Montréal (Quebec)
Canada

EMPLOYMENT STATUS
 Regular - Full Time

POSITION SUMMARY
 Responsible for conducting scientific evaluation and prepare written
document in supporting to company pipeline project selection committee as
well as decision of in-license product selection. Prepare scientific
document in responding to the queries from regulatory agencies, business
partner and other departments of the company. Provide suggestions and
judgment in the study design on the product in complicated nature. Make
literature search and prepare necessary technical document. Establish study
design and making recommendation related to study design and study
requirements based on TPD/EU/FDA guidelines. Update of Bio-study regulatory
requirements for HPFB/EU/FDA.

EDUCATION
 Master's degree or Ph.D. in Pharmacology, Pharmacokinetics or related
field.

EXPERIENCE
 Minimum of five (5) years of experience in biopharmaceutics.

OTHER
 Good planning and oranizational skills, meticulous, responsible and
self-motivated, knowledge of Good Clinical Practices (GCP), excellent
knowledge of pharmacokinetics, good understanding of government
bio-equivalence requirements.

IMMEDIATE SUPERVISOR
 Biopharmaceutics and Clinical Research Director

Responsibilities:

As a computer validation specialist, the candidate must be able to work independently, and apply experiences and guidance to solve client issues. The candidate will be required to develop plans and protocols, create/review SOPs, create/review system specifications, and assess systems for Part 11 compliance.

Qualifications

Candidates must:
- have a university degree in computer science, computer engineering, sciences or any other pertinent degree;
- have 5 years of experience in the pharmaceutical or biotechnological field, with at least 2 – 3 years specifically in computer validation;
- be familiar with the FDA, Canadian and European compliance regulations with regard to computer validation and GAMP;
- have in-depth knowledge of GMP standards and protocol writing (IQ, OQ, PQ)
- experience in retrospective validation;
- familiarity with the development of Validation Plans, URS, FS and Design documentation;
- experience in validation of some the following systems: LIMS, ERP, Document Management Systems, spreadsheet/database applications, SCADA;
- experience in Part 11 assessments and remediation activities;
- experience in programming and database administration, from an IT perspective, is an asset;
- experience in Laboratory equipment and processes is an asset;
- have excellent verbal and written communication skills, especially where report writing is concerned;
- be willing to travel;
- possess strong analytical skills;
- promote team spirit;
- have strong decision making skills and be dynamic;

A competitive compensation and benefits package in a fast-paced work environment. We are looking for innovative, forward-thinking people who enjoy challenge and actively seek to develop and improve work processes.

Key Responsibilities:

• Contribute in proactively formulating analytical strategies that successfully execute our core business of pharmaceutical development.
• Participate in clinical and preclinical study designs and protocols, specifically coordinating, facilitating and constructing appropriate statistical analysis plans and CRFs to support the development plan and are consistent with the requirements for regulatory filings
• Maintain expertise in state-of-the-art data manipulation and statistical analyses.
• Develop statistical methodology for studies, including sample size calculations, randomization schemes and strategy, and analysis plan
• Evaluate databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.
• Implementation of protocol methodology and statistical plan to assure timely and accurate, complete and consistent analyses
• Directly or indirectly deliver appropriate, accurate and understandable line listings and statistical tables, and preparation and review of statistical sections of study reports and submission reviews
  Use validated SAS macros, write SAS code, develops program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis output
• Contribute to development of timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with ourobjectives.
• Supervise review of CRFs to issue queries and clean data as required and direct database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs and ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs
• Develop, interact with, and manage internal employees and external CROs to assure timely and GxP compliant activities to achieve project successes to achieve corporate development plans
• Participate in regulatory submission process, including INDs, CTAs, CTDs, NDAs, serve as statistical interface with the FDA for regulatory submissions and approvals and provide appropriate biostatistical updates to those documents
• Ensure that all documents to be submitted to regulatory agencies are complete, statistically accurate, well-organized and of high quality in such a way as to facilitate review
• Build and maintain good business and working relationships with internal and external groups
• Serves as the statistical contact with outside investigators for participation in advisory boards, in the preparation of scientific presentations and manuscripts and takes a leadership role in process improvement, training, standards development or an area of technical expertise
• Participate in analysis and review of data, and review, edit and contribute to the construction of clinical documents (study reports, publications and summaries) to ensure cGCP compliance and accurate presentation of data
• Provide strategic leadership to identify potential difficulties and strategic execution to implement creative approaches to surmount challenges
• Participate in activities related to potential inlicensing and outlicensing of products
• Mentor and manage activities of statisticians and nonstatistical peers, and provide positive environment to motivate less experienced personnel and communicate statistical concepts to scientists and nonscientists

Requirements:

• MS or PhD in Biostatistics or Statistics or related field
• 3-5 years pharmaceutical industry clinical development experience including support of product approvals and renewals, experience with clinical data management systems would be useful
• In-depth experience with strategic clinical trial planning and analyses that include experimental design, SAS programming, statistical writing and data analysis methodology, biometrics and descriptive and differential statistics that are applicable to meet FDA and ICH guidelines, as well as AMA Style, CONSORT and GPP publication guidelines
• Ability to work independently and as a functional leader and participant in teams
• Approximately 5% travel

Reporting to Manager, Clinical Affairs, the CTM will be able to independently organize and manage multiple tasks related to clinical studies of varying type and complexity; while simultaneously ensuring study milestones are met and completed according to the protocol, regulatory requirements and Cytochroma standard operating procedures. The CTM directly interfaces with data management and biostatistics, field clinical monitors, medical directors, and acts as a primary liaison with investigators and clinical site staff.
Note: this is an in house position, thus minimal Travel.

Responsibilities:

• Participates in the design and planning of clinical research projects.
• Generates clinical study plan including timeline projection and monitoring strategy and schedule.
• Directly oversees vendor (s) and study team on assigned studies to ensure consistency of methods, interpretation and approach of assigned studies
• Oversees clinical trial sites, in accordance with ICH GCP, FDA and TPD guidelines and standard operating procedures, monitoring plan, project timelines and projected budget;
• Oversees monitoring activities, including site selection and qualification, periodic monitoring, data query resolution and study close out activities.
• Conducts quality control visits and monitors, as needed
• Contributes to the development of regulatory submissions and clinical documents including, protocols, CRFs, informed consent forms, investigator brochures and other site training and clinical support documents including operations manuals and guidelines
• Utilize clinical knowledge to improve clinical compliance across department and at external sites with compliance issues
• Assist in Audit follow-up including response to audit and site CAPA process and re-training
• Oversees product and trial supply accountability at investigational sites; assist in resolving issues
• Oversees and conducts study-specific teleconferences and investigator meetings, as needed
• Works under general direction. Exercises judgment within generally defined practices and policies in selecting methods and techniques.

Requirements:

• Strong study management track record showing clear proficiency in clinical project management skills, including budget development and tracking, site monitoring and CRA oversight. 
• Solid vendor management skills
• Broad understanding of operations including those in related development functions
• Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
• Demonstrated knowledge of ICH GCP, FDA and TPD regulations; certification an asset
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
• Demonstrates ability to lead multi-disciplinary teams
• Possesses excellent written and oral communications skills
• Minimum BS/ RN/ Pharmacy Degree or higher and 5+ years of relevant work experience;
• Ability to travel up to ONLY 20% of the time.

The primary functions include strong and positive employee relations, ensuring excellence and quality and efficient utilization of resources and budget implementation. This role is key in fostering a culture of quality and internal and external customer service by adhering to programs and policies that consistently promote service, quality and customer satisfaction. This role works very closely with employees and colleagues and is an important member of the Patient Services management team.

RESPONSIBILITIES:

* Foster an environment of positive employee relations and strong teamwork while working in compliance with established human resources policies and practices.
* Address staff concerns and inquiries by investigating and handling employee issues and concerns in a timely manner.
* Manage location staff requirements; this includes hiring, training, performance evaluation, coaching and recognition.
* Liaise with clients to ensure proactive customer-oriented services are provided by offering professional assistance, training and interpretation of departmental information.
* Continuously improve workflow in locations to assure consistency and quality in the delivery of service to the patients, lab and clients.
* Responsible for developing and administering regional location budgets, identifying potential cost saving initiatives, administration of annual personnel and operating budgets.
* Completing various locations operating reports; ensuring their accuracy, timely completion and executing remedial action where necessary.
* Stay informed of new industry or regional trends, developments, laws and regulations, and technology with respect to the health care industry and related discipline, and movement of competitors and external clients.
* Conduct regular and consistent communication meetings with staff to ensure attainment of departmental goals and objectives are achieved.
* Support Business Development with the establishment of new clients.
* Oversee maintenance and renovation projects for each location in the region in conjunction with the Director of Facilities.

QUALIFICATIONS:

* Diploma in a health care field, Business or other related field or equivalent experience.
* 3-5 years of demonstrated people management and leadership ability.
* Strong interest for healthcare industry is required.
* Practical experience developing and managing budgets.
* Ability to perform under pressure with competing priorities and deadlines.
* Superior interpersonal, communication and organization skills required.
* MS Office experience in Word, Excel and PowerPoint required
* Demonstrated interest in career development training as asset.

 

Montréal (Quebec)
Canada

EMPLOYMENT STATUS
 Regular - Full Time

POSITION SUMMARY
 Responsible and accountable for overall bio-analytical laboratory resource,
budget and activities. Accountable for all projects' quality and timelines.
Ensure compliance with the regulations and SOPs. Responsible for regulatory
queries relating to laboratory activities. Provide scientific and technical
leadership to the group. As part of responsibility to company's clinical
BE/PK studies, his/her responsibilities including : leading a group of
Scientist and a group of analyst in developing/validating LC/MS/MS assays
for small molecule drugs and metabolites in biological matrices; sample
analysis for clinical BE and PK studies as needed; responsible and
accountable for overall bio-analytical laboratory staff management and
performance appraisal; accountable for laboratory expenses and ensure it’s
within the budget; review and approve data and reports; ensure compliance
with the regulations and SOPs; managing laboratory resources and schedule
laboratory projects to ensure the activities meet company priority and
timeline; provide recommendation and participation in company pipeline
project selection process; proactively collaborate with other
groups/suppliers to achieve continuous process improvement; responding to
regulatory queries in relating to laboratory activities/studies. Provide
expert scientific and technical leadership to the group, mentoring and
guidance to the staff, actively involved in scientific filed and publish in
the scientific journal in regular base, recommend and implement new
technologies in bio-analytical laboratory.

EDUCATION
 Ph. D. or Master's degree in Sciences (Analytical Chemistry or related
field).

EXPERIENCE
 Ph.D degree : minimum of seven (7) years experience. Master's degree :
minimum of ten (10) years experience in the field of bio-analytical and
method development for small molecules. Minimum of three (3) years of
laboratory management and supervisory experience.

OTHER
 Solid knowledge and demonstrated experience with HPLC and LC/MS/MS.
Excellent knowledge of chemistry, chromatography, mass spectrometric
principles and related products. Demonstrated analytical problem
identification and solving skill. Very good understanding of TPD/FDA/EMEA
guideline and requirement as well as knowledge and experience of GLP
regulated LC/MS/MS small molecule bioanalysis. Experience and extended
knowledge in dealing with regulatory agencies’ queries. Good team player and
leader with exceptional communication, laboratory management, supervisory
and interpersonal skill. Strong publication/presentation record and a
recognized expert in bioanalytical for small molecules field.

IMMEDIATE SUPERVISOR
 Biopharmaceutics and Clinical Research Director

 

Perform statistical design, modeling, and analyses.
Responsible for the statistical integrity and accuracy for all phases of
clinical trial studies /databases.
Responsible for generating all tables and graphs to be used in clinical
reports and regulatory submissions and provide quality control as needed.
To maintain and update relevant statistical SOPs.
Interact and consult with scientists to ensure proper use of statistical
methodology and interpretation of results.
May respond to questions from regulatory authorities on statistical issues.
Perform any other task as requested by his/her superior.
   Education and experience :

Ph.D. in Statistics (preferably Biostatistics)
Minimum 3 years biostatistics experience, in the pharmaceutical industry.
   Skills required:

Strong knowledge of programming
Strong working knowledge of SAS
Flexibility and capacity to adapt to changing needs
Well developed critical/analytical thinking skills
Well developed interpersonal, team and communication skills
Ability to work in a fast-paced, team-oriented environment
Fluency in English (French speaking is an asset)

 

Our client, in Toronto, is currently seeking three Senior
Formulation Scientists with a MSC or PHD in Pharmaceutics and 4-6 years
hands-on formulations experience in the solid dosage controlled release
environment. An excellent opportunity for the right individual to hone their
Pharmaceutical skills in a fast-paced setting. Salary to 90K, plus bonus. We
also have numerous similar positions in the Montreal area, where
bilingualism is a bonus. Interested applicants should forward their resumes
to the email address below.

 

Participate in individual AE/ADR case processing, as assigned and as per
appropriate SOPs;
Participate in periodic safety database review and joint QA/PVG meetings;
Organize and participate in PVG related meetings and prepare minutes;
Participate in the development and review of safety related materials
pertaining to clinical trials (IB, ICF, etc);
Participate in SOP and CCSI document development;
Participate in PVG training material development and update PVG training
records;
Maintain and track PVG / Medical Information related data;
Code and file documents related to PVG and Medical Information (including
electronic filing in I-Share);
Assist the Associate Director, PVG in collecting, reviewing and filing of
PVG agreements/ documents;
Conduct focused literature searches;
Perform other duties assigned by your superior/management.
   Education and Experience:

BSc. in biological science, preferably RN, BSN, Nurse Practitioner,
Pharmacist, Physician Assistant or related degree
Min. 5 years experience in Pharmacovigilance or clinical research
International experience would be an asset
   Skills:

Good understanding of TPD, FDA and international regulations pertaining to
Adverse Events and Product Complaints
Basic knowledge of Good Clinical Practice, ICH, FDA regulations and of the
clinical trial process prior to executing monitoring activities
General knowledge of industry practices and standards
Working knowledge of scientific terms and medical terminology
Good basic understanding of MedDRA
Good basic computer and Microsoft Office skills (Word, Excel, Powerpoint)
Ability to analyze and summarize information
Detailed understanding of safety processes
Qualities of a team player
Exceptional attention to detail
Professional demeanour and good interpersonal skills
Excellent verbal and written communication skills (English/French)
Excellent planning and organizational skills
Ability to work independently, multitask and prioritize workload to meet
tight deadlines
Ability to identify project-related problems

 

Responsibilities:
• Support the 1-800 technical help line to technicians in the field
• Receive support requests from technicians. Research and respond with a
resolution within TAT guidelines
• Provide Tier 2 support, product information  to our  French speaking
customers
• Provide Tier 2 support to our Customer Information Centre for our LCD TV
Triage program
• Provide escalation support for the Customer Information Centre
• Collect product information from support groups and communicate that
information with all stakeholders.
• Prepare service publications (bulletins, repair tips & service guidelines)
based on the provided information and feedback from the field.

Qualifications:
• Must be bilingual in English and French (written and spoken)
• A+ Certification and proficient in Microsoft Office
• PC service skills
• AV service skills an asset
• Excellent communication and interpersonal skills
• Good negotiation skills
• Strong analytical and problem solving skills
• Knowledge of SAP would be an asset
• Ability to thrive in a dynamic work environment
• Strong customer relationship skills
• High tolerance for a fast paced, demanding environment