Senior Manager, Medical Information (MA)

The Senior Manager, Medical Information will assist the Associate Director of Medical Information in managing the Medical Information Department and its related responsibilities, including the handling of medical information requests for Company's marketed products, received from healthcare professionals (MD's, DO's, PharmD's, RPh's, RN's/LPN's, RT's, amongst others), sales representatives, consumers and others (including other Company employees). The Sr. Manager, Medical Information will assist the Associate Director of Medical Information in managing the following: Handling of all incoming medical inquiries re: any of Company's marketed products from healthcare professionals, sales representatives, consumers and others; Development of standardized responses to frequently asked questions re: any of Company's marketed products; Update of standardized responses to frequently asked questions re: any of Company's marketed products, on an ongoing basis; Handling of incoming requests from co-marketing partners (including Ross and MedPointe); Train Company Sales Representatives and other internal personnel on Medical Information and its related policies/procedures; Maintain and periodically audit the medical information database (IRMS) for tracking receipt and responses to medical information requests; Disseminate detailed periodic reports (on a weekly, quarterly and yearly basis) of medical inquiries processed by department to various internal Company employees; Develop a document management system for the most frequently utilized references; Staffing of Medical Information booth at various scientific meetings identified and management of all related activities; Perform literature searches for Company marketed products; Collate, summarize and disseminate pertinent literature to Company internal personnel and field sales force; Review competitor medical information and prepare summaries as requested; Interact with the Marketing Department (and other departments, including Sales Training) on literature dissemination to the sales force.

Minimum of a Bachelor's of Science degree in Pharmacy or Nursing. Doctorate of Pharmacy (PharmD) degree preferred. Minimum of 3-6 years within the pharmaceutical industry, with at least 2 years experience within Medical Information. For those with a PharmD degree and 1-3 years pharmaceutical experience that have completed a residency within Medical Information OR have 1 year experience within Medical Information, would be considered. Must have excellent oral, written, organizational and planning skills, be detail oriented and have familiarity with PC based applications, including Microsoft Word, Excel and PowerPoint.

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Contract QA associate (NJ)-six month assignment

Reviewing batch records for GMP compliance under the direction of the QA Manager, identifying errors and missing information in the batch record and arranging meetings with production personnel to correct the errors and obtaining review signatures, identifying deviations and reporting them to the QA Manager and Compliance department, testing report forms for in-process, release and product stability, reviewing documents for accuracy, GMP compliance and validity, comparing results to current specifications to assure product quality and assisting in additional tasks as required.

BS in life sciences preferred. Must be computer literate in MS windows based applications. Must be able to speak, read and write English to understand and comply with written procedures, instructions, SOPs and other documents. Accurate record keeping, documenting and organizational skills are a must. Candidate must be able to perform in a fast paced environment and have excellent communication skills.

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Contract QA associate (NJ)-six month assignment

Perform incoming inspections of all GMP controlled raw materials, sampling and submission of samples for testing as needed, prepare purchase orders as related to submissions to contract facilities, labeling of GMP raw materials, adhere to FDA/cGMP regulations as well as SOPs, assist in the processing/reviewing of all incoming Raw Material Specifications related documentation and assist with additional tasks as needed.

BS in life sciences preferred. Must be computer literate in MS windows based applications. Must be able to speak, read and write English to understand and comply with written procedures, instructions, SOPs and other documents. Accurate record keeping, documenting and organizational skills are a must. Candidate must be able to perform in a fast paced environment and have excellent communication skills.

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Contract & Permanent CRAs (NJ)-several positions for 6 months to 1 year assignments

NOTE: Based out of HQ

Monitor and manage all clinical trials Phase 1-3 according to current regulations, GCP and SOP requirements. Key responsibilities are to identify and propose potential trial investigators, negotiate site trial agreements including budgets and contracts, assure timely availability of all trial materials and documentation at trial site, obtain and maintain trial master file documents, participate and train at investigators meetings as appropriate, perform source document verification procedures according to SOPs and trial specific requirements, ensure CRFs are provided to centers and are complete, legible and accurately reflect the source data, ensure appropriate reporting of adverse events by investigators according to GCP and SOPs, ensure investigator and other site personnel compliance with the protocol and trial procedures, train on-site team of the investigator and other site personnel in proper conduct of clinical trials, perform qualification, initiation, monitoring and close up tasks as required by GCP, SOPs and study protocol, review CRFs and request corrections of entries as required, monitor SAE reporting and request primary and follow up information according to SOP, review protocol violations with the investigator and take corrective actions to prevent continued non-compliance, provide timely monitoring reports in accordance with SOPs, input into CRF design, prepare and review amendments and ensure appropriate approvals from sites, verify shipment of study supplies and assist with additional tasks as required.

BS or BSN with minimum of 5 years of experience or MS with 3 years. Must possess a thorough understanding of GCP, the clinical trial processes and internal SOPs. Must be able to work in a team environment. Must be fluent in spoken and written English. Should have excellent organizational skills with the ability to prioritize multiple projects and tasks. May lead and direct the work of others. Computer literacy, familiarity with MS Office and MS project preferred

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Associate Director, Clinical Affairs (CA)

Responsible for strategic operational management of portfolio of clinical programs in Medical Affairs. Effectively leads a team of Clinical Affairs Managers to meet project goals and attain deliverables in all phases of clinical programs. Facilitates cross-functional partnerships internally and externally to Medical Affairs. Manages alignment between the Unit and the Product Development Project Team Structure in the areas of budget, resources and timelines. Ensures excellent management of the Clinical Affairs, and Clinical Research Professional job family within Unit and across Medical Affairs. Effectively partners and provides resources to ensure the successful implementation of Medical Affairs Strategic Initiatives.

BS/RN/MS degree in biological science, health science or equivalent; MBA or other advanced degree desirable. Minimum 10 years experience in clinical research. Minimum 5 years experience staff management, including leading other managers. Robust experience in planning, resourcing and managing multiple, complex, multifaceted clinical programs, phase I-IV

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Senior Biostatistician (Massachusetts)

This position provides statistical input into Phase II, III and IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Provides statistical input into protocol/CRF development in all therapeutic areas at Company (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, query checks for clinical trial data). Write detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety. Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output. Accurately interpret and clearly communicate statistical results and concepts to non-statisticians. Co-author final integrated reports of clinical trial data writing thorough and clear statistical methods sections and producing the statistical appendix for the reports. Provide statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications. Provide input into statistical SOPs and general standardization efforts within the department (e.g. statistical methodology standards, standard data presentations. Participate in interactions with regulatory agencies as required. Collaborate effectively with members of clinical trial implementation teams and with Biometrics colleagues.

Requirements: PhD with 3-5 years of Pharmaceutical/Biotechnology experience

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Associate Director, Biostatistics (Massachusetts)

We have a key management opportunity for an experienced Associate Director for Biostatistics. You will oversee the development and evaluation of analysis plans and directs statistical analysis for four registry programs in a post-approval setting while managing several other people within the Biostatistics department. The candidate will be the statistical leader of the registries group, responsible for meeting both regulatory and marketing objectives within the programs; providing innovative statistical methods and analyses that will have high visibility and impact within the company. The ideal candidate will establish and maintain direction of the biostatistics organization through strategic planning, coach and supervise staff in project decision making, and oversee the design, development, modification and evaluation of a technical infrastructure.

Requirements: Ideal candidates should have Ph.D. in Biostatistics or Epidemiology with at least 5 years of experience or Masters Degree with at least 8-10 years of experience and strong technical skills. The successful candidate will have strong quantitative skills, including longitudinal data analysis and statistical programming with a preference given to SAS. Successful staff management experience with collaborative communication and interpersonal skills is required.

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Associate Director, Biostatistics (NJ)

Responsible as a lead statistician. Participate/support development of clinical program. Review protocols & case report forms for soundness of trial design. Write statistical methodology section of the protocol. Prepare analysis plan and programming specifications. Perform inferential analyses. Write the statistical section of the clinical trial report and review clinical trial report. Support/participate in drug project related activities including preparation of global HA submissions. Oversee CRO deliverables for trials contracted out. This position is for Company Pharmaceuticals Corporation

MS in Statistics with at least 9 years of pharmaceutical experience or PhD in Statistics with at least 5 years of pharmaceutical experience. Strong statistical and data analysis skills; knowledge of clinical trial methodology. Solid hands-on experience as a lead statistician in clinical development program. Solid experience in supporting NDA submissions. Strong ability in protocol development, analyses and clinical trial reports/publications for Phase II-IV clinical trials. Good knowledge of drug development process. Very good oral and written communication skills. Knowledge of FDA/ICH guidelines. Good knowledge of SAS computer package. Good project management

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Associate Director, Biostatistics (NJ)

Apply pharmacokinetic/pharmacodynamic (PK/PD) modeling, population pharmacokinetic modeling, physiological modeling, clinical trial simulation, and related techniques in support of early clinical development (until Proof-of-Concept) and full clinical development (until submission to Health Authorities). Provide support at the trial level with regard to study design, analysis, and reporting. Provide support at the project level with regard to the elaboration and implementation of the PK/PD concept for the project, strategic decision making based on modeling and computational input, and preparation of NDA integrated summaries of clinical pharmacology, effectiveness, and safety. Support project statisticians and pharmacokineticists with regard to modeling and related activities. Support or interact with the Methodology Group in areas of expertise. May participate in/or lead non-clinical projects activities (e.g. development of global standard procedures, application of new modeling methods and related computational aspects).

Master’s Degree in a modeling-related field with at least 9 years of related experience, or Ph.D. in a modeling-related field with at least 5 years of related experience.

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Statistician (Europe with excellent global relocation)-Several positions

Be responsible for all statistical tasks on the assigned clinical trials, e.g., clinical trial design/planning, analysis plan, reporting activities, exploratory analyses and additional analyses to support publications, and statistical consultation during the running phase. Track clinical trial activities and milestones. Ensure timeliness and adequate quality of all deliverables for the assigned trials. Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and regulatory guidelines). . Establish and maintain sound working relationships and effective communication within the clinical trial team and the team. Participate in non-clinical project activities as needed.

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Senior Statistician (Europe with excellent global relocation)-Several positions

Be responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase. May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability. Track clinical trial/allocated project activities and milestones. Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and regula-tory guidelines). Participate in or lead non-clinical project activities as needed. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/International Clinical Team and the team.

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Expert Statistician (Europe with excellent global relocation)-Several positions

Be the statistical leader and project manager for all deliverables globally for a clinical development program, or a mega trial. Ensure that clinical development program (or parts assigned) meets scientific, reg-latory, quality, and commercialization requirements, through interaction with the IPT and ICT. Perform matrix management of team, and mentor staff as required. Ensure modeling and simulation contribution is fully integrated into the project. Plan and track project level activities, including resources. Establish and maintain project standards (master analysis plan, full development project specifications). Plan and manage submission activities, like SCS, SCE, briefing books. Participate in/lead non-clinical project activities. Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings. Could take Trial Statistician responsibility as appropriate.

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Senior Expert Statistician (Europe with excellent global relocation)-Several positions

Be the independent statistical leader and project manager for all deliverables globally for a large and technically complex clinical development program, including supervisory functions like appraisals of full-time team members. Ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements, through interaction with the IPT and ICT (e.g., drive CDP and TPP development from a statistical perspective). Be a scientific leader/expert within a Therapeutic area, showing leadership/be the point of reference in statistical methods, regulatory guidelines, project strategies, clinical development planning and study design in specific indications. Perform matrix management of project team, and mentor staff as required. Ensure quality of scientific contributions, integrating input from Biostatistics, Methodology, Modeling and Simulation and external experts. Initiate and drive innovation by implementing novel methods and innovative designs. Plan and track project level activities including resources. Establish and maintain project standards (master analysis plan, full development project specifications). Plan and manage submission activities, like SCS, SCE, briefing books. Participate in/lead non-clinical project activities. Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Take significant Biostatistics leadership role at FDA Advisory Committee meetings. Evaluate in licensing opportunities.

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Statistical Programmer (Europe with excellent global relocation)-Several positions

Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities. As required, make certain that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF, data structures, specifications of analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I – IV clinical trials. Program, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for SCS and SCE. Track clinical trial milestones for SR deliverables. Maintain records for all assigned projects including archiving of trial analysis and associated documentation. Support senior members of SR and program statisticians in maintaining efficient interfaces with internal and external customers. Comply with pre-defined project / study standards and specifications. Support SR colleagues in non-clinical initiatives.

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Senior Statistical Programmer (Europe with excellent global relocation)-Several positions

Lead the programming activities for a trial, early phase project, indication, or publication activities; lead a complex/large project under supervision of a Program Statistician / Group Head. Maintain efficient interfaces with internal and external customers with support of SR management and the Program Statistician. Develop resource plans as required with support of the Group Head. Develop and comply with project / study standards and specifications following internal guidelines. Make certain that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities. Program, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for SCS and SCE with high quality and within milestones. In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings. Support quality control and quality audit of deliverables. Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation. Participate in the selection of CROs and supervise the SR trial activities of the CROs. Provide input on process improvement initiatives and participate in non-clinical project activities.

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Principle Statistical Programmer (Europe with excellent global relocation)-Several positions

Manage the programming activities for a global project following internal project management guidelines including resource planning. Act as Program Programmer for assigned projects and take a programming leadership role on the project team. Maintain efficient interfaces with internal and external customers with advice from SR management. Develop and comply with project / study standards and specifications following internal and regulatory guidelines. Oversee programming style, quality of SR contributions and compliance with timelines. Provide SR input and lead sections of Full Development and Submission Working Groups. Ensure that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures. Program, according to specifications, analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE. Ensure quality control and quality audit of deliverables. Maintain records for all assigned projects and archive trial / project analysis and associated documentation. Participate in the selection of CROs, as required, and supervise SR project activities for CROs. Train staff on trial and project level activities and internal processes. Participate in or lead non-clinical project activities.

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Senior Principle Statistical Programmer (Europe with excellent global relocation)-several positions

Act as independent Program Programmer for assigned projects, take a programming leadership role on the project team. Act as a deputy for Group Head on key projects. Maintain efficient interfaces with internal and external customers consulting SR management for high level strategic advice. Manage complex projects. Oversee programming style, quality of SR contributions and compliance with timelines. Develop and implement project / study standards and specifications for complex projects in compliance with internal and regulatory guidelines. Plan resources for key sub-areas within SR (e.g., TAs). Ensure that the study protocol and CRF are consistent and comply with company standards. Program analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE according to specifications. Participate in the selection of CROs and supervise SR activities for CROs. Keep up-to-date with state of the art programming techniques. Induct, supervise (matrix) and train programmers on programming skills, trial and project level activities, and internal processes.

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Expert Statistician, Clinical Pharmacology (Switzerland)-Various opportunities
This key individual will provide statistical support, strategic insight, operational guidance and coordination for assigned drug projects. To act as a member in the International Clinical Teams of clinical projects lead by Department; the tasks include statistical study design, especially for Proof of Concept studies, protocol preparation and the initiation of clinical trials, the statistical analyses and the preparation of the statistical sections for clinical trial reports and providing statistical input to documents in support of decision making. To contribute with innovative statistics which may involve the development of novel statistical procedures, the adaptation and implementation of a novel but existing procedure to a study or project and the implementation of new processes. In depth knowledge and expertise in statistics and its applications to clinical trials and their PK/PD parts. Solid knowledge of drug development process and HA guidelines especially in regard to Clinical Pharmacology and PK. Background medical and pharmacokinetics knowledge. Good working knowledge of statistical software packages. Good data exploration and modeling skills. Very good communication and presentation skills. Ability to give guidance to trial statisticians. Good team worker. Good business ethics. Fluent English, oral and written.

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Entry level Medical Writer (NJ)-several positions
Prepare clinical study reports according to ICH guidelines; prepare regulatory summary documents such as integrated summaries of efficacy and safety, annual reports and investigator brochures; interpret statistical analyses for clinical significance; review and provide input on study protocols, statistical analysis plans, and other regulatory clinical documents such as investigator brochures and annual IND updates; write scientific abstracts, manuscripts and posters for therapeutic area conferences.

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Clinical Contracts Manager (NJ)
This key individual will work to obtain/negotiate cost-effective contracts for external clinical research and laboratory services, manages the vendor selection process, act as team leader in evaluating and selecting providers for outsourced services, initial develop, negotiate various clinical agreements, change orders, and amendments for outsourced services. Additionally, will monitor selected CROs to monitor for quality and interact with QA, company sites, and the CRO to evaluate and improve quality. This person will also be responsible and accountable for the successful implementation of individual high value outsourcing business improvement projects within his/her assigned area of development. This person will lead the project from concept to launch, facilitate the team process, collaborate with cross-divisional project teams and execute the project plan, act as liasion between the project office, business sponsor(s), and the organization, and monitor the progress of the project. We require at least 3 years of experience in the pharmaceutical industry with emphasis in negotiating contracts. This person will have an understanding of the clinical research process and demonstrate the ability to interface with clinical researchers and CROs. BA degree in Science or Business, MBA or a law degree.

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Clinical Safety Associate (NJ)-several positions
The Medical Reviewer reviews safety data from case report forms, interfaces with the clinical team and generates safety-related queries. This includes assuring and tracking 100-day medical review, coding all adverse events, collecting and reporting serious adverse events and ensuring the SAE database match. This person provides training on safety and CRF completing at investigator meetings, writes patient narratives, addresses data management queries, reviews protocols for safety elements and serves as Safety contact for SAEs in the protocol. We require at least two years of experience in drug safety with an RPh, PharmD or a health science degree.

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Pre-Clinical Development Manager  (NJ)                                                                                                          Responsibilities include managing a team of scientists and associates to provide bioanalytical support for toxicology studies and clinical trials; overseeing all work performed and maintaining extensive knowledge in current and emerging therapeutic drug monitoring techniques and regulations; directing the performance of laboratory tests in the phamacokinetics laboratory; directing the development, implementation and validation of immunoassays (flow cytometry and ELISA), managing the day-to-day operations of the laboratory; ensuring the performance of all quality management procedures as required by GLP and GCP and assisting in other tasks as required.  PhD with 3 years experience preferred but will consider MS with 5+ years.  Must have previous management experience working with immunoassay development, ELISA and flow cytometry.  Must have experience managing a GLP bioanalytical laboratory analyzing biological samples from clinical trials or toxicology studies.

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Director, Regulatory Affairs (MA)                                                                                                                         Responsible for regulatory aspects of External communications including Ad/Prom activities for all products in the company including management of a staff or regulatory professionals. Responsible for leading group charged with reviewing external communications materials, sales and marketing, training and communication strategies for compliance to current regulations and guidance. Will represent the regulatory department with corporate senior management and provide advice on regulatory issues specific to external communications that affect the business of the company. Represents the company to outside customers and agencies and makes presentations on current regulatory issues pertaining to Advertising and Promotional activities.
Will work closely with senior personnel in Marketing, Corporate Communications and Legal to support commercial interests and registration activities of business. Will participate in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations. Provides strategy and risk assessment analysis to business units with regard to external communications. Responsible for developing long- and short-term planning and supervision of regulatory projects which impact the company's business plan. Candidate will be responsible for taking lead in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials and other external communication with references to regulatory compliance. 5-10 years regulatory experience including knowledge and experience with promotional labeling and advertising regulations. Must be proven leader with management experience. BS or higher.

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Sr./Statistical Programmer (NJ)
The candidate will provide quality statistical programming support for clinical trials conducted for regulatory submission to government agencies; will work with and assist statisticians in the summary of clinical trial data for clinical trial reports, including summary tables, data listings and figures and assist in additional tasks as needed. BS or MS with a minimum of 5 years experience in industrial clinical trial experience. Good verbal and written communication skills, good interpersonal skills and proficiency with statistical software, particularly SAS, are essential.

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Biostatistician (NJ)
Reviewing protocols and case report forms for soundness of the clinical trial design; writing statistical methodology sections of the protocols; preparing statistical analysis plans and computer programs; collaborating with clinical research scientists, clinical research associates, clinical data managers and medical writers to provide statistical support for regulatory submission to government agencies; cleaning databases, analyzing data; writing/reviewing the statistical sections of clinical trial reports; presenting and defending statistical results to government agencies and assisting in additional tasks as needed. Ph.D. in Statistics or Biostatistics with 3-5 yrs of industry clinical trial experience. Excellent verbal and written communication skills, excellent interpersonal skills and proficiency with statistical software, particularly SAS, are essential. Knowledge of current U.S. and international regulatory requirements that relate to statistical considerations for IND/NDA is preferred.

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Contract Manufacturing Manager (NJ)
Candidate will be responsible for facilitating the transfer of information between the development and manufacturing groups and outside contract manufacturing partners. Will be responsible for: maintaining a database of current contract manufacturers and their capacities; interacting with the process development and manufacturing groups to answer process related questions; arranging teleconferences with CMO’s to facilitate the transfer of developed antibody manufacturing processes; maintaining a good working relationship with selected CMO’s; setting up meetings between company and CMO personnel; tracking the status of action items from meetings and following up on those items; maintaining a record of information transferred to and received from the CMO; obtaining general information from selected CMO’s; working with some service providers to obtain answers to company inquiries and assisting in additional tasks when needed. Up to 50% travel required. Applicants should possess a BS/BA in a science related field. Requires an understanding of mammalian cell culture, protein purification, and/or fill/finish operations in a GMP environment. Five years of manufacturing or operations technical support work in a GMP biologics facility.

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Medical Writer (CA, MA, NJ, NY, IL)
Create necessary clinical documents such as protocols, annual reports, investigators brochures, final study reports and documents for FDA. Create document templates for clinical & research use. Revise and develop SOP's regarding clinical documents. Interface with internal and external personnel and contractors. Requirements: 3-5 years of medical writing experience in a Pharmaceutical/Biotechnology environment.

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Associate Director, Biostatistics (multiple opportunities in CA, MA, NJ, NY, IL)
Associate Director, Principal Biostatistician for clinical studies, including study design, protocol writing, statistical analysis plans and reports. Work closely with medical, sales marketing and investigators to produce regulatory submissions & publications. Supervise other statistical staff. 5 plus years statistical experience in pharmaceutical or biotechnology industry. Excellent communication skills needed. MS or PhD in statistics/biostatistics.

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