77 Pharmaceutical jobs

Job Description: 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.  The RMT will provide data entry for all data changes and additions from all approved RFPMs, 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

Support all warehousing activities including shipping product worldwide, receiving of incoming goods, dispensing packaging components to the Packaging Department, supporting the annual physical inventory, supporting the destruction process and any other inventory management activities in Malvern, PA.    Skills: Familiarity with GMP compliance is a plus. Knowledge of Inventory Management software a plus. The person must be capable of performing repetitive motions and lifting small to medium sized loads of 30 to 50 pounds. The person must be detailed oriented, dependable, and able to work independently and also in a team environment. In addition, we are looking for a candidate who can pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, culturally diverse organization. Pharmaceutical Packaging -  Working in a pharmaceutical packaging area using: Liquids and blister packs Will be following batch records to run each batch Will be labeling the products Must be able to perform accurate counts of all batches and products Must keep area sterile, clean and organized 1st shift jobs available Previous experience working in a clean, sanitary or regulated environment is a plus

Large pharmaceutical manufacturer is looking for workers in the packaging area.   1st and 2nd shifts available. Pay is $12 - $16 hr   Performs duties related to filling, packaging and warehousing of products (kits) containing various components  Assists and monitors filling, labelling and packaging/warehouse equipment of varying complexity in accordance with SOPs, production batch records and filling records and packaging records Inspects products for defects and conformance with quality standards. Makes judgments regarding quality of product and materials. Interacts with other production teams to ensure production schedules are met. Assists in completing all necessary documentation associated with filling and packaging operations as required. (Batch production records and associated MRP system transactions) to ensure all components meet requirements pertaining to lot numbers, expiration dates , intermediates , reconciliation etc. Understands GMP, QSR, ISO and RMS quality regulations Must be comfortable wearing a full gown when necessary Experience is not required - but must be able to stand for long periods and follow very specific directions   Overtime is available. This is a great way to get into the pharmaceutical industry!  

  Pharmaceutical GMP Auditor Environment: Our client is a Biopharmaceutical company who focuses on the treatment of brain injuries.They will be in need of a GMP Auditor to come in and audit a drug substance manufacturer Job Duties/Responsibilities: Our client is a Biopharmaceutical company who focuses on the treatment of brain injuries.They will be in need of a GMP Auditor to come in and audit a drug substance manufacturer. They will be working with the CMC Manager and the VP of RA/QA during this audit. The consultant chosen for the role will be required to do both pre-audit and post-audit work as well. This person should come from a pharmaceutical background and have extensive experience auditing drug substance manufacturers.  Required: Pharmaceutical/Biologics GMP Auditing Drug Substance Manufacturing Job Type: Contract  

  Pharmaceutical CSV Tech Writer (MES) Project Description: The client is seeking a computer systems validation resource to perform technical writing for the implementation of a new MES system.   Day to Day Responsibilities: This person will be responsible for authoring requirements/documentation as it relates to MES. This individual must have technical knowledge of this system as well as strong technical writing skills. They will primarily be responsible for assisting in the pre-implementation process as well data integrity. They will be responsible for writing test scripts and documentation as well as reviewing test and design documentation. The client has another Labware LIMS system so if this person has experience with both of these it can be very helpful. Required Skills: Computer Systems Validation MES Technical Writing Review test/design documentation Data integrity Desired: Labware LIMS Job Type: Contract

  Pharmaceutical CSV Tech Writer (Labware LIMS) Project Description: The client is seeking a computer systems validation resource to perform technical writing for the implementation of a new Labware LIMS system.   Day to Day Responsibilities: This person will be responsible for authoring requirements/documentation as it relates to Labware LIMS. This individual must have technical knowledge of this system as well as strong technical writing skills. They will primarily be responsible for assisting in the pre-implementation process as well data integrity. They will be responsible for writing test scripts and documentation as well as reviewing test and design documentation. The client has another MES system so if this person has experience with both of these it can be very helpful. Required Skills: Computer Systems Validation Labware LIMS Technical Writing Review test/design documentation Data integrity Desired: MES Job Type: Contract

  Pharmaceutical Process Validation Engineer Environment: Our client is a Pharmaceutical company that specializes in manufacturing pharmaceutical medicines. Our client is in need of a process validation engineer to make minor adjustments and help with design verification to a product that will be submitted to the FDA to begin phase one of clinical trials. Job Duties/Responsibilities: This person will be responsible for providing process validation support to a new product. This consultant will be responsible for performing design verification; upscaling; and has to be a process validation SME to get the product ready to be submitted to the FDA. This consultant needs to be hands-on working in process validation initiatives as well as have a strong background in analytical testing. This client works with coronary products. This consultant needs to come from a technical quality background and be able to work as an individual contributor developing and executing process validation. Required: Pharmaceutical Process Validation Engineer Quality Background   Job Type: Contract

Title: Specialty Sales Representative-Hematology Location: CT/RI Company: Top Global Pharmaceutical Company Compensation: $140k- $160K Base Target Bonus + Excellent Benefits Contact Carrie Pennoyer cpennoyer@smithhanley.com Exciting Opportunity in Hematology/Oncology for Impact, Growth and Exposure at a TOP GLOBAL BIotech Company! ***Please Note: If you apply and do not meet the below requirements you will not be contacted or considered*** REQUIRED: -Currently working in Pharmaceutical Sales and in Oncology/ Hematology! -3 or more years' experience selling Oncology products to Oncologists is required -Minimum 3 years Specialty Pharmaceutical Sales experience is required -Proven track record of success selling in pharmaceuticals -Documented sales results depicting significant success, including examples of national awards for performance, company awards, or participation in management development program are preferred -Residence within the current geography is required -4 year Bachelor's degree from an accredited University required COMPETENCIES: -Demonstrated performance and results -Demonstrated customer and marketplace expertise -Ability to effectively discuss risk/benefits with targeted healthcare providers -Ability to effectively build successful territory business plans to ensure successful product launches. -Professional credibility; demonstrated success in persuasion, influence and negotiation skills -Collaboration within the organization and across multiple teams -Customer Focused with ability to identify, develop and leverage relationships -Team player

Medical Science Liaison - Rare Disease Oncology/Hematology location: Chicago, IL Great Lakes territory ( IA, IL, IN, MI, MN, MO, ND, NE, SD, WI) A fantastic initial product launch opportunity for an MSLs nationwide team buildout in Rare Disease / Oncology at a small public BioPharma company. Breakthrough Therapy Designation (BTD) granted to product near year end 2017 and product launch expected by year end 2018. The company has a ton of buzz around it and has a great signon RSU/Stock Options benefits package! Note: Must have 3+ years of MSL Oncology experience. Qualifications: 1. Terminal degree required (PhD, PharmD, MD/DO) 2. 3+ years of clinical, scientific research or industry related experience in Hematology/Oncology. 3. 3+ years of pharmaceutical MSL Oncology/Hematology experience Details: 1. Competitive Base Salary & Bonus 2. Full-time Benefits including RSUs & Stock options 3. Visa Candidates Not Considered Email your resume to: kkupersmith@smithhanley.com

Medical Science Liaison - Rare Disease Oncology/Hematology industry: BioPharma location: Boston, MA (New England territory) A fantastic initial product launch opportunity for an MSLs nationwide team buildout in Rare Disease / Oncology at a small public BioPharma company. Breakthrough Therapy Designation (BTD) granted to product near year end 2017 and product launch expected by year end 2018. The company has a ton of buzz around it and has a great signon RSU/Stock Options benefits package! Note: Must have 3+ years of MSL Oncology experience. Qualifications: 1. Terminal degree required (PhD, PharmD, MD/DO) 2. 3+ years of clinical, scientific research or industry related experience in Hematology/Oncology. 3. 3+ years of pharmaceutical MSL Oncology/Hematology experience Details: 1. Competitive Base Salary & Bonus 2. Full-time Benefits including RSUs & Stock options 3. Visa Candidates Not Considered Email your resume to: kkupersmith@smithhanley.com

Medical Science Liaison - Oncology / Hematology Industry: BioPharma location: California - West Coast Territory (AK, CA, HI, ID, MT, NV, OR, WA, WY) A fantastic initial product launch opportunity for an MSLs nationwide team buildout in Oncology/Hematology (Rare Disease) at a small public BioPharma company. Breakthrough Therapy Designation (BTD) has been granted and product launch expected by year end 2018. The company is public with great press reviews and offers a great signon RSU/Stock Options benefits package! Note: Must have 3+ years of MSL Oncology experience. Qualifications: 1. Doctorate degree required (PhD, PharmD, MD/DO) 2. 3+ years of pharmaceutical MSL Oncology/Hematology experience Details: 1. Competitive Base Salary & Bonus 2. Full-time Benefits including RSUs & Stock options 3. Visa Candidates Not Considered Email your resume to: kkupersmith@smithhanley.com

Smith Hanley Associates Principal Biostatistician Greater Los Angeles area $130k - $150k salary range Nihar Parikh - nparikh@smithhanley.com This is a great opportunity to join a midsize biotech that plans to double in size in the next few years and offers an entrepreneurial environment, great work life balance, and visibility to leadership. Responsibilities: In this role you will serve as the SME for statistical methodology and provide the organization with guidance on regulatory compliance, study design plans, clinical validation, product development and research. Develop statistical procedures for regulatory submissions, publications, and process improvements. Establish statistical methodology on product development, clinical and analytical studies, validations, and process improvements. Partner with cross functional teams on technical topics and communicate statistical issues. Qualifications: Degree in Biostatistics, Mathematics, Statistics, or related field. Advanced degree a plus. Seeking candidates with pharmaceutical industry experience and expertise with statistical analysis plans, clinical development, regulatory guidelines, technical standards and SAS programming. Experience in clinical trial design, FDA regulations, product development and statistical methodologies. Proficiency with data collection, data mining techniques, statistical quality control and the ability to draw conclusions based on analysis. Must be comfortable working independently with limited supervision. Smith Hanley Associates is a niche recruiting agency. Please visit our website at www.smithhannley.com

Title- Director, Payer Analytics Lead-PHARMA Location- Los Angeles, CA Area Salary- Depends on Experience Consultant- Eda Zullo, ezullo@smithhanley.com My client, a Global Pharma Company, is seeking a "Director, Payer Analytics Lead-PHARMA" Professional! This position a SENIOR LEADERSHIP role in which you will be responsible for leading the Payer /Market Access/Managed Markets ANALYTICS Group. Responsibilities * For driving the strategy and leading the analytics that will inform the businesses on how the changing healthcare policy will affect the pharma landscape. *Provide leadership and innovation as it speaks to payer and product performance, reimbursement, etc. *Keep the leadership informed to any changes in the market access space nationally *Be current on customer segmentation insights and product performance measurement Requirements *Outstanding Leadership and relationship building skills *Must be a STRATEGIC thinker with a proven history * Must be extremely analytical and a critical thinker *Command a room presence *Respected in the industry *A true understanding and proven knowledge of the Payer, Provider, Employer, PBMs, Specialty Pharmacy, Distribution, Patient Services, ACOs, IDNs; AND Knowledge of the managed care environment and reimbursement

Smith Hanley Associates Senior Biostatistician Morris County, NJ Nihar Parikh, nparikh@smithhanley.com Responsibilities: -Lead statistical programmers, statistical analysis plans, and quality control of statistical deliverables -Provide statistical analysis and consulting, research statistical methodologies -Manage CRO's and clinical study resources -Support regulatory submission deliverables, sample size calculations, and study programs Qualifications: -MS/PhD and 3+ years' experience in the pharmaceutical/biotech industry required -Experience in statistical methodology, drug development and regulatory guidance -Experience in SAS programming, SOP's, and strategic plans -Experience in advanced statistical concepts and quality control -Familiarity with pharmacology www.smithhanley.com

Smith Hanley Associates Senior/Principal Statistical Programmer Bethesda, MD area Nihar Parikh - nparikh@smithhanley.com Provide statistical programming support for drug products including analysis and reporting, regulatory submissions, commercialization, and technical standards. Responsibilities: -Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and Oncology projects. -Deliver CSR SDTM/RDB databases as well as tables, listings and figures results. -Provide statistical programming, analysis and reporting, as well as information infrastructure and statistical methodologies. -Maintain technical database standards and programming specification documents. -Develop best practices, monitor safety/efficacy of data, and implement innovative solutions. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -Oncology experience and a background in pharma or healthcare. -Experience in clinical drug development, regulatory requirements, CDISC standards, and data submission. -Experience in statistical programming, report publishing, and the ability to define business processes. -Strong SAS programming; Exposure to R, SQL, etc. a plus. www.smithhanley.com

Smith Hanley Associates Manager, Biostatistics San Francisco Bay Area, CA Nihar Parikh - nparikh@smithhanley.com Oversee statistical aspects of study design, analysis, validation and study documentation as well as programming with external vendors. Responsibilities: -Provide statistical expertise to clinical development projects. -Develop statistical analysis plans, perform data analysis and validation. -Manage CRO's, assist in the publication of study data. -Develop and validate data systems and work with teams from data management and clinical operations and analysis. -Provide clinical study design and analysis strategies. Qualifications: -MS or PhD in Biostatistics, Mathematics, or similar field required. -Proficiency with statistical analysis, clinical programs, drug development guidelines, and regulatory submissions. -Pharmaceutical background and experience in clinical trials. -Experience with SAS programming, CDISC models, and data standards. -Experience contributing to NDA/BLA's and supporting publications. www.smithhanley.com

Smith Hanley Associates Associate Director, Biostatistics Morris County, NJ Nihar Parikh, nparikh@smithhanley.com Oversee statistical aspects of clinical studies and submissions, collaborate with clinical and regulatory leads, create clinical plans, and develop statistical approaches. Responsibilities: -Execute statistical analysis, clinical study reports, and provide clinical and regulatory guidance -Manage direct reports, clinical development plans, and statistical deliverables -Implement technical data standards and data collection as well as work with cross functional teams -Adhere to regulatory requirements, department guidelines, and compliance procedures -SAS programming, data models, and data package submissions Qualifications: -MS/PhD and 5+ years experience in the pharmaceutical/biotech industry required -Experience in statistical methodology, clinical research, drug development and regulatory guidance -Experience in SAS programming, clinical trial methodologies, strategic plans, and clinical study design -Experience in Neuroscience or Pain therapeutic areas and clinical trials -Experience in drug submissions, life cycle management, and advanced statistical concepts -Previous management experience www.smithhanley.com

Senior Medical / Science Director Neuroscience Location: Chicago, Illinois Industry/Department: US MEdical Affairs - Pharmaceutical / Biotech - R&D Role Overview: 1. Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: a. Health-care professional/provider interactions b. Generation of clinical and scientific data (enhancing therapeutic benefit and value) c. Educational initiatives (medical education, data, guidelines and value proposition) d. Safeguarding patient safety 2. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. 3. Provide scientific and technical support for assigned products a. Deliver scientific presentations b. Develops professional and credible relationships with key opinion leaders c. Actively participate with Brand Teams and helps develop medical affairs strategies d. Develop innovative research concepts for clinical data generation e. Provide relevant scientific and technical training. Responsibilities: 1. Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. 2. Oversees the design, risk management and executions of clinical trials and is medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. 3. All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or to generate data for label inclusion. 4. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc) as they relate to on-going medical affairs projects. 5. Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. 6. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development. 7. May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. 8. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. Qualifications: 1. Medical Doctorate (M.D.) degree or equivalent with Neurology therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred. 2. National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. 3. Minimum of 2 years (3+ preferred) of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 4. Proven leadership skills in a cross-functional global team environment. Ability to run a clinical study or medical affairs team independently including regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. 5. Must possess excellent oral and written English communication skills. 6. Additional Spanish or Portuguese launguage preferred. Details: 1. Visa Candidates Not Considered 2. Competitive Base Salary 3. Full-time Benefits 4. Relocation Assistance Available 5. 2+ to 5 years of experience 6 Medical Doctorate Degree Required Contact: kkupersmith@smithhanley.com

Job Description: No Per Diem Available Job Summary: The Metrology Instrumentation Tech ensures customer satisfaction through excellence in repair and support of customer’s products. Maintains communication with customer to ensure understanding of status, cost, and timing of all aspects of the service event. Serves as a customer advocate and ensures that technical issues are resolved in a timely manner. Performs initial technical diagnosis of operational problems and repairs/calibrations on wide range of laboratory equipment to ensure that the equipment is operating to the customer’s satisfaction and manufacturer specifications. Assists with customer training by preparing instruments and supplies as well as giving presentations. Enters various types of data (i.e. service log, invoicing, knowledge retention, etc.) into computer system. Supports the Quality System and Quality Policy by following procedures/work instructions and creating records to meet the requirements of the Quality System Regulation and ISO registration. Maintains spare parts inventory, tools, manuals and test equipment. Maintains records of service events per organizational policy.

Join this " progressive" and innovative international based pharmaceutical sales company as their next Sales Representative in the Portland, OR-Vancouver, WA metro territory. My client can offer you: -An Excellent training program and resources to succeed. -A strong R&D product line. -Career Advancement opportunities to become a District Sales Trainer; District Sales Manager; or Home Office Opportunities in a 3-5 year period of time based on your performance and ability to relocate for promotions. -Strong work/life balance. -$60, 000-$75, 000-$90, 000 Base Salary (DOE) + Bonus $25, 000-$30, 000> + Auto & a very comprehensive benefits package. Experience Desired: -BA/BS Degree - Activities/Leadership on campus. NCAA Sports a plus. -2 years-10+ years of successful pharmaceutical sales experience. -The hiring manager is very open to candidates looking to relocate on their own accord (the last hire by this manager relocated from Phoenix, AZ). -Mid December hiring time line; January 22, 2018 starting date. IND123