: Deep subject matter expertise in SEC reporting, technical accounting and US GAAP accounting standards CPA required, with a Masters in Accounting or MBA preferred Minimum of 6 years of relevant work experience to include 4 years for a Big 4 public accounting firm, followed by experience in SEC reporting for a publicly held, 404(b) compliant, large accelerated filer. Experience in preparing SEC financial filings for a public company, including use of an SEC filing platform, such as Active Disclosure Exceptional leadership and teamwork capabilities Excellent oral and written communications skills Strong personal drive for excellence and highly self-motivated with strong work ethics Well-developed problem-solving skills combined with experience working with outside consultants in a positive and collaborative manner. Enjoys being ‘hands-on’ and taking ownership of processes Able to work in an environment where sharing responsibility for success and mitigating the shortcomings of others on the team is critical to the overall success of the Company. Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings. Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions. Role model for MyoKardia’s values.  

Senior  Clinical Trial Leade r  (Sr. CTL) SUMMARY:     The Senior Clinical Trial Leader  ( Sr.CTL )   a cts as a  senior  clinical trial lead on one or more clinical studies.  He/She  d evelops, manages and coordinates all clinical trial activities for their studies including managing Clinical Research Organizations ( CROs ) , vendors and internal team members. The Sr CTL d evelops and applies best practices in the development, initiation, planning, execution, control and closing of projects.   He/She  is a proficient communicator  and effective influencer  who builds and maintains strong relationships internally and externally.   All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.   ESSENT IAL DUTIES AND RESPONSIBILITIES: Lead more than one or highly complex, adaptive or pivotal studies Plan   and execute studies from feasibility to close out, accountable for all study budgets, documents , drug supply, and plans with 3- year horizon Select countries and sites based on Clinical Development Plans and global Strategies Conduct program level feasibility and develop recruitment plans Actively lead  cross functional team  and  attend Clinical Sub Team/Project Team meetings as needed to represent Clinical Operations Create and maintain performance and quality metrics Contribute clinical information for Regulatory submissions and responses Proactively identify risks and devise mitigation plans Expert in complex vendors and relationships Select CRO, other vendors, manages  Scope of Work ( SOW ) , scope changes, budgets, approve all vendor payments .   Ensure that CRO has strategic direction for protocol(s) Hold  vendors accountable to  Scope of Work ( SOW ) Responsible for contributing to and delivering study and therapeutic area training for team and vendors Accountable for I nvestigator  M eeting s, oversee  planning Accountable for ensuring data quality and timely data reviews conducted May attend qualification or Site Initiation Visit Develops and drives site engagement strategy Highly skilled communicator, builds & maintains strong relationships internally and externally Drive protocol & amend ments Investigator Brochure, Informed Consent Form , monitor plans, risk management Reviews clinical sections of other regulatory documents e.g. annual or periodic safety reports, IND/NDA filings for quality and consistency Build  compelling, data driven case, clearly articulates vision to business partners, CROs,  etc Provides supervision, coaching and mentoring to new study leaders,  CTMs  and Associates Responsible for growth, development, and promotion of full time direct reports using development planning tools .  Contribute to hiring of new staff. Master of Clinical operations, can lead any study  and is a protocol expert Understand and apply  knowledge of science/biology, e.g. cardiology, mechanism of action of drug to planning and all phases of the study Seek  to stay current with new advances, competition Accountable for complete Trial Master File  and training of study team, internal and external business partners   Supervisory r equirements Directly supervises 1-3 employees May  be responsible for external consultants   EDUCATION/EXPERIENCE/SKILLS:   BS/BA required . MS/MA degree in related discipline desired . Typically requires a minimum of 8 years of related experience and/or combination of experience and education/training research in the biotechnology/pharmaceutical industry. Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities . Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management .     Knowledge/Skills/Abilities : Thorough clinical research knowledge and cross-functional understanding of clinical trial methodology is required. Knowledge of ICH-GCPs and 21 CFR is required . May lead or oversee the work of others by providing direction  and by  using established policies and precedents. General project management skills with the ability to organize, prioritize and manage numerous tasks and complete them under time constraints. Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques. Proficient with broad use computer applications such as MS Office and specialized applications as needed for job. Ability to travel up to 25%     JOB COMPLEXITY: Performs job duties with minimal guidance from supervisor . Works on problems of complex scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Creates formal networks involving coordination among groups.   VALUES: Patients first Passion for science Succeed together Imagine and innovate Lifelong learning  

Director, Clinical Statistics, Princeton, New Jersey   Job Location The position will be based in Princeton, N.J. with occasional travel to CHDI’s other offices in LA and NYC.   CHDI Foundation, Inc. CHDI is a private, not-for-profit research organization. We work with an international network of scientists to discover drugs that slow the progression of Huntington’s disease (HD). We seek to accelerate scientific progress by serving as a collaborative enabler. Our strategy is to encourage researchers to develop practical ideas, useful research materials, and powerful technologies, often by providing financial support. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials.   Director, Clinical Statistics This position will report to a Vice President/Unit Leader and will be responsible for coordinating internal and external statistical modeling projects in HD.   Job responsibilities Manage a portfolio of internal and external statistical modeling collaborations in support of CHDI’s clinical development efforts. Contribute to ongoing scientific dialog around the planning and execution of statistical and modeling efforts within the Foundation. Clean, manage and analyze data and communicate results as needed. Professional qualifications/skills The ideal candidate will   Have an advanced degree (Phd) in statistics, data science, biostatistics, epidemiology, public health, biomedical informatics, bioinformatics or related fields and a strong interest in healthcare or biological research. Demonstrate the ability to Creatively apply statistical and/or data mining techniques in the context of cross-sectional, longitudinal clinical study data. Techniques of interest include: regression, analysis of variance, mixed effects modeling, causal modeling, clustering, random forests, SVMs, text mining, etc. Apply experimental design concepts to the planning of data mining, observational and interventional studies Code and analyze data in a one or more standard programming/scripting languages (e.g. R, MATLAB, NONMEM, STATA, SAS, Python, Perl, Stan) Learn new statistical/data mining techniques and programming languages as needed. Interpret methodological results and convey them to a non-technical audience in an easy and effective manner. Manage and clean data. Personal skills :   Demonstrated skill in prioritization and time management. Demonstrated ability to organize, initiate and work independently to address responsibilities Team oriented with excellent interpersonal skills Excellent oral and written communication skills. Please send resumes to Alison.khan@chdifoundation.org  

Job Overview: This role is an exciting opportunity to be a part of our Pharmaceutical Staffing team of our Schaumburg, IL office; supporting the clinical research and development areas within the drug, device and biotech industries. Our Pharma division continues to rapidly grow and we are seeking experienced  Clinical Recruiters  to join us in our continuous strive for greatness.  We are looking for qualified candidates with a passion for establishing and building strong relationships and those who have a true interest in learning more about the industry, market trends, and candidates. We work as a team, we believe in striving for excellence, and we are passionate in our pursuit of the best talent in the industry. Named one of the fastest growing companies in the nation by Inc. Magazine, The Execu|Search Group offers each individual room for their own growth while also fostering a team environment. Below are a few reasons why you should consider an opportunity at Execu|Search!   On-going training as well as abundant career development resources for all employees We strive for a constant work-life balance for all employees Heavy emphasis on promotional and incentive opportunities We like to have fun with things like office ping pong tournaments, jeans days, Happy Hours, Summer Friday’s, and company sports teams, to charity runs/walks and firm-wide community initiatives, Execu|Search promotes teamwork and believes in rewarding hard work. Competitive Base Salaries and Uncapped Commissions We discourage bureaucracy and give each of our team members an opportunity to develop a voice at the firm Job responsibilities include, but are not limited to the following: Manage high volumes of job orders from mid-senior level searches -  both full-time and contract Create robust sourcing and recruitment strategies on a daily basis Build talent pipelines through networking, employee referrals, cold-calling and other creative channels –  exceptional sourcing skills Conduct in-depth talent phone screens, in-person interviews, and facilitate internal team discussions regarding candidates Communicate both client organizational information, job opportunity details, pre-close, negotiate and finalize offers Demonstrate commitment to being seen as a true ‘career advisor’ to both job seekers and clients We are looking for individuals with: 2 or more years of recruitment and/or staffing experience, in the areas of Clinical, Pharmaceutical, or Healthcare Staffing agency setting preferred Excellent communication and interpersonal skills, particularly in relationship building and follow up Ability to think strategically, execute effectively, and deliver high quality work against tight deadlines Strong motivation for personal success **This role is Base Salary + Uncapped Commission **

• Experience working to help develop or implement Acute Care products with primary focus on Pharmacy, Medication management and clinical modules  • Hands-on configuration experience with one or more Acute Care EHR applications is a must • Document requirements, workflows and processes (in the form of mock-ups, Visio diagrams, JIRA functional specification documents, test cases, and any other supporting documentation) for various scenarios/use cases for the Hospital. • An ideal candidate for this position has the ability to think critically, creatively, and abstractly; to synthesize differing points of view; to accept and incorporate feedback effectively • Demonstrate the latest product development, receive feedback, and propose solutions (in the form of mock-ups, diagrams, functional specifications, supporting documentation) to the Hospital Inpatient committee, Product Management/Development team.  • Promote a team atmosphere that is conducive to the overall accomplishment of goals, schedules, and deadlines. • Works on the clinical side and patient safety criteria to evaluate proper safety measures in the application • Drives resolution to end user issues. Works with all parties to prioritize issues and offer solutions. • Testing new modules/builds as needed during the early development cycle from the clinical expertise and report any potential patient safety  • Engages in multiple areas of the organization such as product management, clinical validation and product certification • Conduct trainings (as needed) for internal resources and customers. • Proven track record for implementing EHR in hospital from kick-off to go-live  • Expertise in integrating or working with Drug Databases such as MediSpan, FDB and Multum  • A detailed understanding of medical norms such as Rx Norms, PDMP, HCPCS, DCSCA • Ability to translate complex hospital workflow in simplified steps to help in development life cycle • Experience in configuring order sets by using evidence-based guidelines such as Zynx, ProVation • Experience in integrating 340b program for an organization  Requirements • Prefer location for this position is at our HQ in Westborough, MA but we’ll be flexible with one of our satellite offices or remote; if the candidate is the right fit. • For remote position; it will be required to be at our HQ for 12-16 weeks with onboarding process. • Required to be a certified Registered Pharmacist (RPh) with experience of 2+ years working in an acute care facility Ability to Travel to customer sites upwards of 20-30% • Must have prior experience working at a Hospital, pharmacy department with expertise in setting up formulary, maintaining pharmacy charge master, order entry (CPOE), verification • Must have prior experience in setting up and maintaining Pyxis, Aesynt or MedDispense cabinets • Ability to deal with stressful situations and have exceptional customer service skills/orientation • Basic knowledge of technical terminologies • To be able to coach and engage a diverse group of people • Exceptional communications (oral & written) skills • Must become an eCW Certified Professional • Ability to multi-task and excel in a fast-paced environment

As a Root Cause Analyst, you will conduct RCA investigations in order to determine the fundamental cause of the nonconformity that may extend beyond the immediate cause of a failure. You will work along with cross functional teams at eClinicalWorks to continue to deliver safe healthcare technology products to our customers. Responsibilities • Lead RCA investigations in order to determine the fundamental cause of the nonconformity that may extend beyond the immediate cause of a failure • Knowledge of and experience in conformance with ISO13485 and ISO14971/DCB0129 requirements • Identify and disposition of root cause of issues impacting patient safety and product quality • Performs data analysis necessary to determine the true root causes of a system, product or process nonconformity. • Meticulously record steps taken in the root cause investigation and record outcomes into an investigation tracking system. • Able to communicate technical information, and understand the organizational and regulatory expectations in conducting investigations (RCA/CAPA) • Work closely and follow through with Regulatory, R&D and Test, to ensure the highest quality products and processes are being developed and deployed as it relates to the root causes identified. • Build trend reports and communicate findings to team lead and upper management. • Interface within the CAPA database tool and cross functional department representation to manage CAPA workflow, coordinate CAPA meetings, acquire and report on CAPA KPI’s • Ensure on time processing and compliance to prevent reoccurrence of non-conformities. Requirements Requirements • Knowledge of and experience in conformance with medical device standards’ s requirements; ISO13485 and ISO14971/DCB0129; which are key for operationalizing CAPA and RCA • At least 2+ year of RCA work experience. Preferred • Master’s degree or equivalent. • Experience in regulated medical device industry • Prior experience with RCA and QMS Tools  Expectations • Perform other responsibilities as assigned. • This position is based in our Westborough, MA office. • May require occasional travel. • Willing to work additional hours as needed.