Hess Associates - Current Openings 711-170 The Donway West
Toronto, ON M3C 2E8
416 447 3355
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Biopharmaceutical Positions

2586 Regulatory Affairs Sr. Manager New England 2582 Sr QA Medical Device Testing Engineer GTA 2581 Medical Device Regulatory Affairs Specialist GTA 2578N Sports Clinic Manager: Physiotherapist or Chiropractor BC 2576 CRO Account Manager Montreal 2577 Executive Level Biopharma Business Development QC 2575 Manufacturing General Manager Medical Device GTA 2573B 2576N Laboratory Services Manager N ON 2568 Phase I Clinical Operations Director/Sr. Manager US Midwest 2567 CRO Phase I Bioanalytlical Lab Operations Director GTA 2551 Diagnostic Imaging FSE Specialist NYC 2528 GLP/GCP Immunoassay Development Leader GTA 2509N PhD Clinical Psychologist (Adults) f/t or p/t GTA 2490 Associate Director, Preclincal Toxicology Montreal 2456 Sr. GLP QA Auditor (Preclinical CRO) QC 2451 Sr. CRO Study Director Preclinical Toxicology Montreal

Job ID: 2586
Position: 2586 Regulatory Affairs Sr. Manager New England
Location: New England, NE
Description: New England pharmaceutical company is looking for a Sr. Manager for its Regulatory Affairs department. In this role, you will be responsible for worldwide strategy, related to successful submissions, and domestic and international approvals. ROLE AND RESPONSIBILITIES: - International and domestic strategies for document submissions, project and drug product approvals, labeling, clinical trials, marketing. - Team supervision, regulatory representative at internal and external meetings. REQUIREMENTS: M.Sc., Ph.D., DVM, PharmD preferred. RAC nice to have. Experience in pharmaceutical regulatory affairs - 10 years - may consider slightly less. Management of people and team - best at very senior manager or director level. Background with FDA and international bodies. Best to have worked with products, and documents for products, on or coming to market. Able to relocate to New England as required. Apply


Job ID: 2582
Position: 2582 Sr QA Medical Device Testing Engineer GTA
Location: Toronto, ON
Description: North Toronto medical device OEM/R&D company has a full time position for an experienced Sr. QA Tester. You will be involved in all phases of medical device software and hardware testing, writing test plans, reports, and playing an important role in product development, testing, and validation. ROLE AND RESPONSIBILITIES - Design and execute test procedures you will use to test all aspects of the product, encompassing integration, regression, verification and validation and results analysis. - Maintain testing records, including defects, problems of hardware and software. - Help engineering department plan and carry out product development. - Time lines, review meetings, writing test plans and reports. - Participate in document control and interdepartmental collaborations, - Corrective action planning - for both customers and management. - Follow all policies and procedures, H&S, legal requirements, change orders. - Process validation, automated testing, quality issues and procedures. REQUIREMENTS - 4 year B.Sc. preferably in Electrical or Mechanical Engineering. - 4 to 6 years' (after graduation) work history related to planning and executing testing activities on medical device software, hardware, ultrasound imaging, electronics and complex systems. - 4 years' as a QA Tester creating test plans, and carrying out system and integration level testing, and creating reports related to medical device product development. - Prefer experience with test regression tools (such as HiTest, WinRunner, others). - Excellent knowledge of Quality Assurance methods / Software QA, defect tracking software packages / auditing. - Background in a clinical or clinical manufacturing environment greatly helpful. - Any 9001 / 13485 quality standard desirable. - Excellent English and interpersonal communication, leadership, computer, and organizational skills. - Able to think, challenge, ask questions, troubleshoot, be autonomous. - Available nights or weekends on occasion as required. - This is an on-site position near North Toronto, Newmarket, Vaughan. . Apply


Job ID: 2581
Position: 2581 Medical Device Regulatory Affairs Specialist GTA
Location: Toronto, ON
Description: Toronto based medical device company developing surgical suite imaging products requires a Regulatory Affairs Specialist, reporting to the Director of Regulatory Affairs. You will be preparing documentation and submissions for Health Canada, the FDA, international regulatory agencies such as the European Device Regulatory Agencies (EU regulatory bodies), PMDA (Japan), CFDA (China), and others. Focus is on medical device regulatory requirements and submissions. This is a rapidly growing organization, fast-paced environment, and a very exciting place to work. ROLE AND RESPONSIBILITIES: - Prepare documents and submissions going to North American and off-shore regulatory bodies for product approval. - Communicate with off-shore consultants to ascertain that you are providing the exact details to the regulatory agencies. - Documentation will include technical and labeling information and any additional info requested by these bodies. - Work with variety of engineers to ensure that you grasp the essential concepts and convey these in your submissions. - Keep all registrations, listings, CE technical files up to date. - Serve as SME during quality system audits. - Attend product meetings, help update SOPs, keep current with any changes in regulatory issues. REQUIREMENTS: - BS, B.Eng., Biology, Life Sciences degree. - Able to work on site in Toronto. - >5 years working as a regulatory affairs specialist, preparing regulatory submissions - domestic (Health Canada) AND foreign (FDA, CE (EU), Asia) for medical devices. - Experience preparing technical files and 510(K) documents. - Background with any medical device surgical navigation instrumentation, software, etc. of great interest. - Excellent English communication, troubleshooting, detail-oriented skills. Apply


Job ID: 2578N
Position: 2578N Sports Clinic Manager: Physiotherapist or Chiropractor BC
Location: Kelowna, BC
Description: We are recruiting for a Manager for a BC multidisciplinary sports clinic. The successful candidate will be an experienced and BC licensed physiotherapist or chiropractor. Company will relocate as required. RESPONSIBILITIES: The Clinic Director is responsible and accountable for the leadership and overall success of the clinic. Oversees all internal operations related to clinical quality, staff development and patient satisfaction. Drives financial performance through business development activities and customer service. This role will appeal to physiotherapy or chiropractor candidates who are seeking a career opportunity and are committed to the delivery of excellent clinical services and the professional development of a high performance team. Aggressive growth strategies and patient satisfaction are key business indicators. DUTIES AND RESPONSIBILITIES: Ensures quality improvement in the delivery of patient care. Performs chart audits, maintains standards for communications, participates in education programs both internal and external. Adheres to effective and efficient clinic and corporate operating procedures. Maintains a partial clinical caseload. Responsible for annual business plan. Monitors financial performance, customer service programs and patient/physician satisfaction. Demonstrates leadership and expertise through mentorship. Develops corrective action plans when necessary. QUALIFICATIONS: Registered member in good standing with PT or Chiropractic BC professional college. Undergraduate university degree and related post graduate credentials. Minimum 5 years of clinical experience. Strong communication and problem solving skills. Effective listener, goal orientated, good people skills. Apply


Job ID: 2576
Position: 2576 CRO Account Manager Montreal
Location: Montreal, QC
Description: Montreal, QC rapidly growing GLP preclinical research organization is looking for an experienced CRO Account Manager to advance their already very successful endeavours. They provide preclinical services to the global biotechnology and pharmaceutical industries. The company prides itself on maintaining a family atmosphere and excellent working conditions. RESPONSIBILITIES: Becoming familiar with the practices and goals of a Canadian-based preclinical CRO. Meeting set targets within this industry. Expanding the client base as well as managing and growing existing accounts. Leveraging personal industry contacts to enable business and growth. Working together with the scientific team to determine the appropriateness of new opportunities. Making sure accurate and detailed proposals are given to clients. Remaining highly visible to clients and monitor customer satisfaction. Efficient use of contact CRMs. Contract negotiations, trade shows, conferences. REQUIREMENTS: B.Sc. or higher. 5 years' experience in business development leadership positions within healthcare. Preference for a background with a GLP preclinical CRO OR history within a clinical (phases I through IV, CRO, with the ability and desire to adapt. Proven track record of increasing sales. Pertinent contact list attractive. Desire to grow in the preclinical space. Willingness to live in the Greater Montreal area. - Some overnight travel required. - You would require an appropriate passport, allowing you to travel outside Canada. Apply


Job ID: 2577
Position: 2577 Executive Level Biopharma Business Development QC
Location: Montreal, QC
Description: Montreal, QC rapidly growing bioresearch organization, providing services to global biopharma, is looking for a seasoned, acknowledged very senior business development executive leader to advance its already very successful endeavours. The company prides itself on maintaining a positive atmosphere and excellent working conditions. RESPONSIBILITIES: Becoming familiar with the practices and goals of a Canadian-based biopharma service organization. Meeting set targets within this industry. Expanding the client base as well as managing and growing existing accounts. Leveraging personal industry contacts to enable business and growth. Working together with the scientific team to determine the appropriateness of new opportunities. Making sure accurate and detailed proposals are given to clients. Remaining highly visible to clients and monitor customer satisfaction. Efficient use of contact CRMs. Contract negotiations, trade shows, conferences. REQUIREMENTS: B.Sc. or higher. 5 years' experience in business development very senior leadership positions within healthcare. Preference for a background within biopharma/ clinical research services. Proven track record of increasing sales. Pertinent contact list attractive. Willingness to live in the Greater Montreal area. Territory may include parts of Europe and/or the USA. You would require an appropriate passport, allowing you to travel to the US and Europe. Apply


Job ID: 2575
Position: 2575 Manufacturing General Manager Medical Device GTA
Location: Woodbridge, ON
Description: A Toronto area small manufacturer of medical devices and involved in designing, manufacturing and assembling products for the medical community is looking for a General Manager, Manufacturing. The focus of this position is P & L as well as strategic planning, regulatory oversight, customer development and overseeing new product designs. RESPONSIBILITIES: - Manage sales, engineering, manufacturing, supply chain, and new product development with total Profit and Loss responsibility. - Ensure products meet ISO 13485 and ISO 9001 standards. - Introduce policies and programs affecting the scheduling, quality and cost of manufactured products. - Provide leadership to various areas of the organization. - Adapt leading edge technology to meet the company's competitive advantages. REQUIREMENTS: - BS Engineering education, and manufacturing management background. - Minimum of 5 years managing P&L with a track record of profitable growth in manufacturing. - History of strategic initiatives to insure profitable growth. - Experience with ISO 13485 and ISO 9001. - Working with integrated IS/MRP/Accounting systems as well as shop floor planning aids. - Totally prefer background in medical device, but aerospace or automotive considered. - Strong Customer and Quality focus Apply


Job ID: 2573N
Position: 2573B 2576N Laboratory Services Manager N ON
Location: Owen Sound, ON
Description: Healthcare organization in Cottage Country, Owen Sound, ON is looking for a Laboratory Services Manager. RESPONSIBILITIES: - Lab operations - meeting accreditation, regulatory requirements, QMS, quality patient care services related to lab services. - Operations and HR budgets. - Audits, budget administration, resource allocations, capital purchases. - Staff - hiring, performance appraisals. - Good at working with Clinicians, other Managers re operational and patient care issues. - Helping to develop and implement emergency and disaster planning. REQUIREMENTS: - Bachelor of Medical Laboratory Science OR College Certificate in Medical Laboratory Technology. - CSMLS Certification. and registered with CMLTO. - Min 5 - 7 years of clinical experience. - Min 3 years' leadership experience in a medical laboratory setting. - Strong background in Chemistry, Hematology, Transfusion Medicine. - IQMH and regulatory requirements. - Excellent lab software, union, English communication, decision making skills. Apply


Job ID: 2568
Position: 2568 Phase I Clinical Operations Director/Sr. Manager US Midwest
Location: St. Louis , MO
Description: Phase I Clinical research organization CRO in the Greater St. Louis area is looking for a Clinical Facility Operations Director OR Senior Manager to oversee all aspects of the daily operation of the clinic facility, planning, organizing and overseeing clinical activities related to each study - clinical procedures, recruitment, and screening. This is a senior position for an experienced specialist. GCP adherent. ROLE AND RESPONSIBILITIES: - Operation of Phase I clinic facility on daily basis - study clinical procedures, recruitment, and screening volunteers - all under GCP. - Planning study arrangements with Project Management such as clinic scheduling and assignment, and dosing schedules, and assigning study and screening coordinators accordingly. - Ensuring that studies meet protocols, clinic operation and safety, realistic timelines. - Staff responsibility including training to avoid or correct errors. - Ensure that study schedule meets timelines by working together with other departments such as Quality, PK, Bioanalytical. - Supply chain, pharmacy, special client requests. REQUIREMENTS: BS/MS/PhD/Pharm degree - medically related background preferred. 7-10 years' Phase I CRO direct experience. SME on Phase I with the “on the floor” experience a must have. Experience working with other clinical departments including bioanalytical, PK, QA, CDM to ensure study is delivered on schedule. Hands-on familiarity with early phase clinical trials, study operations and documentation. Excellent interpersonal, organizational, computer, and English communication skills. Able to work alone or as a team player. Apply


Job ID: 2567
Position: 2567 CRO Phase I Bioanalytlical Lab Operations Director GTA
Location: Toronto, on
Description: Clinical research organization CRO in the Greater Toronto area is looking for a Phase I Lab Operations Director to oversee all aspects of laboratory operations and research and development. This is a senior position for an experienced specialist. Clinical phase - not preclinical. BA/BE, ADME focus. Focus on the bioanalytical side. ROLE AND RESPONSIBILITIES: - All clinical laboratory operations under GLP. - Equipment related to all bioanalytical analyses - bioequivalence, bioavailability, ADME. - SOPs, method development, validation, data integrity, regulatory. - Staff management, review, performance management. - Client interaction. - Contract management. - Health and safety. - Keeping lab totally up to date REQUIREMENTS: M.Sc. 12 years' working in a lab including if possible a bioanalytical lab. Background doing drug analyses in biological samples under GLP. BA/BE, ADME studies. Experience in a leadership role. Experience with all of the roles and responsibilities mentioned above. This is a key position in terms of having the company keep totally up to date in terms of bioanalytical services and development. Apply


Job ID: 2551
Position: 2551 Diagnostic Imaging FSE Specialist NYC
Location: New York, NY
Description: Prestigious Manhattan health care center is recruiting for a diagnostic medical imaging instrumentation repair specialist. ROLE AND RESPONSIBILITIES: Maintain, repair medical imaging equipment routinely used for heart, brain, other imaging, such as X-Ray, Fluoroscopy, MRI, CT, ultrasound, nuclear medicine. REQUIREMENTS: BS Electronics/B.Eng./BS Biomedical/ OR A.S. Degree in related field. 3 years doing biomedical instrumentation medical imaging equipment maintenance and repair. One year up-to-date, recent or current work. Focus on medical imaging modalities, not other types of hospital lab equipment such as analyzers, etc. any knowledge of PACS/RIS very helpful. Excellent English, organizational, interpersonal, team player skills. Apply


Job ID: 2528
Position: 2528 GLP/GCP Immunoassay Development Leader GTA
Location: Toronto, ON
Description: Drug development client in Toronto is looking for a GCP/GLP supervisor. You will oversee bioanalytical immunoassay method development as carried out by the CROs to which they outsource their drug testing requirements. Background required would be a combination of experience and leadership in both bioanalytical chemistry and immunoassay, immunogenicity, ligand binding methodologies. RESPONSIBILITIES: Project management and relationship building. Bioanalytical method development and supervision. RFPs, contributing to regulatory submissions. Communicating with global CRO’s virtually. Ensure that CROs follow SOPs and GLP. Devise method development training programs. This position requires 100% excellent English communication skills as it is very client-facing. REQUIREMENTS: B.Sc./ M.Sc. Life Sciences /related. GCP/GLP background. Experience in method development for bioanalytical/immuno assays. MUST have excellent English communication skills as this is a client facing position. 4 years' designing and/or managing clinical trials. Background managing large projects. Regulatory affairs. Multitasker, computer literate, independent and team player abilities. Apply


Job ID: 2509N
Position: 2509N PhD Clinical Psychologist (Adults) f/t or p/t GTA
Location: Toronto, ON
Description: A private global mental health organization is recruiting for a Clinical Psychologists (PhD) for their Mental Health Assessment Departments in Toronto, ON. Must have CBT experience, working with adults. Full or part time. ROLE: The Clinical Psychologist will have the opportunity to help further embed mental health with the Annual Health Assessment, and/or see clients for ongoing care in the private practice. KEY ACCOUNTABILITIES: Review and interpret client screening results and adapting an assessment in real time to reflect client profile and self -identified goals and needs Leverage evidence-based strategies such as Cognitive Behavioural Therapy, Positive Psychology and Motivational interviewing Assist in the development of a client action plan to address current or potential future obstacles and challenges, build on sustain resiliency and renew or improve performance Building strong relations with the Client's Annual Health Assessment team to coordinate care and enhance the client experience Prepare a summary report to reflect relevant client insights and action plans which may include referrals and resource recommendations. PRIVATE PRACTICE: Coordinate independent psychological assessments; providing diagnoses and recommendations for ongoing treatment as appropriate. Develop and communicate with client-centered treatment plans that meet both client goals and address the client's psychosocial and behavioural challenges. Provide empirically validated treatment measures; training and experience in Cognitive Behavioural Therapy required. Collaborate with the client's existing treatment team to coordinate care. Maintain documentation as required. RESPONSIBILITIES: Conducting independent psychological assessments of clients referred to the client from various referral sources. Providing a diagnosis and recommendations for further treatment as appropriate. Developing and communicating a treatment plant to the client, multidisciplinary team, other stakeholders and referral sources. Preparing documentation and formal narrative reports for the referral source. Providing treatment to client, enabling clients to reach their full functional and work re-integration potential in collaboration with clients, treatment teams and all stakeholders. QUALIFICATIONS; PhD in Clinical Psychology Current registration in good standing with the College of Psychologists of Ontario. CBT and short-term therapy training are essential. Minimum 3-5 years clinical experience with adults, preference working with executives. Declared competency in Health Psychology an asset for the population required. Background working with business executives of great interest. Apply


Job ID: 2490
Position: 2490 Associate Director, Preclincal Toxicology Montreal
Location: Montreal, QC
Description: POSITION: Associate Director, Toxicology with a rapidly growing preclinical GLP contract research organization (CRO) based in Montreal. LOCATION: Montreal, QC REPORTS TO: Toxicology Director ROLE AND RESPONSIBILITIES: - Supervising a number of Study Directors. - Undertake a SD role as required re non-clinical safety studies for key clients, large projects, and specialized study types. - Play a significant role in training of less experienced toxicologists. - Advise clients on study design and regulatory issues. - Take a leading role in in-house committees and task-forces, sales and marketing events. - Act as Toxicology Director re staff management, special projects, review of study plans and reports. - Expertise in a specific area of non-clinical safety assessment, as demonstrated by publications (e.g. abstracts, posters, papers), and/or invited lectures, etc. - Key person for training of staff, interacting with sponsors, and undertaking management responsibilities. REQUIREMENTS: Ph.D. in a relevant field, or B.Sc./M.Sc. with DABT Board Certification in Toxicology, or equivalent professional qualification. 5 years' as Senior Toxicologist, Study Director, Senior Research Scientist, or a suitable combination of toxicology -relevant scientific and technical experience. Small animal R&D, re PK, TK, ADME study experience. Require deep understanding of toxicology and regulatory issues - PK, TK, related, interpretation of study director reports. Excellent time management skills and attention to quality. Must be Canadian citizen or Canadian permanent resident, in Canada or able to return. Apply


Job ID: 2456
Position: 2456 Sr. GLP QA Auditor (Preclinical CRO) QC
Location: Montreal, QC
Description: Montreal CRO preclinical testing laboratory seeks a GLP QA Auditor to monitor studies, systems, data, and procedures to make sure that work is done in compliance with GLP. ROLE AND RESPONSIBILITIES: - Audit toxicology study plans, reports, raw data re completeness, accuracy and GLP compliance. - Investigate the critical phases of all preclinical studies re method validation, sample analysis for compliance with study plans, to ensure compliance with SOPs, GLP. - Attend an average of 4 necropsies procedures per month. - Write inspection reports, finalize reports and audit sub-contractors. - Communicate non-compliance to study personnel, directors, and management and recommend corrective action. - Audit facility/laboratory as required. - Make sure there are written and signed records of auditing activities. REQUIREMENTS: B.Sc. or DEC with several years working in a GLP unit. QA inspection/audit experience with respect to toxicology and related preclinical studies. Must be willing to attend necropsies. Excellent comprehension of Good Laboratory Regulations. Able to train others. Strong English and French communication skills. Detail oriented with excellent interpersonal, organizational, or team player skills. Apply


Job ID: 2451
Position: 2451 Sr. CRO Study Director Preclinical Toxicology Montreal
Location: Montreal, QC
Description: Montreal, QC preclinical testing laboratory seeks a Toxicology Study Director to be responsible for toxicological (GLP) investigation of pharmaceuticals. ROLE AND RESPONSIBILITIES: Designing protocols and programs. Overseeing all technical and scientific activities and in-life monitoring. Responsible for overall conduct of pre-clinical drug studies. Communicating with sponsors. Interaction with internal (QA, Bioanalytical) and external customer/s Writing reports, protocols, and evaluating data. Serving as the scientific representative on corporate committees. Attending scientific meetings. Training of junior technical and scientific personnel. Carry out R&D in line with company objectives. REQUIREMENTS: BSc. (min) plus 5 years as a Tox Study Director in the CRO, biotechnology, OR pharmaceutical industry. Experience with safety studies of biologics and drugs. Background in the review and tabulation of study data (PK analysis). Knowledge of ADME studies (Absorption, Distribution, Metabolism and Excretion). Able to provide quotes for new incoming studies. Excellent organizational, protocol and report writing skills, working knowledge of GLP, SOPs. Please note that this is GLP, not GMP or GCP. Hands-on, able to deal with the animal experimentation side of testing. French / English bilingual nice to have. Apply