100 Pharmaceutical jobs

The Reliability Maintenance Technician is responsible for authentication of equipment database including reconciliation of field tagged UID's, proper execution of change control, technical support of craftsmen, drawing reconciliation, review and development of risk classification and area specific assignments.  TheRMT will provide data entry for all data changes and additionsfromallapprovedRFPMs including, but not limited to: Existing equipment updates  Equipment Hierarchy and associated equipment nameplate data Equipment Classification and Categorization Equipment Criticality PM Schedule information (Frequency, due dates, etc.) Job Plan information (Task / Material Lists) New equipment entries from Capital or expense projects from approved Data Entry Spreadsheet Equipment updates based on Validation activities (Interface with Project and Maintenance Validation Engineers) PM / CAL Development and Optimization activities Data updates based on Data Integrity Report findings  

HKA is seeking an experienced Quality Assurance Manager to oversee QA and Compliance at our clients’ pharmaceutical manufacturing location in Kalamazoo, MI. This is an exciting opportunity to join one of the best worldwide companies with endless options and opportunities for career growth! If you are searching for a new opportunity in the Life Sciences environment, then look no further. We are looking for your expertise in ISO-based Quality Management Systems, internal and external auditing, CAPA management, as well as metrics tracking to help ensure compliance within the pharmaceutical manufacturing environment. This is a client-facing position. Accountabilities: To provide guidance as the Quality Assurance SME at the client site. To lead compliance assessments of GxP and non-GxP related services while adhering to schedules, deadlines, and milestones. These services may include: Distribution logistics GMP cleaning Pest control Instrumentation services Records services Technical lab services 3rd party contract management Waste disposal Functioning as the lead investigator to analyze root-causes and determine proper implementation path(s) for corrective actions when GxP deficiencies are discovered. Manage and develop the quality program at the site as well has have significant impact upon the portfolio level quality program. Present quality related topics to local client management and site and corporate leadership. Maintain communication with key client personnel. Provide guidance and assistance to Quality and Compliance staff. Conduct training in GxP and QMS topics, to the wider operations team. Function as a leader, or as an SME for various processes (including change control, risk management, GxP related training, 3rd party vendor management, etc.) in support of compliance to relevant standards.

Work hours are 6am to 6pm on Tue, Wed, Thu and 2pm to 6pm on Fri.  The Security Guard will check-in contractors, emphasize PPE requirements. Compile a list of contractor hours worked monthly and submit it to safety personnel. Verify truck driver employment – Drivers must have 2 forms of photo ID that are either carrier issued, or agency issued. Inform truck drivers of safety rules, emphasizing PPE and speed limit requirements. Sign in all plant visitors, provide visitors with visitor pamphlet and issue them visitor passes. Call visitors contact person and inform them of visitor’s arrival. Verify that visitors are not wearing contact lenses. Monitor plant security cameras. Lock and unlock railroad gates. Search incoming vehicles. Search employee bags and boxes when requested to do so by management personal. Maintain daily log highlighting any security events. Direct trucks to loading and unloading docks and racks. Verify load and order numbers from inbound and outbound truck drivers and inform plant supervision of arrival and departure. Weigh tank wagons and print scale ticket for inbound and outbound loads. Verify certificate of analysis with lab before accepting inbound raw materials. Run daily shipment schedule, allocate, process, and print paperwork for orders going out through the plants SAP system, print and distribute shipping paperwork as necessary. Verify hazmat documentation, proper placards, and driver signatures on all outbound loads.

Axiom Staffing Group is currently recruiting for a contract Recruiter for a pharmaceutical development company in the Atlanta, GA area. Job Description: Assist HR Manager with open positions Source candidates for laboratory, administrative, and management positions Conduct phone screens, interviews, reference checks Complete the on-boarding process for each new hire Document applicant process in ATS ASG101

Title: Strategic Development Director Oncology Location: Ventura County, CA Industry: Pharma/Biotech Job Category: Design & Innovation within Global Clinical Development Contact: Ken Kupersmith kkupersmith@smithhanley.com #GD Full-scale Biotechnology Company that integrates the nimble and innovative culture of a small biotech with the stability, heritage and experience of a pharmaceutical company. Advancing the largest early Oncology pipeline in its history spanning several innovative technology platforms - across many targets and more than a dozen tumor types. The Design and Innovation (D&I) group within the Global Clinical Development organization is excited to unite with the most passionate and brilliant clinical development talents who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world. The Strategic Development Director (SDD) within D&I works across our oncology pipeline to provide teams with expertise and leadership in the design of innovative clinical development programs and clinical trials. Embedding with product teams during clinical development planning, the SDD brings a holistic knowledge of the end to end clinical drug development process to promote innovative design options that address appropriate clinical questions. The SDD partners closely with the Directors of Statistical Innovation (DSI) to develop and promote the adoption of cutting-edge statistical approaches to program and study design to ensure the most efficient development of our oncology pipeline. Responsibilities: 1. Supports the development and delivery of the Evidence Generation Plan / Clinical Development Plan 2. Supports complex development decision making throughout product development cycle. The SDD leads teams through a qualitative approach to create strategic development options through framing, issue raising and classification, decision hierarchy, and strategy table generation 3. Identifies value measures, trade-offs, risks, and gaps in development strategy 4. Identifies opportunities to apply non-quantitative innovation (e.g., mobile technology, patient voice) to development programs 5. Brings the right functions together at the right time and integrates cross-functional input to facilitate end-to-end clinical development 6. Objective leader that influences the adoption of novel or innovative approaches 7. Liaises with operational design lead to support downstream protocol development and innovative trial execution Education and Experience: Doctorate degree and 4 years of Clinical development experience OR Master's degree and 8 years of Clinical development experience Preferred Qualifications: 1. 10 years of clinical research design experience in a clinical setting and in executing clinical trials 2. End-to-end product development knowledge and experience 3. Proven experience in innovative study design approaches such as adaptive design 4. Ability to integrate and synthesize cross-functional input as it relates to evidence generation and apply decision science framework to facilitate data-driven decision making 5. Understands how data and analytics can inform study design, development options, and knows where / when to apply them

Title: Commercial Analytics/Data Science Consultant-PHARMA Location: Boston, MA Salary: $110- 135K + bonus Contact: Eda Zullo, ezullo@smithhanley.com #GD My client, a boutique pharmaceutical consulting firm, is seeking an "Analytics Consultant-PHARMA" Professional! Job Summary: Translate business questions into an analytical framework, partner closely with stakeholders, manage and execute project successfully, publish milestones and results. Incumbent will manage projects and should possess excellent client management and project management skills. Responsibilities: -Manage projects in areas of Marketing Mix Modeling, Promotional Responsiveness (ROI), Segmentation/Targeting, Multi-Channel/Digital Marketing Effectiveness and Sales Forecasting -Understand and translate client requirements to offshore team in terms of clearly defined deliverables with timelines -Create insightful summary and deck (storyboarding) in order to provide strategic recommendations to clients and other stakeholders. -Maintain seamless communication with client, get necessary clarifications and resolve outstanding issues proactively. Visit client office three days a week. -Independently work on ad-hoc projects end-to-end with necessary support from off-shore team Requirements: - 5- 7 yrs. of experience in Marketing and Sales Analytics in the Pharma/Healthcare space. Prior experience of having client management and project management is mandatory. -MA- Engineering, Operations Research and/or Statistics from top university -Hands-on experience with Base SAS and SAS Macro, knowledge of R will be valued too. -Strong analytical aptitude and technical ability to explore and innovate -Must possess good interpersonal skills along with excellent presentation and communication skills -Proficient in Microsoft Excel & PowerPoint. Ability to work with visualization tools e.g. Tableau, Spotfire etc. will be considered good to have skill-set. -Ability to think out of the box, assess current processes and offer ideas for improvement.

Title- Sr. Manager, Strategy Insights & Planning -Patient Marketing-PHARMA Location -Southern NJ Salary- $140-155k + 15% bonus Consultant- Eda Zullo, ezullo@smithhanley.com #GD My client, a Global Pharma Consulting company , is seeking a "Senior Manager, Strategy Insights & Planning-Patient Marketing" Professional! In this role you will be responsible for- *Day to day delivery of work to client within the practice *Client management *supporting internal Initiatives to develop solutions for the group *Work with project leadership to define project scope and develop approach *Consumer and patient marketing channels, including innovative channels like digital, social, mobile, as well as traditional consumer and patient marketing channels including mass, in-office, targeted print, and integrated CRM programs to support the client needs Requirements MBA/ BA degree with a quantitative background- economics, decision sciences, mathematics * 5-8 years of pharma/biotech industry in an analytical role *Tactical planning experience across a range of therapeutic categories and patient needs, including experience in developing CRM (acquisition and retention) program strategy; *Ability to fully understand and be comfortable with analytics and research capabilities.

Title: Medical Science Liaison Oncology Location: Gulf Coast Territory (TN, LA, AL, MS, AR) Company: Top Biotech Company Compensation: $150K-$190K Base + Bonus + Big Stocks + Amazing Benefits Contact: Ken Kupersmith- kkupersmith@smithhanley.com ***Serious Inquiries Only: If you apply and do not meet the below requirements you will not be contacted or considered*** * Currently or Recently in a Medical Science Liaison (MSL) role in Oncology/ Hematology * At least 2 years in an MSL role * Doctorate required (PhD, PharmD, MD, etc.) * Live within the Guld Coast Territory of Tennessee, Louisiana, Alabama, Mississippi, or Arkansas Medical Science Liaison Oncology/Hematology The ideal candidate for this position will be responsible for the facilitation and development of relationships with, and communication of product-related information to Key Opinion Leaders and members of the scientific/medical community, including health care providers, research investigators, institutions, cooperative groups, consortia, managed care organizations, and P&T committees. The MSL role will also gather insights from the field into actionable items and will serve as a subject matter expert (SME) on Oncology related products and disease areas, providing information on developments in research and medical management for approved agents and compounds in the development pipeline. This position will report to the Director - Medical Science Liaisons (within US Medical Affairs). The geography for this MSL position includes: Tennessee, Louisiana, Alabama, Mississippi, and Arkansas Travel is required and will be approximately 60%. Email your resume to: kkupersmith@smithhanley.com

TITLE: MEDICAL DIRECTOR GMA IMMUNO-ONCOLOGY LOCATION: BOSTON, MA COMPANY: TOP BIOTECH COMPANY COMPENSATION: $170K-$250K BASE + BONUS + STOCKS + AMAZING BENEFITS CONTACT: KEN KUPERSMITH - KKUPERSMITH@SMITHHANLEY.COM The Global Medical Affairs (GMA) Medical Director will support immuno-oncology product activities related to PD-1 inhibition in the Global Oncology Franchise. Checkpoint inhibitors involving PD-1 have the potential to change the landscape for patients diagnosed with a spectrum of malignant diseases. The initial PD-1 registration strategy is planned for skin cancer with multiple other indications to follow. The role functions internally as a strategic expert in immuno-oncology to support the development and execution of an efficient and integrated global medical/scientific strategy, including scientific evidence generation and scientific information exchange with key stakeholders. Responsibilities: 1.Reviewing and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial. 2.Supporting successful launch in cutaneous oncology indications and preparing groundwork for future indications 3.Ensuring that Oncology PD-1 product data generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner. 4.Interacting with experts at medical meetings, advisory boards, internal stakeholders and outreach meetings to represent company and strengthen its reputation in Oncology. 5.Immuno-oncology treatment expertise Preferred Candidate Attributes: 1.Doctorate in relevant scientific discipline or pharmacy - MD preferred, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology ideal. 2.Experience in Medical Affairs is strongly preferred 3.Proven success in how to conceptualize, design, and conduct complex, global clinical trials 4.High energy and an absolute commitment to a culture that operates with high ethical standards 5.Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders. 6.4+ years of Pharma based Oncology Medical Affairs experience

Title: MEDICAL DIRECTOR RARE BLOOD DISORDERS Location: Boston, MA Company: Top BioPharma Company Compensation: $140,000 to $270,000 Base + Bonus + Stocks + Amazing Benefits Contact: Ken Kupersmith - KKUPERSMITH@SMITHHANLEY.COM Responsibilities: 1.Determine/refine the US Cold Agglutinin Disease (CAD) Medical Affairs strategy and create the vision of excellence in Medical Affairs for the future. 2.Serve as the internal expert for CAD and Cablivi and supports the field-based U.S. medical affairs team 3.Develops strategies for and implements national medical advisory boards 4.Execution of the strategic U.S. investigator-sponsored study program 5.Develops the CAD specific U.S. scientific communication and publication strategies 6.Develop systems, processes and standards to ensure the creation and effective operation of the new Medical Affairs function. 7.Support pricing and reimbursement efforts in alignment with Market Access lead. 8.Work closely and guide the Medial Review and Promotional Review Committees 9.Support the implementation of the Global Publication Plan, with key focus in driving the strategy and implementation in NA, ensuring an efficient and effective communication of the available Sutimlimab data. 10.Work closely with R&D and Commercial to support pre- and post-launch activities. 11.Develop and maintain relationships with a wide array of external stakeholders, including relevant advocacy groups, KOLs and advisory Board members and others in the clinical and scientific community, plus where appropriate, key decision makers in Payer organizations, etc. 12.Contribute to the clinical strategy, and execute all Phase IIIb and IV clinical programs and any other late-phase research activities (i.e., registries). Qualifications: 1.MD qualification preferred and a solid track record of achievement in Medical Affairs in the biotech/pharma industry. 2.Ideally have worked in the field of orphan diseases; Hematology experience would be advantageous. 3.Experience in clinical trial design, especially phase III-IV 4.Able to make complex science understandable for a non-scientific audience. 5.MD or MD PhD preferred 6.MBA would be a plus.

Smith Hanley Associates Principal Biostatistician Washington DC area Nihar Parikh, nparikh@smithhanley.com Our client a global biopharma, has an opening for a Principal Biostatistician to provide statistical expertise, clinical trial design, and analysis for clinical development programs. Provide modeling and statistical oversight and standards for study level work. Seeking candidates with experience in Oncology, Respiratory, Cardiovascular, or other disease areas. Responsibilities: -Oversee clinical development plans, SAP, and study design. -Support protocol development and provide strategic guidance for global project teams. -Lead regulatory submissions, provide regulatory strategy and interact with the FDA. -Support clinical study report writing and clinical publications as well as compound development across major therapeutic areas. -Apply statistical principles and provide solutions to problems in drug research. -Provide statistical oversight to vendors, mentor staff and work with cross-functional teams. Qualifications: -MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Pharma/Biotech as a study Statistician. -Background in therapeutic areas such as Oncology, Respiratory, Cardiovascular, etc. -Experience in regulatory submissions, clinical development and statistical analysis plans. -Experience in program design, clinical study reports, statistical protocol and regulatory interactions. -Experience in SAS/R programming. -Strong interpersonal and communication skills. Smith Hanley Associates is a niche recruiting agency. #GD www.smithhanley.com

Smith Hanley Associates Director/Senior Director, Statistical Programming Washington DC area Nihar Parikh - nparikh@smithhanley.com Exciting leadership opportunity to join a global biopharma and oversee a team with statistical programming, regulatory submissions, data standards, clinical drug development, and foster decision making. Serve as core member of the programming leadership team. Responsibilities: -Manage a therapeutic area and direct programming projects. -Oversee quality of deliverables and lead clinical development plans, regulatory submissions, and data collection. -Manage clinical development programming, analysis and reporting, as well as information infrastructure. -Implement best practices, develop strategies, and improve statistical methodologies within drug projects. -Duties include standards development and technical guidance to meet business objectives. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -Proven leader in the pharmaceutical or biotech field and experience in statistical programming within clinical drug development. -Strong knowledge of CDISC standards such as CDASH, SDTM, ADaM, etc. -Strong SAS expertise and a background in Oncology, Respiratory, Inflammation or similar therapeutic area. -Experience in NDA/BLA regulatory submissions and good clinical practice. -Strong technical knowledge and people management background. Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/ #GD

Smith Hanley Associates Senior/Principal Statistical Programmer Washington DC area Nihar Parikh - nparikh@smithhanley.com Our client, a global biopharma, has openings for experienced Statistical Programmers at the Senior or Principal level. In this role you will provide statistical programming support for drug products including analysis and reporting, clinical studies, regulatory submissions, commercialization, and technical standards. Responsibilities: -Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and more. -Deliver clinical study reports, SDTM/ADaM databases as well as tables, listings and figures results. -Provide statistical programming for regulatory submissions. -Manage technical database standards and programming specification documents. -Develop best practices and monitor safety/efficacy of the data. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -5+ years' experience in the pharmaceutical/biotech industry required. -Background in Oncology, Respiratory, Cardiovascular, or similar therapeutic area. -Experience in clinical drug development, regulatory requirements, CDISC standards, and submissions. -Experience in statistical programming, report publishing, and business processes. -Strong SAS programming; Exposure to R, SQL, etc. a plus. -Strong technical and project management skills as well as the ability to influence stakeholders. Smith Hanley Associates is a niche recruiting agency. #GD www.smithhanley.com

Smith Hanley Associates Associate Director, Biostatistics Gaithersburg, MD Nihar Parikh - nparikh@smithanley.com In this role you will provide leadership on statistical methodology, study design, clinical development plans, and strategic insights. Seeking candidates with experience in Oncology, Cardiovascular, or Disease therapeutic areas. Responsibilities: Lead the clinical development process, formulation strategy, and regulatory guidance within a therapeutic area. Provide statistical analysis and data interpretation for CSRs. Oversee Statistical Analysis Plans and regulatory submissions. Collaborate with cross-functional teams by driving statistical thinking, data analysis, and study protocol. Provide statistical guidance and mentor statisticians. Requirements: Advanced Degree in Biostatistics, Statistics, or similar field and 6-8 years of experience in the pharmaceutical industry. Experience with clinical study design, statistical methodology, and analysis. Experience in regulatory interactions and submissions. Knowledge of ICH/EMEA/FDA guidelines. Experience managing projects, mentoring statisticians, and effective team leadership skills. Smith Hanley Associates is a niche recruiting agency. #GD www.smithhanley.com

Smith Hanley Associates Associate Director/Director, Statistical Programming Washington DC area Nihar Parikh - nparikh@smithhanley.com Our client, a global biopharma, has leadership openings in statistical programming. In this role you will lead programming projects, clinical development plans, technical data standards, regulatory questions, delivery of databases and reporting. Responsibilities: -You will be the programming leader at the drug project level. Support the clinical development process, project strategy, regulatory submissions, commercialization of company drug products and information deliverables. -Provide technical expertise, delivery of SDTM and ADaM datasets, as well as quality of deliverables. -Oversee information infrastructure and quality improvements to the methodology. -Contribute to best practices for statistical programming globally. Qualifications: -Seeking candidates with a degree in Biostatistics, Applied Mathematics, Engineering, Life Sciences or related fields. -Extensive SAS programming and pharmaceutical experience required. -Experience in therapeutic areas such as Oncology, Diabetes or Diseases. -Experience in CDISC standards, regulatory submissions, and clinical drug development. -Advanced problem solving and ability to lead/mentor teams. Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/ #GD

Smith Hanley Associates Principal Biostatistician Boston, MA Nihar Parikh - nparikh@smithhanley.com This is an exciting opportunity to join a startup that is creating a new field of medicine to combat disorders. Seeking a Principal Biostatistician with an analytical mindset, clinical trial design, experience within an FDA pipeline as well as advanced statistics. Responsibilities: Design clinical trials, perform data analysis and strategic planning for multiple phases of the drug pipeline. Implement statistical methodologies, evaluate clinical outcomes and randomized trials. Perform product development and testing, hypothesis generation and clinical validation. Partner with CRO's and manage the clinical trial lifecycle including data management. Requirements: MS or PhD in Statistics, Biostatistics or related field. Experience with SAS, R, and other statistical programs. Seeking 5+ years of experience analyzing clinical trial data and strong statistical analysis. Experience working with CRO's, regulatory agencies and other external partners. Smith Hanley Associates is a niche recruiting agency. #GD www.smithhannley.com

Title- Engagement Manager-PHARMA Location- Central New Jersey Salary-$130-160k (DOE) Consultant- Eda Zullo, ezullo@smithhanley.com #GD My client, a boutique consulting firm, is seeking an "Engagement Manager/Project Manager-PHARMA" that will support our premier Pharma/Biotech clients. In this role you will translate business questions into an analytical framework, partner closely with stakeholders, manage and execute project successfully, publish milestones and results. You will manage projects and should possess excellent client management and project management skills. Responsibilities: *Manage projects in areas of Marketing Mix Modeling, Promotional Responsiveness (ROI), Segmentation/Targeting, Multi-Channel/Digital Marketing Effectiveness and Sales Forecasting *Understand and translate client requirements to offshore team in terms of clearly defined deliverables with timelines *Create summary and deck (storyboarding) that provides strategic recommendations to clients and other stakeholders. *Maintain communication with client, get necessary clarifications and resolve outstanding issues proactively. Requirements: *7 to 9 years of experience in Marketing and Sales Analytics. * Prior experience of having client management and project management is mandatory. *MA in Engineering, Operations Research and/or Statistics is desired *Strong knowledge SAS Base and SAS Macro, and R will be valued too. *Strong analytical aptitude and technical ability *Must possess good interpersonal skills along with excellent presentation and communication skills

Title: Sr. Oncology Sales Trainer #GD Location: San Francisco, CA Company: TOP Biotech Company Compensation: $200K Base + 20% Bonus + Stocks +Amazing Benefits Contact: Nancy Ragonese- nragonese@smithhanley.com; Tel. 203 319-4315 ***Serious Inquiries/Applicants only. If you do not meet the below requirements you will not be considered/contacted*** FANTASTIC Opportunity in ONCOLOGY SALES TRAINING with growth and impact at a TOP Biotech Company! - Must have at least 2 years experience in Training at a Pharma/Biotech/Med Device Company (Field Sales Trainers considered) - Oncology or Hematology background is a MUST - Must reside in the San Francisco area (can work remote 1-2 days per week) - Full relocation can also be provided to a superstar candidate! If you qualify please email your resume to me at: nragonese@smithhanley.com

Title- Sr. Manager, Commercial Ops/Analytics-PHARMA Location - Central NJ Salary- $130/140k + bonus Consultant- Eda Zullo- ezullo@smithhanley.com My client, a mid-size Pharmaceutical Company, is seeking a "senior Manager, Commercial Ops/ Analytics-PHARMA" Professional! Responsibilities *Will be the conduit to the business- providing analytics, forecasting, sales analytics *provide CRM data to the business *implement business requirements *manage internal and external resources to develop stat of the art programs for the business Requirements- *BA Degree / MAS desired * 5-7 years Pharma experience in Pharmaceutical Commercial analytics/Ops space * Data Mapping skills * Strong understanding of CRM technologies * Must be a able to have a vision and be a critical thinker * Knowledge of VEEVA, Tableau, Excel, etc.

Title- Senior Manager, Digital Analytics Influencer-PHARMA Location - NYC Salary- $140-170k + bonus Consultant- Eda Zullo, ezullo@smithhanley.com My client, a BIG GLOBAL PHARMA Company, is seeking a "Senior Manager, Digital Analytics Influence-PHARMA" Professional! Responsibilities- *Analytical Project Leadership-will lead the analytics projects by scoping, modeling and implementing the roadmap * Change Management - serve as the advocate for emerging customer analytic techniques *Collaboration with other Advanced Analytic Teams-Join together with other teams- Data Science, Resource Allocation for advancing the strategic priorities Requirements * STEM Degree, advanced degree desired *7 years Analytics/ 5+ years in the digital space *Strong statistical machine learning skills *Proven knowledge and experience with "Social Network Analysis" and "Network Influencing/analysis" *Experience with graph database desired