(US-Massachusetts-Boston) Plan and project manage the cross-functional activities associated with deplying EDC for individual clinical trials and/or registries. Facilitate the rollout of EDC program to a broader mix of trials, with special emphasis on training. Interact closely with functional area to acheive buy-in, ownership and process change. Major Activities of the position in order of importance are as follows: Project Management - Plan EDC activities and assign reponsibilities to support project milestones - Track progress and report/escalate issues as needed - Prepare, run and follow up for EDC project meetings - Work with EDC vendor on project related tasks Process Change - Propose, develop and secure buy-in for standards, conventions and process improvements - Work with relevant functional areas to implement EDC related SOPs - Work with HR on EDC related change management
(US) For an exciting pharma client! PhD in Pharmaceutics or related (not analytical or organic) with dosage formulation and design or product development experience. Preferably injectible and/or oral dosage.Qualification studies, tech transfer. Interact with project teams; provide technical support to plant. Transfer new technology to plant.
(US) Midwest client develops, manufactures and markets immunoassay and Elisa detection kits for use by the research community. Client also provides luminescent products, antibodies and proteins. Client is seeking to fill a hands-on QC management position--level to depend on candidates credentials. MAJOR RESPONSIBILITIES: 1. Total responsibility for Quality Control, to include planning, financial, and staff management. 2. Accountable for ensuring product quality. SPECIFIC DUTIES: 1. Manage all Quality areas utilizing the necessary personnel to complete the following: o Establish and maintain vendor qualification criteria. o Receipt and inspection of incoming raw materials. o Validation of new or modified products. o Testing, analyzing and monitoring of in-process and finished materials and their stabilities. o Writing, improving, and monitoring products, procedures, and test methods. o Establish and maintain ISO guidelines and compliance. o Establish and maintain company-wide calibration methods and procedures. 2. Perform the following managerial duties: o Lead and motivate the necessary personnel to maintain production levels effectively; to include hiring, reviews, promotions / demotions, compensation, etc. o Long range planning for departmental needs based on interactions with the Planning Group. o Schedule personnel and, where necessary, help personnel complete tasks. o Maintain team spirit and cooperation of all Production personnel. o Participate in the product development process to result in an increased number of high quality products. 3. Perform the following related duties: o Conduct assays as required. o Plan and assist with positive departmental and company growth. o Interact with all departments concerning product manufacture and quality. o Other product oriented functions as needed. MINIMUM REQUIREMENTS: 1. B.S. or B.A. in a scientific field (i.e., Biology, Biotechnology, Chemistry, etc.) 2. 3+ years experience in the Quality area in a relevant diagnostics industrial setting. 3. 5+ years experience with immunoassays from a manufacturing perspective. 4. Strong background in statistics as related to immunoassay materials and results.
(US-Michigan-Ann Arbor) This full-time position is for a dedicated, responsible person to ensure that formulation, production, and manufacturing operations are performed in accordance with Federal and State regulations. Responsibilities include ensuring compliance to company procedures, current Good Manufacturing Practices, current Good Laboratory Practices, and applicable ICH guidelines. This individual will also be responsible for ensuring accuracy of all CMC-related regulatory submissions to US and foreign agencies along with developing and managing the objectives and activities of the QA/QC Department. Candidates are expected to have a PhD + 6 years, a MS + 10 years, or a BS + 12 years of experience.
(US-Massachusetts-Framingham/Worcester) Recruiting a regulatory affairs specialist for a research-based pharmaceutical company (near Marlborough, Massachusetts) dedicated to treating and preventing human disease through the discovery, development, and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. They provide a supportive work environment for their employees - recognizing and rewarding outstanding performance. They treat each other with mutual respect and consideration. This position offers excellent opportunities for career growth and outstanding financial rewards. Job Description: The selected candidate will prepare routine submissions for IND products under development, including various reports and other IND or NDA related amendments and/or supplements. This person would also participate in project team meetings and coordinate regulatory submissions with CROs and interface with Clinical Operation, Medical Affairs, Preclinical, and Chemistry and Manufacturing disciplines for regulatory requirements, strategy and submissions. In addition, this individual will review final clinical and preclinical study reports, respond to FDA queries and other related documents. The Regulatory Affairs Specialist will provide all the basic support to successfully and timely accomplish all the various regulatory functions. Requirements: BS or BA in Chemistry, Biology, Biochemistry, Pharmacy or Nursing or related field. At least 2 to 4 years experience in preparing pharmaceutical regulatory submission to FDA including INDs, NDAs and related amendments, supplements, adverse event reports, and a desire to work towards the development of safer and better pharmaceutical products. Must have working knowledge of Federal drug regulations and prior experience in biotechnology or pharmaceutical regulatory affairs. Experience or knowledge of Canadian or European or worldwide Regulatory Authorities or guidelines is a plus.
(US-Massachusetts-Framingham/Worcester) Recruiting a senior director, toxicology for a research-based pharmaceutical company (near Marlborough, Massachusetts) dedicated to treating and preventing human disease through the discovery, development, and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. This position offers excellent opportunities for career growth and outstanding financial rewards. Job Description: The selected candidate will actively participate on drug development teams, including toxicology program and study design, dosage selection, study initiation and monitoring, report review and finalization. Responsible for leading risk assessments and for regulatory interactions. Also responsible for literature reviews, critical evaluations of in-licensing opportunities, and data summaries and presentations. Determine toxicology studies needed to support development projects. Initiate studies at approved contract facilities following appropriate processes for protocol development, contract implementation, test article procurement, and time-line commitments. Monitor studies for accuracy and timely completion, and review draft reports for completion and consensus of opinions. Prepare verbal and written summaries of study reports for internal discussions and for regulatory submissions. Coordinate tasks across departments for efficiencies and synchronization to support team objectives. Anticipate problems and opportunities and raise issues and suggested resolutions to supervisor or appropriate team leader. Management of staff at multiple contract facilities must be carefully addressed in order to ensure the timing requirements of the internal project teams. Contributions to, and cross-functional review of, various regulatory documents requires careful time management, mature communication and diplomacy skills, and attention to continuing improvements in existing processes. Position may include supervisory responsibilities. Requirements: Ph.D. or equivalent in Toxicology, Pathology, Pharmacology, Chemistry, or related health science field. Board Certification (e.g. DABT, ACVP) desired but not essential. Ten or more years of experience in pharmaceutical nonclinical safety evaluation required, with at least 3 of those years including responsibilities for risk assessments, FDA interactions and project decision making. Working knowledge of GLP regulations, ICH guidance documents and experience conducting and monitoring toxicology studies essential. Strong oral communication skills and demonstrated proficiency at technical writing are essential. Working knowledge of drug metabolism and/or kinetics would be a plus. Demonstrated leadership/supervisory strengths desired. extensive interactions across departments and external study monitoring responsibilities require solid time management and effective communication skills. This position requires an individual with excellent organizational, written and oral communication skills, high degree of self motivation, and effective problems solving skills in addition to time management, task management and mature communication and team skills are essential. As all studies are conducted externally, a fair amount of traveling (e.g. 10-20%) could be expected, depending upon project assignments.
(US-Massachusetts-Boston) Recruiting a senior biostatistician for a company that provides clinical trials support for therapeutic, biologic and medical device products near Boston, Massachusetts. They provide a supportive work environment for their employees - recognizing and rewarding outstanding performance. They treat each other with mutual respect and consideration. This position offers excellent opportunities for career growth and outstanding financial rewards. Job Description: Under minimal supervision, the Senior Biostatistician is responsible for: working on highly complex projects suggesting analyses, compiling reports, charts and tables, interpreting results based on established statistical methods; participating in the design and review of clinical protocols and case report forms (CRFs), participating in database design, data collection guidelines, and logic checks; managing the generation and implementation of prospective analysis validation plans; implementing analysis plans; providing guidance and training to Biometrics staff; writing and reviewing statistical reports; designing and managing the generation of randomization schedules. Required qualifications: Ph.D. in Biostatistics or related discipline and 2 years of industry experience, or M.S. with a minimum of 4 years industry experience. Must also have: advanced computer skills with extensive experience in SAS, StatXact, and nQuery; strong written and oral communication skills; proven leadership skills; good time management skills; ability to prioritize, meet deadlines and multitask; the ability to work independently and as a team member. Preferred qualifications: Ph.D. in Biostatistics and 3+ years industry experience including 2 years in a CRO; experience as a mentor, team leader or manager.
