Overview: Support clinical study activities through study preparation and study site recruitment, initiation, performance, management, closeout, etc. Train project staff and study site investigators/coordinators and work with project teams to ensure successful clinical study completion in accordance with study timelines, investigational plan (protocol), and associated regulations (ICH/GCP) and SOPs.

Duties and Responsibilities

• Assist in preparation/design of study materials: protocols, informed consent forms, monitoring plans, case report forms, study budgets, tracking spreadsheets, other study-related forms.
• Assigned by the Study / Project Manager the following responsibilities:
• Study site initiation/set-up, ongoing study site maintenance and close-out visits; conduct routine and ad hoc monitoring visits; coordinate with CRO
• First point of contact with study site coordinators for clinical study / operations questions; interface with internal departments (e.g., Regulatory, Data Management, Quality Assurance, Technical, etc.) to ensure proper reporting and communication about conduct of study; assist with clinical operations SOP development
• Maintain regular communication with a study site Investigator and contact(s)
• Communicate monitoring report findings in a timely manner to appropriate internal staff
• Assure adequate reporting of adverse events, protocol deviations, patient status
• Identify, recommend, and implement corrective action plans in areas requiring follow-up and improvement at clinical study sites
• Coordinate shipments of study supplies
• Assure adequate patient enrollment; recommend patient recruitment plan

Knowledge and Skill Requirements

• Bachelor’s degree in a health science or healthcare degree
• Clinical research and/or study coordinator experience
• Good interpersonal and verbal and written communications skills
• Self-motivation, attention to detail and organizational skills
• Familiarity with Excel, Word and PowerPoint; strong research skills

Apply Now

Position Overview:
Senior Manager Regulatory Affairs, CMC is responsible for the definition and implementation of CMC regulatory support to global products/ projects

Support is provided through:

• Identifying, implementing, and managing CMC regulatory development strategies
• Preparing CMC filing documents (e.g. IND, CTA, NDA, MAA, ANDA, and DMF); Ensure timely delivery of CMC documents by coordinating and soliciting components of submissions from various functional areas
• Interacting with regulatory authorities and filing maintenance (e.g. amendments, supplements, and annual reports); Manage client and global regulatory authority interactions throughout development and registration
• Providing first line on-site support to the pharmaceutical technologies business; serve as liaison for co-development partners and third party customers; assemble and maintain DMFs
• Managing the lifecycle interaction with Regulatory and other departments; manage consultants and vendors
• Supporting auditing related activities globally
• Representing CMC RA as a member of the Project Team for development and/or Life Cycle Management projects; implement global regulatory strategy
• Offering strategic and operational regulatory support to manufacturing, quality assurance, project management, marketing, etc.; presenting regulatory strategy and documents
• Contributing to the department budget; identify value of the activities
• Providing Regulatory intelligence; interpret applicable regulations and guidelines
• Keeping project team abreast of regulatory decisions, issues, potential problems and new regulations

EDUCATION/EXPERIENCE:

• Bachelors Degree in Life Science, Pharmacy, or Medicine; Advanced Degree preferred; experience in the pharmaceutical industry and in regulatory activities in drug development in CMC aspects

QUALIFICATIONS:

• Communicate well in written and oral form
• Contribute/work independently within a cross-functional team
• Thrive in a dynamic and fast-paced environment
• Coordinate, prioritize, and manage multiple lifecycle projects
• Take initiative/work under minimal supervision
• Be organized and attend to details
• Perform proficiently in a Microsoft Office environment

Apply Now

Position Overview:

• Assist the Medical Monitor in communicating between clinical study site and project staff regarding protocol questions
• Assist with review and interpretation of clinical study data; writing, editing, compiling QC documents
• Ensure the accuracy and quality of applicable written deliverables, scientific and clinical research, reviews, medical monitoring deliverables
• Ensure compliance with ethical, legal, scientific, regulatory and client standards
• Assist in managing and executing daily operational and strategic activities in Clinical Research and Development

Role & Responsibility:

• Assist the Medical Monitor in communications between study site, internal project staff, and sponsors regarding protocol or other study-related questions, including documenting, tracking, following-up on all issues
• Assist the Medical Monitor in the review, analysis and interpretation of data from clinical studies, including data files, tables, figures and listings
• Assist the Medical Monitor in the writing, review, editing and QC of applicable documents, including proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, case report forms, data validation specifications, manuscripts, clinical development plans and analysis plans, ensuring that they meet scientific and regulatory standards as applicable
• Insure proper version control of all applicable documents
• Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other study-related meetings
• Assist in preparing scientific, process and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings
• Participate in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping & documentation, SOP authoring, review and revision, gap analysis and resolution of department training plans & SOPs or other procedures
• Participate and assist management in defining and managing applicable cost models, project timelines and budgets, and improve efficiencies of processes with respect to quality, cost and time
• Define, collect, track and report on metrics and KPIs
• Assist in growing and managing the CRD resource library (eRoom), including relevant literature, example documents, style guides and templates
• Resolve issues and escalate problems as necessary
• Undertake other reasonably related duties as may be assigned from time to time.
• Recognize, exemplify and adhere to company values, which are our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (10%) domestic and/or international

Experience & Qualification

• BS/BA in a biomedical science plus additional medical and/or relevant scientific education. Advanced degree (Masters, PhD, MD, or local equivalent) a strong plus
• Relevant experience in early clinical drug development, clinical pharmacology, clinical research, regulatory science and preparing applicable clinical research documentation in a pharmaceutical company and/or CRO environment.
• Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
• Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to independently plan, organize, prioritize and multi-task in a fast-paced environment.
• Excellent computer skills to include MS Word, Excel, PowerPoint, Visio; scientific graphing (e.g. SigmaPlot, Origin, Prism, Patient Profiles) a plus

Apply Now

Overview of Primary Functions:

Provide leadership to Global Safety Board

• Serve as Deputy Chair to Global Safety Board
• Oversee clinical safety team
• Coordinate and report key Board activities across portfolio
• Develop and lead a broad range of communication to a global audience related to project and program information; Develop targeted global communication materials
• Provide support on global administrative issues and outputs

Lead Risk Management

• Develop strategy, process and organizational structure
• Direct and oversee execution of Safety/Risk Management training programs;  Develop and execute strategies and programs to achieve sustainability of safety excellence training curriculum and safety physician educational curriculum
• Develop and implement global strategies, policies, procedures, for risk management activities in support of regulatory requirements
• Serve as adviser/liaison to senior management across multiple divisions in order to plan, evaluate and recommend risk management activities
• Support business partner relationships to ensure integration of Safety/Risk Management activities across the organization
• May serve as spokesperson to regulatory agencies on drug safety issues

Clinical Safety function

• Provide leadership and oversight
• Serve as expert resource and first point of contact for clinical safety and safety board; determine urgency, strategy, and accountability; develop and guide effective communication strategies

Supervisory or Managerial Responsibility:

• Lead multiple global cross- functional teams
• Supervise direct reports

Education/Experience Qualifications:

• MD, DO or equivalent medical degree
• Clinical practice and global clinical trials phase I-IV; pharmaceutical medicine; drug safety, regulatory affairs and/or legal implications experience
• Experience in risk management planning and execution
• Broad project management experience;  experience leading matrix, cross functional teams in safety or other development related activities
• Experience interacting independently with senior management on strategic and confidential issues that have potential business impacts

Apply Now

Position Summary:
The Senior Manager will play a pivotal role in the development of the Clinical Trial Quality and Compliance function within the Clinical Operations department.  The Senior Manager will assist with the development, implementation and maintenance of a proactive GCP compliance management system, including the development of processes and standards, training, and ensuring that regulatory requirements (ICH, FDA, EMA, etc.) and guidelines are adhered to.  This individual will also be involved in developing a GCP inspection readiness program and will serve as a GCP compliance expert to the CDMA organization.

Key Responsibilities:

• Assist with development, implementation and maintenance of a robust GCP quality management system, including development of policies and procedures related to clinical research conduct
• Lead the development of internal process improvements related to GCP compliance, including implementation of an effective and compliant GCP CAPA management process
• Develop and deliver GCP and other relevant training to clinical research staff
• Work with relevant internal functions to develop a GCP inspection readiness program; Liaise with R&D Quality Assurance to support audit and inspection activities; Assist with inspection activities (preparation, conduct, and responses) for GCP inspections at company and investigator sites
• Serve as subject matter expert concerning GCP and provide compliance guidance to internal clinical research personnel; May mentor and manage junior staff, contractors, and consultants
• Proactively monitor and assess compliance risks within and across studies; collaborate to address identified compliance risks and promote a state of inspection readiness
• Perform quality control  reviews of key clinical documents; Conduct ongoing quality control assessments of departmental activities and processes to ensure they remain relevant and current

Qualifications Overview:

• Bachelors degree required; Master’s degree preferred
• Experience in Clinical Compliance, Clinical Research Monitoring, Clinical Trial Management, and/or , Clinical Quality Assurance within the pharmaceutical/biotech industry ; Proactive approach to GCP compliance
• Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines; Understanding of the clinical development process and documentation requirements
• Knowledge of outsourced models of clinical research conduct and associated sponsor requirements
• Knowledge of site and vendor auditing processes and recent FDA and EMA inspection findings
• Ability to work independently with minimal direction
• Desired: Experience building GCP quality systems, including development of SOPs, effective CAPA programs, and development/delivery of GCP-related training, Experience managing direct reports and contractors/consultants

Apply Now

Position Overview:

• Responsible for managing and mentoring medical writing staff and external business consultants with a variety of writing responsibilities to achieve objectives and goals.
• Review writing assignments and daily activities of in-house and contract medical writers and train staff on documentation preparation
• Prepare Phase I – IV clinical and regulatory documents and submissions, such as investigator brochures, clinical study reports, integrated summaries of safety and efficacy, registration dossiers, package inserts and responses to health authorities
• Develop strategy for document preparation, including time frames
• Prepare internal guidelines for document preparation, prepare templates for clinical documents consistent with ICH and FDA guidelines as well as electronic submissions
• Participate in developing outsourcing plans for Medical Writing and manage outsourcing writing projects when appropriate
• Develop, implement and manage a Medical Writing operational plan consistent with the overall objectives of the Medical Affairs Group
• Assist with preparation of presentations for major external meetings
• Assist with transferring and presenting clinical/regulatory data to Marketing for journal submissions and draft SOP’s as needed.

Qualifications Overview:

• Master Degree, PhD. or PharmD preferred with applied work experience; with some years experience in the pharmaceutical industry
• Regulatory writing experience, ISS and ISE experience, managerial experience

Apply Now

The Director, Project Management is accountable for:

• Actively leading internal cross-functional teams locally to ensure the effective delivery of project milestones
• Responsible for the management of COMBO product development through NDA approval and product launch
• Working closely with the Senior Vice President, clinical investigators, functional heads and senior staff of Marketing, Sales, Operations, Finance, Regulatory Affairs etc, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.

Duties & Responsibilities:

• Provide on going support for departmental or organizational initiatives; serve as a back up to the Senior Vice President
• Accountable for managing project timelines and deliverables; evaluate and communicate the probability and impact of risks, develop quality and risk management plans for performance and ensure integration into the overall plan for the monitoring management project deliverables in accordance with project plan
• Manage COMBO product development activities, facilitate adherence to timelines and manage functional area expectations in order to assure timely completion and NDA filings; monitor program progress and identify potential bottlenecks; set meeting agendas and communicate with senior management
• Responsible for managing R&D budget planning process with Finance.
• Assess project risks, and recommend contingency plans and strategies to mitigate regulatory risks.

Qualifications:

• Minimum of a Bachelors’ degree. Advanced degree preferred.
• Significant project/ program team management experience within pharmaceutical and/or healthcare setting.
• Demonstrated analytical, negotiation, meeting management, cross-functional team, leadership, and managerial skills

Apply Now

Overview:

• Position focus is on the development and post-approval of medical devices and combination products in sequence with drug delivery.

Responsibilities include:

• Contribute to the development and implementation of CMC device regulatory strategy; Identify and assess regulatory risks
• Serve as the regulatory representative on project teams, making key project related decisions for post-marketing and/or development programs
• Serve as liaison to internal operations groups, development personnel and manufacturing partners
• Serve as regulatory contact with relevant regulatory authorities, and coordinating device CMC aspects of regulatory submissions
• Manage the regulatory submission process through to approval, including management and coordination of the preparation of regulatory documentation
• Provide critical review of regulatory submissions to ensure accuracy, adequacy, consistency and conformance to regulatory requirements and proper language

Requirements include:

• Regulatory experience for medical devices and combination products
• Familiarity with Medical Device regulations, Good Manufacturing practices and a record of successful submission strategies for combination products
• BA/BS/University degree required, Life/Health Sciences preferred.

Additionally, the candidate should have:

• Demonstrate excellent communication and influencing skills internally and externally
• Demonstrate effective cross-functional and cross cultural skills, strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
• Ability to apply analytical and creative thinking problem solving
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.

Apply Now

Position Report to:     Director, Regulatory Affairs

Job Description:

• Assist in the review of pre-approval and post-approval submissions from internal team in accordance with current regulations from US FDA and Health Canada, as needed. Review includes a detailed scientific/regulatory review ensuring compliance to all appropriate regulations. Communicate significant and/or potential issues.
• Provide strategic regulatory advice on pre-ANDA activities; specifically, providing clarity to inactive ingredient database controlled correspondences, bioequivalence recommendations, and meeting requests for NDA 505(b)(2)s.
• Actively participate in business development meetings providing updates on approval/launch status; work with regulatory bodies to ensure appropriate follow-ups, coordinate with IP on patent/exclusivity status, and ensure immediate items such as PLAIR requests, drug listings, import shipment clearances and labeling are completed.
• Independently review and provide feedback to the promotional review committee related to promotional marketing items.
• Assess and justify the appropriate category for post-approval change classifications. Also, assist the R&D teams in approach strategy in accordance with compliance requirements.
• Act as primary point of contact for internal stakeholders with most recent FDA communications; working with Regulatory Operations staff to ensure timely archiving and tracking of all external communications.
• Support internal functional groups (i.e., Marketing, Sales, IP, Legal, QA and Pharmacovigilance) with information requests related to submissions, customer queries, labeling changes, etc.
• Participate as the regulatory representative on US-based R&D teams in assisting with regulatory strategy such as stability requirements, packaging requirements, bioequivalence guidance, labeling requirements, and generics including potential NDA 505(b)(2) submissions.
• Provide guidance, advice and training to junior staff members; supervise, as needed
• Support eCTD, SPL and electronic submission gateway/upgrades.
• Provide assessments for regulatory impact relating to Change Controls, Deviations and Corrective Actions.
• Some international travel required.

Requirements Overview:

• Bachelor’s degree in scientific field mandatory. Advanced degree (M.S.) preferred.
• Experience working in Regulatory Affairs supporting US FDA requirements.
• Regulatory knowledge of various dosage forms (i.e. solid oral, semi-solid, extended release, OTC, injectables, topical patches) preferred.
• Exceptional organization abilities; ability to track approval status for a large number of products
• Excellent verbal and written communication skills
• Prior experience working with generics strongly preferred.
• Knowledge of Health Canada requirements preferred.
• RAC preferred.

Apply Now

Position Overview:

The Senior Manager, Drug Safety is responsible for managing a team of Safety Associates.  This includes development and implementation of processes necessary for day-to-day operations, as well as the appropriate monitoring of the safety of the company’s marketed products through pharmacovigilance activities including the intake, evaluation, processing, and follow-up of adverse event reports.  The Senior Manager is also responsible for managing staff working on specialized case-related projects and functions.

Additional responsibilities will include:

• Ensuring appropriate resolution of any legal liability issues, and complying with government regulations.
• Ensuring complete and accurate maintenance and reporting of Adverse Drug Experiences (ADE) and Adverse Drug Reactions (ADR) data to regulatory authorities, ethics committees and other bodies as required by regulations.

• The Senior Manager, Drug Safety also leads the development and implementation of appropriate processes for the Global Case Management team and ensures adequate training of relevant parties.  This individual will lead cross-functional teams and projects across the global case management function to ensure consistency and harmonization across the team.  Also, represents the safety group on cross-functional teams and serve as a resource for the department with regard to safety surveillance business processes.

Overview of Required Education and Experience:

• Experience in a clinical setting
• Experience in a Drug Safety department in pharmaceutical/biopharmaceutical industry.
• Supervisory/ direct line management required
• Minimum of Bachelor’s level degree in nursing, pharmacy, or other health related profession.

Apply Now