Job Description:
Septa Pharmaceuticals Inc. is proudly a Canadian owned and operated Pharmaceutical Company based in Ontario, Canada. Our mission is to provide quality pharmaceuticals and healthcare products to advance and nourish the quality of life in domestic and global markets. Our team embodies a group of diverse and talented individuals who work to achieve this mission while cultivating and participating in various community and environmental betterment initiatives.

We are currently in an expansion phase and are seeking qualified candidates to join our team. We are excited to announce the opening for a position of a National/International Sales Manager (Business Development). The incumbent will be charged with directing a group of inter and intra Pharmaceutical Sales Representatives with the overall objective of advancing the company’s product portfolio and achieving sales goals.

Essential Duties/Responsibilities:
• Grow available renewal base of customer accounts in line with revenue targets.
• Recruit, train, coach, manage, and evaluate performance of a team of motivated Sales Representatives to strengthen and establish current and additional sales opportunities ensuring development and optimization of their potential;
• Communicate regularly and continuously with their direct report by participating and conducting meetings on a monthly and quarterly basis or as required and directed.
• Schedule sales visits to provide appropriate coverage of defined accounts, to ensure promotion of current and future solutions are adequate.
• Participate in market development activities by identifying areas that are under-developed and to work with their direct lead to create a sound business plan to implement initiatives to increase market penetration and sales.
• Prepare and submit all pertinent reports accurately and on a timely basis as required.
• Establish a positive and challenging environment, while providing ongoing direction to ensure all regions’ success.
• Provide on-going evaluation of sales trends and rankings and identify the company ranking and adjust strategies accordingly to increase it.
• Participate in corporate personal, social, community, and environmental betterment initiatives with an overall objective of advancing and executing the company’s out-of-business efforts.
• 50-75% Travel within and outside Canada.
Qualifications :
• Bachelor of Science or Bachelor of Pharmacy Degree from an accredited university (MBA preferred)
• 5+ years of leadership and management experience with a solid experience in team building and talent recruitment.
• Proven track record of building, managing, and staying on budget.
• Strong customer service, interpersonal, presentation, written, communication, and organizational skills.
• Ability to work independently.
• Must have a valid Ontario driver’s license with a clean driving record.
• Proven passion, drive and, entrepreneurial disposition with solid skills in leading with encouragement & support.
• Strong follow-through; strong attention to details; strong negotiation skills; resourceful in resolving issues and troubleshooting questions and issues as they arise.
• Strong computer skills with proficiency in MS Excel, PowerPoint, Word, and Outlook.
• Fluency in French (both written, and spoken) an asset.

Job Types: Full-time

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Job Description
We work with major Pharmaceutical and Bio-Pharmaceutical CROs, Innovators and Generic Manufacturers globally to help source clinical trial supplies. Our extensive and global network of wholesalers and suppliers, quality-first attitude and 24/7 culture has made us into one of the most trusted companies in the field of Clinical Trial Supplies Sourcing.

Major Responsibilities
• Develops client leads and converts leads into fruitful business relationships.
• Develops and implements procurement plans and strategies and delivers results for value creation and cost savings.
• Leads supplier identification / selection and negotiations of MSA/SOW/RFPs with key suppliers for R&D projects and drives the team towards a timely decision with all risks identified.
• Ensures accurate reporting of Procurement key performance measures (operational metrics, savings, quality, customer service, etc.) for the category and tracks ROI.
• Builds and implements key enablers (tools, templates, systems, etc.) to raise team capabilities to deliver best-in-class support to business partners.
• Perform other related duties incidental to the work described.

QUALIFICATIONS
• Must have experience working with International Pharma Sales and/or CTMS sourcing and sales
• Must have experience working within a GMP, GDP environment
• Minimum 3 years of experience in Pharmaceutical sales. Clinical Trials sourcing experience is required. At least 3 years of relevant experience in strategic sourcing and procurement, of which at least 2 years of experience in clinical sourcing and other areas of global R&D sourcing is a must
• Minimum Bachelors Degree in Life Sciences, Pharmacy or equivalent
• In-depth strategic and operational procurement experience with knowledge of category management and advanced strategic sourcing methodologies is required with experience in running supplier performance management programs.
• A strong understanding of Regulatory landscape, Quality systems and procedures is preferred.
• Outstanding communication, consultative, and interpersonal skills with the ability to influence key stakeholders at all levels of the global organization.
• Strong problem-solving/solution and business acumen skills; must have outstanding ability to diagnose problems and to put in place actions/measures to address
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Strategic thinker with strong facilitation skills supported by excellent interpersonal competencies (communication, leadership, influencing).
• Solid sense of accountability, sound judgement, strong focus on quality and details.
• Experience working with partners at all levels, globally.
• Advanced skills with Microsoft Office Applications; Word, Excel, PowerPoint, and Outlook.

Job Types: Full-time, Contract, Permanent

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Job Description: Septa Pharma Inc., is proudly a Canadian owned and operated Pharmaceutical Company based in Mississauga, Ontario. Our Mission is to provide quality pharmaceutical and healthcare products to advance and nourish the quality of life in domestic and global markets.

We are excited to announce the opening for the position of Quality Assurance and Regulatory Affairs. Working to support operations and to ensure compliance as related to pharmaceutical products and regulations, the incumbent will principally be responsible for managing all Quality Assurance and Regulatory responsibilities as well as oversee the drafting and implementation of Standard Operating Procedures (SOPs) related to QMS.

The incumbent must have knowledge of Health Canada, DIN/NHP Guidelines, DEL requirements, Medical Devices, Clinical Trials, Knowledge of provincial formularies.

The Quality Assurance (QA) & Regulatory Affairs(RA) person will be responsible for all QA & RA functions including, but not limited to batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention as it relates to Drugs, Natural Health Products, Medical Devices and Cosmetics that are imported and/or distributed by the company in Canada and Globally.

• Conduct a review of and track Good Manufacturing Practices (GMP) documentation, including Master Batch Records, Master Packaging Records, Certificates of Analysis, Annual Product Quality Reviews, Stability, etc., for products imported and marketed.
• Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.
• Reviews production and laboratory records, assisting in internal audits and self-inspections.
• Supports in the development of SOPs to ensure efficient and compliant Quality function.
• Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
• Ensure that all medical device, drug, natural health product and cosmetic products released is of intact product integrity.
• Liaise with the suppliers of medical device and/or drug and/or natural health and/or cosmetic products.
• Liaise with third party Quality and Regulatory Designate.
• Keep an up-to-date knowledge on company and Health Canada regulations and policies applying appropriate implementation strategies where required.
• Reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.
• Supports all quality related exportation requirements as a QPIC (Qualified person in charge)

Minimum Requirements:

• Minimum Bachelors Degree (Canadian Equivalent) in Science, Pharmacy, Pharmaceutical Science. Preference will be given to candidates with Masters or PhD degrees.
• 5+ Years of experience in compliance, quality assurance, regulatory affairs, and document management in the pharmaceutical or prescription drug industry or equivalent
• Must have led Health Canada Audits
• Experience in an environment adhering to federal governmental regulation (Health Canada / USFDA) is required
• Strong GMP pharma/ Qualified Person in Charge (QPIC) experience is required
• Prior experience interacting with auditors and regulators is required
• Experience in document control and management is required
• Experience with preparing regulatory submissions is required
• Knowledge of ANDS submissions is preferred
• Knowledge of NHP submissions is a must

Job Types: Full-time, Contract, Permanent

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