PHARMACEUTICAL                                                                                                                                                     

                  

J. Edgar and Associates Inc. has been serving the  Pharmaceutical arena since 1998. We source Supervisory and support staff for Management, R&D, Engineering, Quality, Materials and Sales. If you are currently in the market for a new employment opportunity, we invite you to view the current opportunities below.

Hot new jobs...Medical Information Advisors...Business Development ...Health Outcomes Manager...Director Medical and Scientific Affairs...Pharmacy Regional Manager...Pharmacists...Regulatory Affairs Manager...Director Scientific Specialist...Medical Scientific Specialist...Pharmaceutical Validation Manager...Medical Liasons...Six Sigma Process Engineer...Pharmaceutical Formulator...


MEDICAL INFORMATION ADVISORS to $80K plus bonus, Montreal and Toronto

 

We are currently looking for Medical Information Advisors/Specialists for Montreal and Toronto.  You must be bilingual in English and French and possess a degree in Pharmacy or a Pharm D.

 

Assets to this role would be strong therapeutic knowledge in CNS, CV, GI and Respiratory.  The main functions of this position are providing medical expertise and support to cross-functional therapeutic teams while accurately documenting and reporting adverse effects and providing answers to high-level customer inquiries.

 

Experience writing medical and scientific information with a high degree of accuracy and detail is highly regarded, as you will be informing physicians, health care professionals and patients.

 

You require a degree in Pharmacy plus experience working as a Pharmacist or as a Medical Information Specialist within the pharmaceutical industry. 

 

Positions are based in Montreal and Toronto. Bilingualism in French and English is required for the Montreal position 

  

Call Jason Edgar  at 416 225-2628 for all the details. mailto:careers@jedgarcareers.com


BUSINESS DEVELOPMENT OPPORTUNITY for BIOTECH COMPANY, $150K  plus BONUS

We are seeking a Business Development Director in the Pharmaceutical or Biotech industry experienced with In-Licensing and Out-Licensing agreements. The candidate must have a very strong scientific background in Oncology or Virology and be very familiar with “transfection”.

 

Licensing business development experience is required.

 

The role will work closely with the head of Marketing to isolate and analyze prospective out-licensing partners and to increase the market awareness of our clients unique transfection technology in North America and globally. As licensing agreements are based on volume for milestone manufacturing and royalty payments, it is important to have experience with large account development.

 

Qualifications:

 

Familiarity with the Pharmaceutical and/or Biotech Business in North America and preferably globally as well as solid knowledge and extensive experience in the areas of marketing, business development, project management and finance. We require strong quantitative, analytical, data interpretation and problem solving skills as well as being well versed with current standard and sophisticated market research tools, economic and financial modeling. Highly developed communication and interpersonal skills are required as well as strong contract negotiation skills.

 

Educational Requirements: MD, Ph.D. or Phm.D.

An MBA is an asset.

 

Salary: $100-$150K plus bonus of up to 50% and full benefits.

 

Call Herb Botkin at 416 225-8071 mailto:hbotkin@sympatico.ca  


 

HEALTH OUTCOMES/ MARKET ACCESS MANAGER  to $110K, Montreal, Quebec         

 

We are currently seeking a Health Outcomes/ Market Access Manager with experience in Health Outcomes, Endpoints, Clinical Statistics, Population Databases and Epidemiological Studies to assist in the design and implementation of health economics and drug reimbursement strategies for internal and external stakeholders. You will work in a collaborative role with the team in Pricing and Drug Plan Affairs.

 

The main objective for this role is to develop public and private market strategy utilizing private usage data on key products to detect trends and develop business growth and refine all processes within this area of the business. You will identify critical outcomes research needs in order to optimize market access. As well, this position participates in advisory boards, symposia and other regional/national professional meetings where relevant clinical and outcomes research are presented and discussed.

 

The Health Outcomes/Market Access Manager develops tools and materials required to access and engage public and private payers’ interaction with our District Managers while supporting the development of a training and activity plan for DM’s.  In this role, you will be required to foster the development of strong relationships with public and private payers, benefit consultants and KOLs, in order to optimize coverage – which involves negotiation support with public and private payers to optimize formulary listing. You will proactively validate the level of key products and identify key Patient Advocacy groups and develop strategies to foster strong relationships with them.

 

Qualifications

 

You must have a University degree in business or life sciences with 5 years experience in the Pharmaceutical industry or health care sector, preferably with a public or private payer. You should have experience in product or health outcomes management. Knowledge of the CV/CNS Categories would be helpful and bilingualism in English and French is required. An MBA or equivalent would be a valuable asset in this highly analytical and program development oriented role.


Salary is to $110K plus a bonus potential of up to 18%.

Full benefits apply.

Call Herb Botkin at 416 225-8071 mailto:hbotkin@sympatico.ca


DIRECTOR OF MEDICAL AND SCIENTIFIC AFFAIRS  to $250K, Montreal, Quebec

 

We are currently seeking an experienced Associate Director or Director of Medical and Scientific Affairs.  The position calls for an MD, PhD or PharmD in the Health or Life sciences area.  The ideal candidate has extensive knowledge of the Pharmaceutical industry with a minimum of 5 years in the industry.

 

Your eligibility is based on a strong background in the Professional, Scientific and Business domains within the Pharmaceutical world.  This position requires more than an exclusively academic background.  As a Medical and Scientific leader in a Pharmaceutical environment, you will have strong management experience and dynamic communication and negotiation skills.

Your experience in the Canadian healthcare system and marketplace is also crucial for this role, as you will be working in a business, team-based environment working closely with 2 groups of Medical and Scientific Liaisons for unique therapeutic categories. 

You must be Bilingual with English and French, and the aforementioned credentials are absolute requirements.

 

Salary is in the $170K - $215K plus bonus and the location is Montreal.

 

Call Herb Botkin at 416 225-8071 mailto:hbotkin@sympatico.ca


PHARMACY REGIONAL MANAGER, to $110K, Toronto, Ontario

While being centrally located at Head Office in Toronto you will be responsible for a network of approximately

10 dispensaries in southern Ontario. Although background knowledge in specialty pharmaceuticals is helpful, we

will provide the necessary tools and training in this field to ensure you will be able to assume the leadership role

of this key network in the health care delivery system. As a Regional Pharmacy Manager you will be responsible

for creating a viable working group among your team of local pharmacists by maintaining the highest professional

level of customer care for this fragile patient population that your dispensaries serve. 

 

This position is responsible for the adherence to company policy and Regulatory guidelines. 

 

Position Highlights:

 

Continuous professional development so you are familiar with the most recent  developments in Pharmacy.

Through your team of dispensing pharmacists, you will establish and maintain a positive relationship with your

patients by providing state of the art consultation services to build trust and confidence in them. You will be

responsible for leading and coaching the dispensary staff so they provide customer focused patient care in a

discreet and confidential manner in all pharmacy dispensary matters. You will develop and implement short

and long term business plans that are aligned to the corporate marketing and growth objectives.  

 

Qualifications:

 

Valid pharmacy license with no restrictions to practice in Ontario

Background experience with a Regulatory body or Professional Association

Previous pharmacy dispensary experience

Excellent and effective communication & interpersonal skills

The capacity to manage a geographically dispersed network of dispensaries

Giving priority treatment to customers and promoting a first-rate attitude in the treatment of your patients

Committed to regular training and staff development so your team will be acknowledged as the leader in this specialty

field.

 

Compensation: $100-110K plus bonus, car and excellent benefits package

 

Call Herb Botkin for all the details at 416 225-8071 and email CV to: hbotkin@sympatico.ca 


       PHARMACY MANAGERS and STAFF PHARMACISTS to $60/HR for the GTA, NORTHERN, CENTRAL and EASTERN ONTARIO and ALBERTA

We are recruiting teams of licensed pharmacists at both the managerial and staff levels for our network of pharmacies in various regions of Ontario and Alberta. Join our team and share our vision of maintaining the highest professional level of customer care for the patients our dispensaries serve. Our succession plan helps you to see the next three to five years for your continuous growth and opportunities for advancement.

 

All our positions are responsible to adhere to company policies and Regulatory guidelines. 

 

Position Highlights:

 

  • Continuous professional development so you are familiar with the most recent  developments in Pharmacy practice
  • Through your team of dispensing pharmacists, you will work to establish and maintain a positive relationship with your patients by providing state of the art consultation services to build trust and confidence in them
  • Pharmacy Managers will be responsible for leading and coaching the dispensary staff so they provide customer focused patient care in a discreet and confidential manner in all pharmacy dispensary matters
  • Pharmacy Managers will develop and implement short and long-term business plans that are aligned to the corporate marketing and growth objectives.

 

 Qualifications:

 

  • Valid pharmacy license with no restrictions to practice in Ontario
  • Previous pharmacy dispensary experience
  • Excellent and effective communication & interpersonal skills
  • Giving priority treatment to customers and promoting a first-rate attitude in the treatment of your patients
  • Pharmacy managers and staff pharmacists are committed to regular training and staff development so your team will be acknowledged as the leader in Pharmacy Practice

 

Compensation: $45-$60 per hour with an excellent benefits package. Some hourly rates may increase due to local requirements and needs of the region.

Call Herb Botkin for all the details at 416 225-8071 and email CV to: hbotkin@sympatico.ca 


 

REGULATORY AFFAIRS MANAGER, PHARMACEUTICAL SECTOR, Montreal, to $100K plus bonus

Effectively preparing documentation for NDS, SNDS, NC, CTA to TPD, CDR, and CADTH to gain government registration. You will also negotiate with internal stakeholders in Market Access and Scientific departments to achieve desired regulatory approvals that meet business priorities and strategies for successful marketing of drug products. Your experience demonstrates that you have influenced Canadian Regulatory agencies with respect to compliance to national standards. You have a solid understanding of regulations and policies and you have impacted regulatory changes on business operations and directed implementation of changes to meet new requirements. Other responsibilities include:

1. Representing the company to key stakeholders, regulators and associations.

2. Developing effective working relationships with external medical/scientific expert opinion leaders and with Regulatory Agency reviewers to help influence positive decisions on drug submissions.


3. Liaising with company's Global Product Development Teams to ensure that company requirements are incorporated into the global strategy.

4. Coaching and development of all team members to become regulatory experts within designated therapeutic product areas and building our affiliate talent pool.

Requirements: University degree in relevant scientific field (i.e. pharmacology, pharmacy, toxicology, chemistry etc)
                    A minimum of 5-10 years regulatory affairs experience in the pharma industry with many submissions.
                    Demonstrated people management skills
                    Strong leadership and organizational skills
                    Excellent communication and influencing skills
                    Experience in Quality and Product Safety is an asset

Excellent English and French oral and written skills are a must.

Location: Montreal, Quebec area

Compensation: $95-110K plus bonus.

Call Herb Botkin for all the details at 416 225-8071 and email CV to: hbotkin@sympatico.ca 


3 DIRECTORS of SCIENTIFIC RESEARCH, $130K plus bonus, plus car, Montreal, Quebec

We are currently seeking a Pharmacist or MD or Ph.D. to lead a medical research/drug trials operational department. The position requires someone who can strategically align Medical Activities and allocate resources on research projects locally and globally. The role ensures compliant and timely execution of clinical studies and requires experience as a medical advisor or medical liaison.

The incumbent will lead the work of the Medical Research Group with  Project Managers, Clinical Trial assistants and medical liaisons, ensuring the workload is effectively distributed. The role oversees research activities through proper cross-functional operation management. You have to be able to optimize the financial resources you are allocated through proper budget management. We are seeking someone with strong leadership and managerial abilities in projects and people as they relate to clinical research drug trials.

You will interface with clinicians, investigators and disease-state groups in maintaining a network of experts in CNS or Cardiovascular or Women's Health. You will provide expert opinion on clinical, legal, regulatory, and ethical issues relating to strategy, implementation of new drugs and clinical trials and oversee the communications materials used during pre-launch and launch activities. You will work proactively within the brand teams by developing strategic plans and assigned budgets and initiate and produce educational materials for external and internal clients.

You will educate sales staff on medical issues and respond to medical inquiries related to the field of CNS or Cardiovascular or Women's Health.

You will have input in writing/approving Phase 1V protocols and arranging internal reviews and approvals, recruiting and approving investigators for trials, monitoring Phase 1V trials, analyzing results and preparing data for publication.

Bilingualism is an asset as the position is in Montreal. Approximately 30% travel as the position requires interfacing with medical doctors.

Call Herb Botkin for all the details at 416 225-8071 and email CV to: hbotkin@sympatico.ca 


MEDICAL SCIENTIFIC SPECIALIST, $95-110K plus Bonus - Montreal, Quebec

 We are currently seeking an experienced Medical Scientific Specialist for Oncology in the Montreal area.

 

This position provides scientific information for the up-coming and existing product indications while providing assistance to Medical Affairs, CME's, advisory boards, KOL development, scientific reviews and Investigator meetings.  This position also supports healthcare professionals.

 

As MSS, you will work to identify, develop and manage emerging untapped scientific opportunities for the product and you will effectively interface with the Therapeutic Area Team to ensure optimal implementation of regional initiatives such as CME, Adboards and Medical initiatives.

 

Part of this role effectively interfaces with market access and strategic partnerships to provide regional implementation support that enables resolution of market access and funding issues based on scientific data.  As an advocate, the MSS will build and maintain advanced disease, product and therapy knowledge while meeting with KOL's to discuss studies, research science and innovative development.  The MSS will represent scientific leadership among internal and external customers.

 

You must have a University degree in Pharmacy, a PhD., or be an MD.

Therapeutic area experience is an asset. Willingness to travel up to 20%.

 

Salary range is $95-110K.  Benefits and Bonus apply.

 

 

Call Herb Botkin at 416 225-8071 for all the details, mailto:hbotkin@sympatico.ca


PHARMACEUTICAL VALIDATION MANAGER, to $ 85K, West Greater Toronto

We are currently seeking an experienced Validation Manager for a Pharmaceutical manufacturing environment.  The main focus of the post is to produce operating results by providing supervisory  and administrative support as well as all expertise and direction for the Validation Department.  As Validation Manager, you must be able to delegate work loads, monitor progress, guide personnel and supervise.

 

A major challenge the Validation Manager faces is multi tasking and dealing with client audits on projects that have not met established timelines.  With such diverse problems, solutions often require modifying standard principles or selecting courses of action, which may not be defined in operating procedures.  The Validation Manager has the authority to make procedural decisions on occasion where new circumstances arise but must stay within the guidelines provided.  All disciplinary and employee relations matters are handled by the Validation Manager. The Validation Manager reports to the Director of Quality Operations, has 7 reports and works closely with internal Project Managers, and external Clients and Government bodies.

 

Duties include:

Scheduling and managing day to day activities, coordinating validation activities with other departments to insure completion schedules, plan and implement all validation projects, provide input in the preparation of project proposals and budgets for validation activities, participate in strategy meetings to develop Validation guidelines, Supervise and evaluate subordinate employees and recommend changes in staffing and budgets as needed, review validation protocols and create/update SOPs for the department while acting as the client liaison on Validation issues.

 

You must have:  A Bachelor of Science degree, pref. in Chemistry, minimum of 5 years  Pharmaceutical Validation experience in a management position with a minimum 3 years of Supervisory experience.  Proficiency in English is mandatory.

 

Salary to $85K, commensurate with experience.

Full benefits and group performance bonus.

 

Call Jason Edgar at 416 225-2628, mailto:careers@jedgarcareers.com  


MEDICAL LIAISONS, $100-120K, plus bonus, Quebec, Ontario, Alberta and B.C. Positions for English only and Bilingual are required.

We are currently seeking Medical Liaisons in Quebec, Ontario, Alberta and B.C. This is a home office based position that requires a scientifically educated individual to face customers as a Primary scientific expert in either oncology, immunology, infectious diseases CV or CNS. The position also requires the person to evaluate proposals for investigator initiated clinical trials and have input in their design, and implementation. (Phase 2-4).

You will work closely in a cross functional approach with the existing business unit to identify, develop and manage emerging untapped opportunities for some famous therapeutic products.  You will interface with the clinical research team and the commercialization division to ensure optimal implementation of regional initiatives, CME’s and other Medical initiatives. You must be able to effectively interface with marketing and other internal and external strategic partners to provide regional support and help resolve market access and funding issues. The most suitable candidate is an individual who maintains advanced disease, product and therapy knowledge. You must be a self-directed person capable of learning on your own.
 
Effectively calling on Key Opinion Leaders, is a good part of the responsibility. You will act as a repository for information in the development of scientific materials and a resource for drug safety. You will act as the Canadian expert on the disease category to the medical, pharmaceutical and regulatory communities. We require a pharmacist, MD or Ph.D. with a background in clinical drug trials or clinical research and preferably experience working in pharmaceuticals

Our client would prefer someone with experience in the therapeutic areas noted above. You would be willing to travel for training and congresses. This is a full time position with an excellent benefits package.

Call Herb Botkin at 416 225-8071, hbotkin@sympatico.ca


SIX SIGMA Process Engineer - Senior Leader - to $120K. Toronto, Ontario

We are currently seeking a certified Green or Black belt Process specialist to help drive operational excellence at one of our manufacturing client sites.

 

This position will take the lead in driving strategic operating and business process improvements that support operational excellence, growth and other key continuous improvement initiatives. The role  supports and fosters the principles of operational and manufacturing excellence with lean manufacturing and six sigma doctrines. This role must organize operational excellence activities at the site, leading the site Core Team, during the project phase and then on an on-going basis.  This position develops applicable metrics and reporting in order to track project and future progress. 

The core of the processes includes the lean principles of customer value, demand-pull, continuous flow of product and information, waste elimination and the overall pursuit of excellence. The role will focus on understanding the mutual impact of all of these principles across multi-functions including: production, quality, planning, supply chain, PDS and corporate. In addition, the principles of cycle time reduction, quality, inventory management and operational strategy will shape the magnitude of organizational impact.

Specific duties include: Operational excellence through methods of lean manufacturing, six sigma, pull manufacturing, total productive maintenance, waste reduction in scrap, labour utilization, cycle time,  and WIP.  Assist in the education and training of staff while developing, proposing and helping implement improvement plans for capacity, processes and technologies.

You should have a Bachelors degree in Engineering, Science or Business plus formal Certification in Process Engineering, in either Lean Manufacturing or Six sigma from a recognized authority.  Experience in either Food, Cosmetics or Pharmaceutical manufacturing is an asset.

       Salary: to $120K

       Call Jason Edgar at 416 225-2628,  mailto:careers@jedgarcareers.com  


      PHARMA QC CALIBRATION CHEMIST, to $60K,Toronto, Ontario

One of our clients in the Pharmaceutical world is currently searching for a QC Calibration Chemist for a 12 month contract to maintain the calibration of all QC Lab equipment.  Must have previous calibration experience in a Pharmaceutical setting.  The ideal candidate will review and revise all calibration procedures to existing equipment; development of new calibration procedures for new equipment and assist with IQ/OQ/PQ.  Will also assist with Data interpretation and report writing.  

Must have proficiency with various instrumentation (ph meter, Viscometer, Karl Fisher apparatus, UV, IR, HPLC), good working knowledge of GMP's and applicable software. A B.Sc. in chemistry or equivalent plus 3-5 years of lab experience required.
Location: Toronto.
Salary: $60K plus full benefits.
 

Please call Cris Murray at 416 225-6386  jedgar@sympatico.ca 


DIRECTOR, BIOSTATISTICS, to $120K Toronto, Ontario

We are currently seeking a leader for Biostatistics department at one of our good Pharma client sites.  You must have at least 5 years in Biostatistics plus some management experience. You should have solid experience in SAS as you will be responsible for managing and delegating Biostatistic projects and campaigns. 

 

You must have a Masters or your Ph.D. in Biostatistics from a reputable University.  SAS Certification is an asset.

Salary is commensurate with experience to $120K, bonus and benefits apply.


Please call Cris Murray at 416 225-6386  jedgar@sympatico.ca 


PRODUCT MANAGER, PHARMACEUTICAL INDUSTRY, to $110K, plus bonus, Montreal, Quebec

 

We are currently seeking an experienced Product Manager in the pharmaceutical industry to help roll out  some world-class blockbuster drugs. We are seeking someone who plans, designs, and manages the entire commercialization plans for the assigned products and related services from conceptual stages throughout the product lifecycle to meet sales, marketing, financial, and corporate growth objectives.

 

Duties and Responsibilities:

Participates in the development of the overall product strategy and roadmap within the Product Management team. Conducts and coordinates customer, market, and competitive research to develop product and market access strategies. Helps in determining product placement opportunities within the hospital and physician market and designs market plans in a cross-functional arrangement with scientific/medical research scientists as appropriate. Plans, schedules, and coordinates all product roll-out tasks for new products and product revisions. Prepares product development objectives and schedules for all phases of product development and introduction to market. Collaborates with a wide variety of functional areas such as research, market access, sales, medical information services, marketing,  operations to develop and provide product definitions and promotional information responsive to customer needs or disease state groups. Researches and responds to market and competitive trends.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

·        Tremendous communication, organizational, customer, and problem solving skills

·        Strong leadership and negotiation skills

·        Highly flexible and diplomatic

·        Self directed and self motivated

·        Demonstrated ability to drive projects to closure in a fast paced environment

·        Ability to manage through competing priorities

·        Highly quantitative

·        Creative and positive-minded

 

Education and Experience:

·     Three or more years of product management or product development experience in pharmaceutical industries.

·     BSc., MBA  or a related field.

      Call Herb Botkin 416 225-8071,  mail CV to: hbotkin@sympatico.ca


PHARMACEUTICAL INDUSTRY, ACCESS MANAGER, $95K plus bonus up to 18 %,  Montreal, Quebec

We are currently seeking a Market Access Manager with experience in Health Outcomes, Pricing and Drug Plan Affairs.

 

The main objective for this role is to develop private market strategy using private usage data on key products to detect trends and develop business growth and refine all processes within this area of business.  The HOM identifies critical outcomes research needs in order to optimize market access.  As well, this position participates in advisory boards, symposia and other regional/national professional meetings where relevant clinical and outcomes research are presented and discussed.

 

The Health Outcomes Manager develops tools and materials required to access and engage private payers interaction with District Managers while supporting the development of a training and activity plan for DM’s.  In this role, you will be required to foster the development of strong relationships with private payers, benefit consultants and KOLs, in order to optimize coverage – which involves negotiation support with public and private payers to optimize product listing.  As HOM, you will proactively validate the level of private coverage for key products and identify key Patient Advocacy groups and develop strategies to foster strong relationships with them.

 

You will be responsible for pricing agreements, filings with the PMPRB and provincial regulators.


Qualifications

 

You must have a University degree in business or life sciences with 5 years experience in the Pharmaceutical industry or health care sector, preferably with a private payer. You should have experience in product or health outcomes management. Knowledge of the CNS Category would be helpful and bilingualism  in English and French is required. An MBA would be a valuable asset in this highly analytical and program development oriented role.


Salary is to $95K plus a bonus potential of up to 18%.

Full benefits apply.

 

 

Call Jason Edgar at 416 225-2628 to discuss and please send your CV to mailto:careers@jedgarcareers.com


            SENIOR SCIENTIST, SOLID DOSAGE DRUG FORMULATIONS and DEVELOPMENT, to $130K plus bonus, Florida, USA

 

We are looking for a senior scientist, preferably with a Master’s or Ph.D. in Pharmaceutics or Pharmaceutical Technology, who understands and applies the concepts and principles of drug formulations from a practical perspective. You must have designed formulations for solid dosage and sustained release drugs and have 6-10 years of experience in this work.

 

You will be required to design and interpret experiments and have input into the development of new experimental methods to achieve the desired formulation.

You have direct, hands-on experience in pharmaceutical drug design/development and you have demonstrated your scientific contribution in the field of drug formulations, through published reports, regulatory filings and patent applications. When required you are able to defend your drug development methodologies to colleagues, peers and Regulatory Agencies such as the FDA.

 

You are a meticulous scientist, team player and role model who records, tabulates, summarizes, interprets and publishes results as well as trains others on the operation, maintenance and trouble shooting of instruments, equipment and techniques.

 

You have been effective at representing the product development function to all the project teams and in securing commitments for your development projects across all relevant functional areas. Above all you have a compete understanding of the scale-up and transfer to batch process in manufacturing.

 

 Contact: Herb Botkin at 416 225-8071 and email CV to hbotkin@sympatico.ca


VICE PRESIDENT SALES, GROUP HEALTH to $275K, Toronto, Ontario         

 

We are searching for a high profile, dynamic sales leader with 5-10 years experience as a senior sales and marketing executive in the group health and dental benefits field. Qualifications include a university degree in business, finance or technology. Experience developing and sustaining business relationships with key customers and decision makers at the senior level is required. You must have a track record of developing and implementing strategic selling principles for your sales team.

 

You must have an excellent understanding of the Canadian Health Care Delivery System and the Group Benefits Market from both the public (government) and private (insurance company) perspective and you must have a well-developed network of relationships within the benefits industry.

 

As a seasoned marketer you must have solid skills in promotion/communications, branding, pricing and distribution. As well you must have experience in consulting with operations people as a technical advisor and as an internal strategic partner. You must have the ability to translate the technological needs of your clients into deliverable solutions that meet their requirements.

 

Executive experience in financials is required and Bilingualism is an asset but not mandatory. Salary to $165 base plus up to 60%incentive plus share options- to $275K.

Call Herb Botkin at  416 225-8071, mailto:hbotkin@sympatico.ca


REGULATORY AFFAIRS ASSOCIATE to $60K plus Bonus, Toronto, Ontario

 

We are currently seeking a Regulatory Affairs Associate for a leading Pharmaceutical firm located in Toronto. 

 

As a Regulatory Affairs Associate you are responsible for; File drug product submissions for Canada and the U.S. (e.g. DMFs, ANDS, NDS, ANDA, NDAs,  S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.), for the successful registration of domestic and international drugs and devices, as assigned.  As RAA, obtaining approval of drug product submissions by preparing written responses to deficiency letters from regulatory agencies is crucial.  You will also obtain approval of changes to approved drug products for FDA (CBE supplement, PAS) and TPD (Notifiable Change)and maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).  Assisting in preparation and completion of FDA and TPD pre-approval and GMP inspections is also part of the role.

 

In consultation with the manager, the RAA provides regulatory guidance and expertise to US, Canada, Israel, International Sales & Marketing, R&D, QC/QA, and Operations. Reviewing internal documentation (labeling, master batch records, specifications) and external documentation (clinical reports) for adherence to regulatory guidelines is also part of the work as is; Assisting global drug product registrations, Maintaining regulatory library and Assisting the Manager of Regulatory Affairs as required.

 

You must have; Minimum B.Sc. in Chemistry, Pharmacy or Life Science and at least three years of experience in Regulatory Affairs, expertise in chemistry and manufacturing, labeling and format requirements for drug product registration for FDA (ANDA, NDA, DMF, IND) and TPD (CTA, ANDS, S/ANDS, NDS, DIN, DMF), knowledge of GMP requirements and QA/QC procedures, excellent interpersonal, written and verbal communication skills as well as good computer skills, ability to plan, coordinate and work effectively in a team-oriented environment. 

 

We are looking for a good problem solver with the ability to prepare written responses to deficiency letters from regulatory agencies as this aspect of the work requires the most attention to detail, as well as obtaining approval of changes to approved drug products. 

 

Salary is $55-60K with full benefits and a bonus plan.

 

Call Cris Murray at 416 225-6386, jedgar@sympatico.ca


ASSOCIATE DIRECTOR, QUALITY ASSURANCE for Senior Role, to $130K, USA

Our client requires an Associate Director, Quality Assurance with managerial and pharmaceutical experience for a top management position in the US Pharmaceutical Industry.

 

Responsibilities include developing and approving quality system procedure, SOP’s, OOS reports, validation, specifications and master batch reports as well as product investigation reports, identifying cGMP issues and taking corrective action. You will also manage the QA disposition group, in-process QA group and QA packaging team.

 

You need to be both a skilled team leader to manage the site’s quality review committee and train or certify staff in production, maintenance and QA. You also need to be a team player when assigned to new product teams and lend your expertise to those team members so they have an appreciation for the QA process and their requirements.

 

Your background includes Phase 1-3 and other SOP’s as well as dealing with Regulatory Bodies such as the FDA, DEA, etc.

 

Above all you must demonstrate your ability and experience in creating a viable working group of skilled professionals.

 

This is a full time permanent position with a world-class company.

 

Location: Florida, U.S.

 

Call Herb Botkin 416 225-8071, hbotkin@sympatico.ca


  REGULATORY AFFAIRS DIRECTOR - Pre and Post ANDA  Submissions  to$120K US, plus bonus and incentive, USA

 This position ensures efficient submission preparation in accordance with company priorities as well as Managing the submission review process.  The incumbent will Forecast and manage submission workload in line with corporate priorities. Evaluate files for new products, claims and line extensions, developing regulatory strategies for these projects. Participate in and support product development and advise other
departments on regulatory issues and strategies. Build and maintain external contacts (TPD) as well as internal contacts.
Manage and supervise the work of Regulatory Affairs staff. Monitor and evaluate performance of personnel, develop needs assessment
for their continuous improvement, and support individual development.
Actively sponsor, facilitate and support projects which increase efficiencies and compliance within the Regulatory Affairs department.

SKILLS & QUALIFICATIONS:
Completion of a University level scientific program and at least 3 to 5 years Regulatory Affairs experience, with at least one year of
supervisory experience within the pharmaceutical industry, or an equivalent combination of training and experience.
Sound knowledge of TPD and FDA regulations, guidelines and policies, and at least 10 ANDA submissions. A demonstrated ability to solve problems strategically. Customer focused with strong negotiating skills and excellent written and verbal communication skills. Proven project management skills and detail-oriented.

 Start: ASAP
Location:Two US locations
Salary:  to $120 US, plus bonus, plus incentive.

 Please call Cris Murray @ 416 225-6386 mailto:jedgar@sympatico.ca


   RESEARCH and DEVELOPMENT  FORMULATIONS SCIENTIST to $130 US, USA

The position requires a Formulations specialist to Develop generic products in a timely manner under GLP for ensuring passing biostudies and a smooth transfer of the product to the cGMP area for preparation of bio/submission batches. Create a development report for each product that summarizes in a clear, scientific and logical way, the work performed to achieve the final formula and process. Develop, train and lead a group of scientists and technicians to work in a successful team along with Analytical, Regulatory, Pharma  Tech and Operations departments

Organize the daily, weekly and monthly work and progress through the regular review of scientific data. Organize, lead and report on the scientific R&D monthly meeting. Organize and control the R&D formulation equipment .

All Supervisors and Managers are eligible.

Prepare annual budget proposals

SKILLS AND QUALIFICATIONS

Master of Science degree or PhD degree. 5-10 years of Pharmaceutical Research and Development experience in Formulation and Process Development. Excellent planning, documentation and reporting skills.

Excellent troubleshooting/problem solving and strong analytical skills are required. Demonstrated effective communication skills, both written and verbal. Superior interpersonal skills.

Ability to motivate and positively influence staff to provide the necessary drive to ensure their full contribution and commitment.

    Please call Cris Murray at 416 225-6386   mailto:jedgar@sympatico.ca


  QUALITY ASSURANCE MANAGER/ ASSOCIATE DIRECTOR, R and D, to $ 130 K US, USA

We are currently seeking an experienced Quality Assurance Manager, experienced with solid dosage in the Pharmaceutical manufacturing industry.

The QA Manager is responsible for reviewing and revising quality system procedures, reviewing and approving SOP's, OOS reports, validation reports, specifications, and master batch records as well as preparing and reviewing and approving quality assurance SOP's, forms and product investigation reports. You will facilitate the site quality's review committee and become a member of assigned new product teams. You will have QA management responsibilities for the disposition group, in-process QA group and QA packaging groups. Other responsibilities include the training and certification of production, maintenance and QA staff as well as interacting with FDA and Regulatory agencies. This position requires that you have experience in identifying cGMP issues and ensure appropriate corrective actions are taken. As a senior manager you will follow up on Human Resource related issues promptly and staff your department appropriately.

Qualifications include: Phase 1 (General), Phase 2 (Safety), Phase 3 (Review of all QA modules) and all SOP's as required plus strong management skills as well as being highly motivated and self-disciplined. Additionally, previous interactions with governmental and regulatory agencies and FDA Regulations are required.

A Bachelor's degree and 7-10 years of pharmaceutical industry experience with a supervisory background are required.

Location: United States

Contact: Jason Edgar at 416 225-2628 and email CV to careers@jedgarcareers.com


  MEDICAL SCIENTIFIC SPECIALISTS- MEDICAL LIAISON  - $115 K, for Western Canada

Our client is currently seeking a Medical Scientific Specialist to Manage a territory in Alberta and an other for British Columbia.  This is a home office based position that requires a scientifically educated individual to face customers as a Primary scientific expert in either oncology, immunology,  or infectious diseases. The position also requires the person to design, assist, co-ordinate and implement Phase 1V trials.
 
As the Medical Scientific Specialist/Medical Liaison you will work closely, in a cross functional approach with the existing business unit to identify, develop and manage emerging untapped opportunities for some famous therapeutic products.  The incumbent will effectively interface with the Therapeutic Area to ensure optimal implementation of regional initiatives, CME, Ad boards and other Medical initiatives. You must be able to effectively interface with market access and strategic partnerships to provide regional implementation support that enables resolution of market access and funding issues. 


The most suitable candidate is an individual who maintains advanced disease, product and therapy knowledge. You must be a self-directed person capable of learning on your own, and educating others.
 
Effectively calling on Key Opinion Leaders, is a good part of the responsibility of this post. As well, you will act as a repository for information in the development of Scientific materials and a resource for drug safety. You will act as the Canadian expert on the disease category to the medical, pharmaceutical and regulatory communities. You must have either of the following Academic qualifications; Pharmacist, Pharm.D., Ph.D or MD. Master's candidates may qualify depending on knowledge/experience and organizational fit.
 
Our client would prefer someone with experience in the therapeutic areas noted above. You would be willing to travel for training and congresses. Compensation is to 115K plus car, home office equipment and full benefits apply. This is a full time position with a world class company.

Location: Ontario, Alberta, or British Columbia

Call Herb at 416 225- 8071  for all the details mailto:hbotkin@sympatico.ca


  PHARMACIST to 100K, Montreal, Quebec

Since the inception of the human genome project, pharmaceutical and biotech companies have been developing new drug therapies at an accelerating pace, often without regard to the final cost which consumers will have to bear. Our client, one of the world's largest financial institutions, requires a state-of-the-art pharmacist who can understand the short-term and long-term therapeutic effects of these new wonder drugs and advise their actuarial staff on the cost implications of these products. Failure to provide adequate reserves for these very expensive drugs has left some insurers in very precarious circumstances and our client does not want to repeat the mistakes of the past. Yet at the same time our client has a fiduciary and moral responsibility to authorize life-saving medications. Consequently, we are searching for a seasoned pharmacy professional who is up to date on the latest therapies and can get a handle on new pipeline drugs that will be receiving Regulatory approval. The goal is to help streamline such approvals with respect to their pharmacoeconomic impact and determine which existing therapies have become redundant in light of the new stream of drugs that become available. Needless to say this position requires a pharmacist with exceptional negotiation and communication skills; someone who can work comfortably with Regulatory Bodies, Pharmacy Associations and the head office and field staff in our client company. The role also requires an understanding of "cognitive services" and how these can be applied to rationalize drug therapies. 
A licensed pharmacist with 5 years experience in a similar role or someone who has been in a role that dovetails this type of role would be the ideal candidate. Salary will be in the $80-$100K range depending on qualifications and experience. An industry leading employee benefits package is included. This is a full-time permanent position with a world class company.

Location:  Montreal, Quebec

Contact:Herb Botkin  416-225-8071 email: hbotkin@sympatico.ca


BIOSTATISTICIAN PhD, BIOSTATISTICIAN MASTERS, to $100K, Toronto, Ontario
 

The Intermediate Biostatistician will be a leader for statistical and data management projects, providing both leadership skills as well as technical expertise to the project teams. The incumbent will participate in developing clinical trial protocols, write Statistical Analysis Plans,

perform statistical analyses, and generate Statistical Reports. The Biostatistician will also oversee the development and implementation of data management and programming work plans, interact with internal and external clinical trial management personnel to jointly achieve clinical

trial objectives and timelines.

 

We require at least a Master's Degree (M.Sc.) in statistical and mathematical sciences or related fields plus two years relevant experience for this position. Ability to lead project teams, strong technical competence in statistics and SAS programming, as well as working level knowledge of data management are essential for the success of this position. Understanding of clinical drug development process and knowledge of FDA or Health Canada  regulatory requirements for new drug approvals as well as ICH/GCP would be preferred.

 

The Senior Biostatistician will require a Ph.D. with three years experience in clinical drug trials or a Master’s with six years experience in clinical drug trials.

 

Location: Toronto
Salary: $80-$100K, plus full benefits and bonuses.

Call Cris Murray 416 225-6386,  jedgar@sympatico.ca


 Sr. QC CALIBRATION CHEMIST, to $ 65K, Toronto, Ontario

We are currently searching for an experienced QC Calibration Chemist for one our our local Pharmaceutical clients in the GTA.  The ideal individual will be responsible for maintaining calibration status of all QC Lab equipment (HPLC, GC, IR, UV, TOC, etc). This will include: organizing and executing a calibration plan for existing and new equipment.  Reviewing/ updating / creating Calibration SOPs, reviewing current industry trends for our clients adherence to current practices and performing IQ/OQ on equipment installations.  The individual will also perform routine testing as required to assist QC in meeting its goals.
Must have a Bachelors of Science in Chemistry or equivalent, plus 3-5 years of Pharmaceutical industry experience.  Ability to operate HPLC,
GC and other lab equipment to perform calibration is essential to the success of this role. Assets for this post would be: Temperature mapping, qualification of equipment and validator experience with