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.

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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.

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Summary:

This key position within the Quality function is responsible for providing medical and scientific expertise to bring high quality and efficiency to promote patient safety for products worldwide. This position provides critical input to the clinical trials for devices in the product pipeline. This position will also be responsible for providing safety surveillance and analysis of post-market trial and product complaint data to help manage and mitigate risk.  This position requires significant collaboration with other functions outside of Quality function, including Clinical, Regulatory and Risk Management.

Responsibilities:

• Maintains timelines by providing high level medical/therapeutic guidance to internal and external customers including project teams, functional units, investigators, and regulatory agencies.
• Provides early, hands-on operational support to teams in clinical trial planning, protocol development, training of internal and external personnel, medical safety support and analysis and quality control.
• Assists in implementation of worldwide practices, policies, and processes for the global medical safety function of multiple therapeutic platforms.
• Provides therapeutic area expertise to support development and execution of clinical trials in device development process, as well as support safety surveillance of post-market trials in partnership with the Medical Sciences organization.
• Supports the Clinical organization and will assist in the creation, implementation, and harmonization of standard policies and procedures.
• Reviews and approves adverse event within the clinical trials narratives to identify any potential patient safety concerns
• Develops policies for interaction with independent study committees; ensures exchange of information with these committees is adequate to meet study timelines.
• Safety Surveillance – Provides medical support for review of product complaints and post-market trends, performs synthetic analysis and surveillance activities for marketed products across multiple therapeutic areas.
• Provides medical review and analysis of Medical Device Reports across multiple therapeutic areas; Interacts with senior level management concerning signification safety matters to provide and obtain services to support patient safety
• Actively involved in Health Hazard Assessments for events related to marketed products.
• Cross-functional interaction with Regulatory, Risk Management, Clinical Trial Medical Monitors and Clinical trial teams.

Qualifications:

• MD with in internal medicine and/or Cardiology, Cardiovascular Medicine, Electrophysiology board certification preferred
• Clinical research experience including multi-center, international trials is strongly preferred and/or a combination of patient care experience relevant to the therapeutic area.
• Managerial experience managing projects and/or professionals

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Position Overview:

• R&D compliance
• Assess quality systems, through audits and investigations of Contract Manufacturing Organization (CMOs), Contract Laboratories, raw material and component suppliers, clinical investigator sites, contract research organizations.
• Conduct on-site or paper audits and generates audit reports to qualify external supply organizations
• Maintain and follow up on corrective and preventive actions (CAPA) to ensure continuing efficacy
• Conducts PDMA compliance audits
• Highlight areas in need of improvement
• Develop and maintain master internal and external audit schedules and quality audit files.
• Collaborate and conduct investigations into root cause analysis for external supply and R&D process investigations, which include confirmed Out of Specification (“OOS”) and Out of Trend (“OOT”) results

Requirements Overview:

• A Bachelor’s degree in a technical discipline (biology or chemistry preferred but will consider other technical degrees)
• 4+ years pharmaceutical auditing experience with a minimum of one (1) year experience in clinical auditing
• 4+ years of pharmaceutical manufacturing and/or Quality Assurance experience in investigation/ root cause analysis
• Auditor certification preferred
• Familiarity with current and pending FDA regulations, 21CFR, and ICH Guidelines
• Strong knowledge of cGMP’s, cGLP’s
• GCP’s knowledge is a plus
• Knowledge of maintenance and facility systems auditing
• Familiarity with HIPAA requirements a plus
• Ability to travel extensively as the job requires 50 – 60% travel, with the possibility of up to 80% (both national and international travel required; travel will be about 40% national, and 10 –15% international)

Will offer relocation assistance

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Recruiting Director

Unique opportunity to join the senior team of a well-established and well-regarded executive search firm that also offers expanded services.

We want to speak with an experienced recruiter with a track record of success, who wants to spearhead the growth and manage a full-cycle practice, and who is finds satisfaction and is enthusiastic about each step in the process.

A background in HR practices is desirable. Commuting proximity to Northern New Jersey is required.

Annette Baron, PA, MBA

Eagle Research, Inc., Wayne, NJ

asbaron@eagleresearch.net

phone: 973-628-7700

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Position Overview:
The successful candidate will review and interpret clinical data, independently write, edit, compile and QC documents, ensure the accuracy and quality of applicable written deliverables, and ensure compliance with ethical, legal, scientific, regulatory and client standards.

Role & Responsibility:

• Review for quality and assist in the interpreting, analyzing and presenting data from clinical studies, including tables, figures and listings
• Write, review, edit and QC documents for clients including synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans, that meet scientific and regulatory standards as applicable
• Writing regulatory submissions and/or relevant sections.
• Ensure proper version control of all applicable documents
• Assist in preparing scientific, process and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings
• Resolve issues and escalate problems as necessary

Experience & Qualifications:

• BS/BA , preferably in a biomedical science plus additional medical and/or relevant scientific education.
• Advanced degree (Masters, PhD, or local equivalent) a strong plus.
• Relevant phase 1 to 2a experience in medical writing/editing, clinical drug development, clinical research and regulatory science
• Knowledge of scientific and regulatory requirements applicable to early phase clinical studies, study protocols and reports
• Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to plan/organize and multi-task.
• Excellent computer skills to include MS Word, Excel, PowerPoint, Visio; scientific graphing (e.g. SigmaPlot, Origin, Prism, Patient Profiles) a plus
• Document organization, management and version control skills to include hyper-linking, TOC generation

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Department: Medical and Regulatory Affairs
Reports to: Sr. Vice President US Medical and Regulatory Affairs

Position Summary:

• Oversight of regulatory activities supporting marketed products in US and Canada
• Supervising Associate Director of Quality Operations in the US
• Ensure efficient and compliant functioning of promotional review for marketed products, to insure all regulatory reporting requirements such as expedited safety reports, PSURs, PADERs, and REMS are completed and filed on time; also supports Phase IV studies
• Interact with Global Regulatory Affairs, North American Safety, US Medical Affairs, US Legal Affairs and Compliance and commercial functions for the purpose of providing regulatory insight during promotional plan development and implementation to ensure conformity with FDA expectations and requirements.
• Leads interactions with the FDA Office of Product and Drug Promotion and coordinating as necessary with the FDA therapeutic divisions

Essential duties and responsibilities:

• Provide expert input into promotional regulatory strategies to ensure compliance with FDA guidance’s on  advertising and promotion while meeting business needs
• Collaborate with company physicians and cross-functional project teams to design and implement high quality regulatory strategies
• Participate the development of US affiliate clinical plans to ensure protocol design, endpoint are consistent with US quality and clinical trials requirements.
• Provide strategic regulatory solutions to senior management around promotional issues
• Participate directly or through delegate in clinical sub-teams, as necessary
• Build strong relationship with FDA (OPDP) and act either individually or through a delegate as the primary FDA OPDP regulatory on matters related to advertising and promotion
• Communicate regulatory status to upper management
• Create or develop SOPs or working instructions to ensure consistent high quality regulatory affairs function
• Responsible for budgeting and other management functions as it relates to the post-marketing regulatory activities.
• Responsible for oversight of the Quality Assurance function which includes import of commercial drug, GMP audit function and product complaints
• Interact with commercial partners where applicable

Core Competencies/Knowledge & Skill Requirements:

• Experience in preparation of materials for use by Medical Affairs and experience in review/editing Promotional materials
• Poised, knowledgeable verbal scientific presenter with experience in presentations within Pharma industry and externally (medical congresses)
• Ability to interact easily with all levels within the organization; tactful; mature; flexible

Experience and Education overview:    

• Advanced and/or bachelor’s degree in a scientific discipline with years experience in the biotech/pharmaceutical industry and in regulatory affairs
• Management experience; some pharmaceutical industry managing a group
• Biologics or specialty pharmaceuticals experience, a plus
• Experience with peptides or proteins, a plus
• Experience in Endocrinology desired; experience in Neurology a plus
• Expert knowledge of regulations and drug development guidelines with some technical experience in aspects of drug development
• Solid experience with promotional review, working with Division in FDA responsible for advertising and promotion; ability to manage multiple activities or projects
• Recognized as leader, yet team player, possessing a cross-functional collaborative skill set; demonstrated ability to work in a team environment
• Ability to interact effectively across all levels of the organizations; integrates functional expertise with regulatory knowledge to solve problems, meet priorities and deadlines in alignment with US goals and objectives
• Demonstrated experience leading face-to-face and other formal interactions with senior regulatory agency representatives
• Demonstrated proficiency in departmental budgeting, organizing and planning
• Excellent oral and written communication and regulatory skills with strong attention to detail and clarity

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Essential Duties Overview:

• Provide endocrinology expertise to clinical trials in the drug and device development process
• Review and edit protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency
• Develop, plan and implement clinical research direction and vision that are in support of corporate goals and timelines
• Manage and approve the establishment of scientific methods for design and implementation of clinical protocols, data collection and final reports
• Provide clinical expertise to development project teams and assume leadership role, as appropriate, in providing clinical guidance to development, marketing and operations groups
• Provide scientific and medical expertise in support of business development activities and maintain close working relationships with R & D clinical groups, operations and marketing staff
• Provide operational support to team in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety and quality control
• Provide consistent and appropriate medical monitoring to ensure patient safety and adequate reporting and coding of adverse events in clinical trials
• Write and edit clinical reports for regulatory submission and updates consistent with medical accuracy
• Support clinical staff for review of product complaints, MDR reporting criteria, health risk assessments and product performance criteria

Overview of Requirements:

• Medical degree (M.D. or D.O.) and current license to practice medicine in Endocrinology, board certification preferred, board eligibility accepted OR demonstrated experience/expertise in metabolic drug development or R & D experience in related medical fields

• Medical degree (M.D. or D.O.) and current license to practice medicine in Endocrinology, board certification preferred, board eligibility accepted OR demonstrated experience/expertise in metabolic drug development or R & D experience in related medical fields
• Clinical experience in endocrinology including experience in the pharmaceutical industry
• Clinical research experience both outside and within the industry including multi-center trials
• Understanding of the drug development process, clinical operations, marketing principles and strategies

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Reports to:     Vice President Global Regulatory Affairs

Position Summary:

The position will contribute to the development of product registration strategies for efficient Worldwide and US registrations. Primary responsibility is to ensure alignment of the registration plans with the commercial needs and to ensure regional strategies are consistent with the Franchise and Global requirements.  The position is responsible for complex dossier development.   The position requires interaction with CMC, Quality Regulatory, Global Clinical, and other Global Regulatory Units, and commercial functions for the purpose of providing regulatory insight during plan development and implementation to ensure conformity with FDA expectations and requirements. The position is responsible for validation of registration plans through FDA meetings and other mechanisms for registration success.

The position will participate as part of the Regulatory Project Teams (RPTs), interact with the Development Project Teams (DPTs) to define the regulatory strategy and tactics consistent with the global strategy for the product,  and interact with the Global Regulatory Operations Group (GlobOps) to ensure successful registrations within the defined timelines.

Essential duties and responsibilities:

• Provide expert input into regulatory and development strategies to ensure FDA requirements and data expectations are met.
• Collaborate with company physicians and cross-functional project team to design and implement high quality regulatory strategies
• Participate the development of clinical plans to ensure protocol design, endpoint are consistent with US registration requirements.
• Serve directly or through delegate on cross-functional product development teams to ensure the risk/benefits of decisions are transparent and clearly examined.
• Provide strategic regulatory solutions to senior management and develop, employ and drive regulatory mitigation strategies to overcome development hurdles, where necessary.
• Participate directly or through delegate in product subteams, as necessary.
• Provide leadership role in the preparation and execution of dossier development through interaction with Development Project Teams and Global Regulatory Operations.
• Prepare outlines and write sections of regulatory specific documents (FDA Meeting Requests, Briefing Documents, Fast Track and Priority Review Designations, Orphan Drug Petition, Special Protocol Assessments, etc.)
• Build strong relationship with FDA and act as the primary FDA regulatory liaison for the neurology franchise in development and registration matters.
• Communicate regulatory status to upper management
• Create or develop SOPs or working instructions to ensure consistent high quality regulatory affairs function.
• Responsible for budgeting and other management functions as it relates to regulatory activities.
• Interact with development partners where applicable.

Experience and Education (minimums)

• Advanced and/or bachelor’s degree in a scientific discipline with experience in the biotech/pharmaceutical industry and in regulatory affairs.
• Experience with BLAs and/or NDAs
• Experience in endocrinology desired, but not required
• Expert knowledge of regulations and drug development guidelines with some technical experience in aspects of drug development.
• Recognized as leader, yet team player, who possesses a cross-functional collaborative skill set; ability to manage multiple activities or projects.
• Demonstrated experience leading face-to-face and other formal interactions with senior regulatory agency representatives.
• Experience with multi-national development partners.
• Demonstrated proficiency in departmental budgeting, organizing and planning.
• Demonstrated ability to work both independently and in a team environment.
• Excellent oral and written communication and regulatory skills with strong attention to detail and clarity.

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Overview:

• Responsible for providing drug safety management direction and vision in support of company objectives, goals and timelines
• Represent Drug Safety in development project teams and assume a key leadership role in providing clinical guidance for the drug safety area

Key Responsibilities:

• Provide drug safety management direction and vision in support of company objectives and timelines
• Develop, plan and implement safety surveillance and drug safety reporting
• Establish and manage the drug safety reporting process, safety review and risk management activities
• Provide clinical expertise to drug safety review both on an individual and cumulative basis
• Establish safety reporting criteria and standard formats
• Provide safety expertise to clinical trials in the drug and device development process
• Review and edit protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency
• Represent drug safety in development project teams and provide clinical guidance for the drug safety area, working closely with Regulatory Affairs, Biometrics/Data Management, Clinical Operations and additional clinical groups
• Oversee and provide appropriate and consistent medical safety review to ensure patient safety and adequate and timely reporting to regulatory agencies, IRB’s and clinical sites
• Write/edit safety sections of clinical reports for regulatory submission and update while ensuring medical accuracy
• Interface and develop relationships with Drug Safety Monitoring Boards
• Oversee and support clinical staff to ensure the highest standards for physician support to quality assurance groups for review of product complaints, MDR reporting criteria, health risk assessments and product performance criteria

Minimum Qualifications:

• Medical Degree (M.D. or D.O.) and current license to practice clinical medicine, board certification preferred, board eligibility accepted
• Minimum of 2 years clinical experience including 2 – 4 years in a drug safety/pharmacovigilance role within the pharmaceutical industry required
• Experience in Drug Safety reporting, Risk Management, Drug Safety Surveillance and in writing Integrated Safety Summaries for an approved product required
• Understanding of the drug development process, clinical operations, marketing principles and strategies

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