PHARMACEUTICAL and BIOTECH

J. Edgar and Associates Inc. is an industry Leader in Scientific, Clinical and Operations Recruitment at all Levels. If you are currently in the Market for a new employment opportunity, we invite you to view the current opportunities below.

Check frequently for the latest hot jobs...IT Manager, UNIX, WIndows, WEB...Clinical Project Manager...Process Engineering Manager...Sr. Bilingual CRA...Sr. CRA, Toronto...HRManager/Talent Acquisition...Clinical Data Manager...Principal Biostat...Manager Clinical Supplies...Sr. Manager R.A...Principal Biostat, USA


IT MANAGER, UNIX, WINDOWS, AND WEB TECHNOLOGIES, GTA TO $120K PLUS 10% BONUS

We are currently seeking a capable, service oriented, flexible, IT Project Manager for our client in the clinical research sector to manage, administer, implement and maintain Network and Systems Administration including Web technologies with a focus on deliverables. This position is comprised of Project Management and Technical Writing including technical SOP documentation and will provide oversight in the operation of business critical applications such as iDataFax, SAS, IWRS, InForm/CentralDesigner , FTP Servers, eCTD Manager, Oracle DBs, MS Exchange Server, Sharepoint and Web Portals. The Manager will also provide oversight in the Management of network security systems while monitoring system and network performance and applying corrective and preventative measures to ensure optimal performance and minimal downtime. Join a high performance team of 4 technical IT specialists creating new unified communications. Work with like minded professionals on mission critical IT projects utilizing your customer interface specialty and realize your full potential.

This particular IT Project Manager will provide oversight to system and security monitoring system and application log reviews, server resource report reviews and weekly reporting of any errors, warning or report output which require further investigation. Audit experience is an asset! This position will provide 7/24 on call rotation support of business critical applications and supporting infrastructure while developing and maintaining system and infrastructure documentation as well as training IT staff in the use of software, hardware and technical controls. Part of your technical repertoire should include: System validation, disaster recovery, serve upgrades, IT infrastructure, and a service oriented approach.

You must have experience with: Systems Validation Project Management and Writing Documentation deliverables. Also, 5-6 years Unix (Solaris) and Windows Server Systems Administration, 5-6 years Checkpoint Firewall Admin., Strength in Active Directory, Business Continuity and Disaster Recovery success, Oracle DB administration, App Server Admin: Oracle Java System Web Server, Tomcat 6/7, Experience with VMware and VEEAM Admin. experience. Overall, you must have excellent verbal and written communication skills and present professionally in a highly regulated environment working on critical applications that have impactful ramifications for the diverse populations.

We are seeking at least 10 years of successful IT Management experience and a collaborative personality. Pharmaceutical and Clinical Research environment experience will be beneficial and be an asset but not a requirement. Training will be provided.

Salary: $100-$120K, Bonus: 10%, plus RRSP contributions, full and comprehensive health benefits and much more. Location: GTA.

Please call Cris Murray at 416 225-6386 to find out more details. Email resume in Word format to: jedgar@sympatico.ca


CLINICAL PROJECT MANAGER TO $85K PLUS 10% BONUS, GTA OFFICE BASED

We are seeking a Clinical Project Manager to drive continued success in this exciting clinical research field as we are seeking committed, skilled, and customer-focused individuals to join our clients winning team as a Clinical Project Manager (focused on Biometric Project Management) for our Toronto/Markham, Ontario, Canada location.

Key Responsibilities:

The incumbent is responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to our clients internal management and its clients. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.

When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.

When required, the incumbent may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.

  1. Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.
  2. Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
  3. Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
  4. Be the primary point-of-contact for clinical trial sponsors to ensure the timely initiation and completion of clinical projects.
  5. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
  6. Coordinate activities between our client and trial sponsors, and with various supporting groups or third party vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met.
  7. Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
  8. Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
  9. Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
  10. Function as meeting facilitator for the meetings involving various internal and external participants.
  11. Function as facilitator of problem solving and conflict resolution.
  12. Communicate project action items and key decisions through timely minutes and follow up actions.
  13. Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
  14. Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
  15. When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities. Attend and present at bid defense meetings.
  16. When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
  17. May provide support in Clinical Operations as required, such as the following:
    - Assist in the development of study-specific training materials.
    - Manage the process of setting up and maintaining the Trial Master File.
    - Review/compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.
    - Assist with the preparation and negotiation of contracts with vendors and investigational sites.

Qualifications and Experience:

  1. B.Sc. or M.Sc. in life sciences or health related field.
  2. Minimum of 8 years’ clinical research experience within a pharmaceutical, biotechnology, or CRO setting.
  3. Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
  4. Ability to travel a maximum of 30% of working hours may be required.
  5. Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
  6. Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
  7. Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
  8. Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
  9. Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
  10. Strong ability in problem-solving including conflict resolution.
  11. Fluency in French, including medical and scientific terminology, will be desirable.

Salary: $80-$85K plus 10% bonus, vacation and comprehensive Health care benefits.

Please call Cris Murray at 416 225-6386 to find out more details. Email resume in Word format to: jedgar@sympatico.ca


PROCESS AND MECHANICAL ENGINEERING MANAGER - GMP MANUFACTURING TO 120K, GTA

We are currently seeking an Engineering Manager with at least 7 years of experience and a P.Eng designation to lead the Process and Mechanical aspects of a very productive cGMP environment. This position manages an experienced group of Process Engineers and their Support personnel in resource planning and scheduling for multiple production lines in Pharmaceutical production.   This role will interface with Maintenance, Production Operations, PDS, Commercial and Quality in order to execute equipment, process, product and system's installation, qualification and validation.

Managing and ensuring that all cGMP, Health and Safety, Environment compliance standards are in place and adhered to including up to date processes, SOPs, KPIs, documentation and training are key aspects in this position. As EM, you will also assist in setting engineering project completion dates that align with production, short and long term facility plans and assisting in developing the Engineering capital and operating budget. As EM, you will define, document and implement engineering standards for drawings, specifications, documentation control, software, manuals, test procedures, revision control and configuration.  These items and standards are in place and require update and maintenance as required.

Managing equipment and facility capital projects related to equipment installation or re-location is part of this very focused planning role, this position interfaces with Facilities management regularly. This position oversees the selection, identification and management of contractors and capital projects. This role also works closely with Compliance to provide updates to the Master Validation Plan while overseeing the preparation of protocols/documents for equipment, process and system's qualification/validation.  This position works with Operations Management to lead continuous improvements in terms of design engineering efficiencies, process, quality, safety and problem resolution in compliance with cGMPs. Operational excellence within the Engineering team is a mandate.

You should have at least 7 years of experience in a Pharmaceutical production and Packaging cGMP environment with an Engineering degree in Mechanical or Chemical and a P.Eng designation. You should have a strong understanding of Global Manufacturing Compliance and Technical Standards. Strong MS Project, Visio and AutoCAD skills are essential.

Salary - $110-120K - 3 weeks of  Vacation - Christmas Shut Down - 7 Personal Days

Please call Jason Edgar at 416 225-2628 for all the details. Resumes to - careers@jedgarcareers.com


SENIOR BILINGUAL CLINICAL RESEARCH ASSOCIATE TO $115K, PLUS 10% bonus, CAR ALLOWANCE, FULL BENEFITS. 70% Travel, Work from Home, Quebec, Montreal or Ottawa based.

Our client, specializing in Clinical operations is searching for a Senior Bilingual Clinical Research Associate where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials. Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's and ability to travel to local study sites up to 70%.

Salary: $100-115K.

Bonus: 10% annual bonus, car allowance and other relevant expenses plus full health benefits package, RRSP contribution and 4 weeks paid vacation.

Please call Cris Murray 416 225-6386 at J. Edgar and Associates Inc. to find out more information about this exciting new opportunity.

Please email your CV in a word format to me directly: jedgar@sympatico.ca


SENIOR IN-HOUSE CLINICAL RESEARCH ASSOCIATE TO $115K, PLUS 10% bonus, FULL BENEFITS, 4 Weeks vacation, RRSP matching contribution, GTA

Our client, specializing in Clinical operations is searching for a Senior Clinical Research Associate where you will be responsible for monitoring, reporting, tracking study progress, and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study-specific plans, and Standard Operating Procedures. 

The role includes leadership of the Clinical Operations study team as well as assessment and direction of other Clinical Operations staff assigned to studies.  We are looking for an interactive team player who knows how to work with study sponsors, investigational sites and vendors to enable timely and high quality initiations and completions of Clinical Trials. Our client needs your ability to identify, evaluate and qualify investigators and investigational sites for participation in clinical trials.

Your ability to compile documentation for qualification of clinical sites and ensure they are compliant with ICH-GCP and relevant local regulatory bodies will enable your success in this newly created role.

Bring your keen sense of contract negotiations to collectively participate in and prepare presentations for clinical trials initiation meetings and or training sessions.  Perform on-site monitoring of clinical studies and document monitoring activities through submission of monitoring reports to Clinical Operations management for review.  Responsible for site management.

Requirements: Bachelors degree in Life Sciences or Health related field.  Minimum of 5 years of experience in monitoring clinical trials in the field required.  Excellent written and oral presentation skills, thorough knowledge of GCP's.

Salary: $100-$115K.

Bonus: 10% annual bonus, relevant expenses plus full health benefits package, RRSP matching, a monthly Fitness expense and 4 weeks paid vacation.

Please call Cris Murray 416 225-6386 at J. Edgar and Associates Inc. to find out more information about this exciting new opportunity.

Please email your CV in a word format to me directly: jedgar@sympatico.ca


 HUMAN RESOURCE BUSINESS PARTNER / TALENT ACQUISITION SPECIALIST TO 80K PLUS 10% BONUS, NORTH GTA

We are currently seeking a Human Resource Business Partner - Talent Acquisition Specialist for a very successful and growing Canadian firm, based in Toronto with two global locations.  We are looking for an individual who can deliver full cycle recruitment strategies in a scientific and technical setting.  Your proven success in streamlining internal selection and interviewing processes from a pool of qualified Technical specialists is being called upon. 

As Talent Acquisition Specialist, you will identify and qualify 'specialized' candidates while facilitating and coordinating the introduction of Candidates to internal Hiring Teams and process the outcomes.

You should be well versed in recruitment best practices including clear communications, both verbal and written, to internal Hiring Managers (HMs), External Search Partners (ESPs) and Qualified Candidates(QCs). Your strengths in follow up and next step process initiatives are crucial in this role.  

As a Scientific Services company in a highly competitive market, timing is the greatest factor in the recruitment, interviewing and hiring of Qualified Candidates. In this role, it is essential to maintain up to speed correspondence on next steps with HMs and ESPs.  Existing Recruitment Service Agreements create a constant influx of Qualified Candidates who require immediate attention in order to deliver next step interview processes.  The competitive nature of the industry dictates a need for immediate QC response time and efficient interview processes. 

Qualifications include: A University degree, CHRP is an asset. Strong communication skills both written and verbal . Proven success in Interview process initiatives: Follow Up, Circle Back and Reach Out functions in order to move hiring processes to positive outcomes is required.

Location: North Central GTA

Salary: to $80K plus full benefits, RRSP matching contributions, Gym membership, tons of perks!

Bonus: 10% annual bonus.

Call Cris at 416 225-6386 for all the details. Please send your CV directly: jedgar@sympatico.ca


 2 CLINICAL DATA MANAGERS, INTERMEDIATE AND SENIOR TO $95K PLUS 10% BONUS, GTA or Work From Home if you live outside Toronto

We are seeking 2 CDM's  in total.  The Clinical Data Manager's will lead assigned data management projects by applying project management skills and data management techniques to ensure timely and quality deliverables. The incumbents will manage project timelines and coordinate activities for assigned projects, and be responsible for the development of Data Management Plans, clinical trial case report forms, databases, and overseeing data processing.

A bachelors' degree in health science, registered nurse, or higher equivalent education in relevant disciplines, with a minimum of 2-5 years experience in clinical trial data management, and demonstrated leadership ability to effectively manage clinical trial data management activities and integrate them with the entire clinical trial operations; must communicate effectively, orally and in writing. Experience with clinical trial electronic data capture systems and in particular must have experience using MediData Rave. Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is required. In addition, the incumbent must have excellent oral and written communication skills and to apply such skills in logical and algebraic operations.
 
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our clients winning team as a Clinical Data Manager.

key accountabilities are:  Plan, manage, control and performs data processing and management activities for assigned projects.  These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements.   Lead assigned data processing and management projects by applying project management skills, data processing and management techniques. Manages timelines and coordinates activities for assigned projects.  Specify database validation checks for assigned studies.  Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.  Define and monitor clinical trial dataflow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and quality control processes.  Design and review patient Case Report Forms and database schema.  Test data capture/entry screens.  Accurately and efficiently validate electronically captured data.  Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.  Lead efforts in building a standard query library for common database modules as well as for therapeutic/drug area specific modules.  Perform quality control procedures on assigned database during the trial, and additional database closure checks at the end of the study.  Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling and management of trial data.  Validate and distribute study progress status reports to internal and external study team members.  Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures and medications.  Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.   Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial Case Report Forms (CRFs), database schema and databases for assigned studies.

Salary - $70-$95K plus bonus and full health benefits. Start: ASAP.

Please call Cris Murray 416 225-6386 for all the details.

Please send your resume in confidence to : jedgar@sympatico.ca


PRINCIPAL BIOSTATISTICIAN  WITH MSc. OR Ph.D. TO $115K, TORONTO, OR WFH OUTSIDE OF TORONTO PLUS 10% BONUS

Our client has opened a third international location in Shanghai and we are searching for several senior talented Biostatisticians who will be accountable for developing, applying and/or providing expertise in clinical trial statistical and programming methods and techniques to effectively manage and complete statistical and programming projects, and to support the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and programming team activities for clinical trials from the development of study protocols to the completion of study reports. May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

  1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others. 
  2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but not limited to, the following:
    - Providing leadership/expertise in research and development of statistical methodologies.
    -  Investigating and implementing new technologies, processes and procedures.
    - Developing and executing customer relationship management plans.
    - Participating in new business development and bidding processes.
  3. Act as Lead Biostatistician/Teammate Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
  4. Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables.
  5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
  6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
  7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
  8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications. 
  9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
  10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
  11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
  12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
  13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
  14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
  15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
  16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
  17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
  18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
  19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
  20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
  21. Plan and carry out professional development.  

Qualifications and Experience:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related plus 7 years of relevant experience or a Master’s degree plus 10 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

If you are interested in confidentially exploring this opportunity, kindly send your resume to me directly at:  jedgar@sympatico.ca, 416 225-6386


MANAGER CLINICAL SUPPLIES/ NEW PRODUCT R+D $170K plus Bonus, USA

We are currently seeking a Manager for Clinical Supply in the early research and development phases of New Drug development.  This position will work closely with Formulations and Materials Management groups, Statisticians, Clinical Research and Data Management teams and other Clinical, Global Drug Safety, Regulatory and Project Management staff to supply Clinical Trial Materials for Clinical Studies.

The Manager will oversee and contribute to the completion of all technical and operational activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources. As Manager, you will deal with complex processes across functions and interact with clinical protocol teams including Biostatisticians and Clinicians, Materials Management, QA, formulation and process development and regulatory affairs groups to provide input into the packaging and labeling strategy.

As Manager, the incumbent will oversee a Team of 5-6 reports tasked with planning, implementing and initiating activities on multiple projects related to the labeling and distribution of clinical supplies to ensure clinical supply study start dates are met. Working closely with Clinical, Formulations and Materials management teams to forecast drug supply needs for clinical studies and Managing labeling contractor activities including Contractor selection is a major aspect of this role. As Manager, you will manage the labeling and distribution budget for each related project and be able to write and review SOPs required for labeling and distribution as well as write and review packaging and labeling batch records and label artwork.

Managing external vendor relationships and negotiating contracts while conducting vendor audits with QA is another aspect of this role. You should be able to perform PPS, IQS, RCVS, EQMS and EBS transactions while preparing and approving purchase orders for specific programs.  This position is tasked with management of Clinical Supply inventory at CMO facilities including movement of Clinical Supplies, monitoring inventory levels, resolving issues and working with QA to resolve quality issues with labeling vendors and clinical supply partners.

You must have BS in Pharmacy or a related Scientific field with a minimum of 6-8 years of relevant experience. You must possess a strong knowledge of the FDA, cGMP and GCP standards as well as Regulatory guidance documents such as Annex 13.

 Salary - $150-170K Bonus - 15-20%, Generous Company Incentives - Executive Class Relocation Program

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


 

SENIOR MANAGER REGULATORY AFFAIRS, CMC TO $160K, US WEST COAST

We are currently seeking a Senior Manager for Regulatory Affairs responsible for preparing and reviewing technically complex regulatory CMC submissions. This position requires extensive interaction with departments within and outside of Pharmaceutical Development and Manufacturing (PDM) for preparing regulatory documents while meeting aggressive timelines. As Sr. Manager you will ensure regulatory submissions are in line with regulatory requirements and company policies and procedures. Timing is key for these amendments to submissions  using sound scientific justification is employed in CMC regulatory strategy. The Senior Manager will be called upon to provides strategic regulatory advice as appropriate.

Your expertise lies in creating and reviewing change controls and controlled documents to support post-approval changes. The incumbent must ensure that information in the change controls and controlled documents are accurate and scientifically sound.  As Sr. Manager you will manage and deliver change controls to ensure the initiation and implementation of change in a timely and effective manner. 

You must have a BS degree in a relevant discipline and a minimum 8-10 years of relevant experience in Regulatory Affairs. An advanced degree is desirable and an asset.  In this role, it is essential to be a detail-oriented, self-motivated, and organized professional, with excellent verbal and written communication skills and interpersonal skills.

The Senior Manager must have experience with authoring and thoroughly reviewing regulatory/quality CMC documentation for accuracy and conformance to regulatory/quality requirements. Knowledge of regulatory/quality CMC related requirements is a must. You must be able to work independently with minimal direction. Previous people management experience is required. 

Salary - $150-160K plus 18% Bonus, Location - US West Coast, Start - By the end of 2017, Relocation - Thorough and Generous

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


SENIOR MANAGER-RESEARCH SCIENTIST- NDAs -TO $150K PLUS 20% BONUS, US WEST COAST

We are currently seeking an experienced Research Scientist to manage and support methods validation for late stage development and commercial products.  Experience with Methods transfer is essential as this position will be working directly with long distance internal customers, contract manufacturers and external vendors.  The incumbent must be able to manage multiple projects and participate in or lead cross functional project teams.

The role requires expertise in the highest level of analytical support while meeting timelines and ensuring compliance to SOPs, protocols, cGMPs and safety regulations.  The incumbent will support global regulatory filings with methods validation and methods transfer.

In this role, you will direct and execute scientific research for the development of drug candidates or the research support for marketed drugs while investigating the feasibility of applying advanced principles and techniques of related scientific specialty to products and problems.  Your expertise lies in your ability to utilize state- of- the- art techniques to characterize substances, assays and tools.  You must be able to exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results while being able to recognize anomalous and inconsistent results and interpret experimental outcomes.

In order to achieve success in this role, you should have; a PhD in Chemistry or Equivalent in a related science.  We are looking for someone who has been a lead Investigator on a commercial product ideally or someone who has led a team of Analytical research scientists at different stages of new drug development.  Your ability to manage projects and cross functional team players while overseeing method transfer to contract manufacturers is very important for this role.  You should be expert in LIMS, EmPower, Trackwise, UHPLC and current analytical methods for development and validation.  You must be up to date with USP/ICH/FDA common practices and compliance.

Salary to $150K plus 20% bonus

Relocation is thorough and complete including Temporary housing.

Call Jason Edgar for all the details at 416 225-2628, resumes in Word format careers@jedgarcareers.com


 PRINCIPAL OR SENIOR BIOSTATISTICIAN WITH MSc. OR Ph.D. TO $170K, NEW JERSEY OR TELECOMMUTE

Five years experience in clinical drug trials (Phase I to Phase IV) or 5 years developing SAS datasets (R is an asset) is required along with the ability to meet with a variety of stakeholders to assess and understand their statistical needs. Above all, an ability to communicate complex details in a concise manner is required.

Your responsibilities include: protocol development, clinical study design, writing ICH reports, medical writing, manuscript preparation, development of statistical analysis plans, consulting in bio-statistics, study design, regulatory issues, interviewing and selecting new biostatisticians as well as SAS programmers and reviewing SOP’s

Educational and Experience:
Ph.D. or MSc. with significant experience in Statistics/Biostatistics
5 years experience in clinical drug development in a pharma/biotech, CRO or academic environment
Protocol and Clinical Study design
Clinical data management
SAS programming R programming, Matlab, LaTex
Clinical research report writing
Exposure to many therapeutic areas including Cardiovascular, Oncology, Endocrinology, CNS, Women's and Men's Health, ID etc...
Experience in the analysis and reporting of Phase I-IV clinical trials
Advanced communication skills written and oral
Excellent interpersonal skills
Flexible and comfortable with tight and changing timelines
Knowledgeable with ICH, FDA, EMEA and TPD guidelines and regulatory issues

Salary - $155-$170K, 3 week vacation, New Jersey or telecommute

Please send your resume in confidence to : jedgar@sympatico.ca


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