Job Description

Role Description

This position provides strategic administrative support to the Vice President, Scientific Affairs and the Scientific Affairs, Regulatory and Quality departments. The Executive Assistant position is integral to the day to day operations of the department, supporting and managing operational processes, and creating a streamlined environment where the management team can successfully execute/implement the LEO strategic plan.

Responsibilities:

Administrative Support to Vice President

Provide the VP with ad hoc administrative and project support as required

Administrative support to Department

Maintain department filing, databases and team calendar, including vacation tracking

Draft e-mails, letters, memos, reports etc. for internal and external stakeholders; prepare mass mailings and couriers.

Distribute mail and answer incoming common inquiry phone calls and emails

Department Super-User for LEO software (e.g. eQuality); ensures all department related content is updated and relevant; proactively ensures completion of required processes and training proactively and as notified of outstanding matters

Provides administrative support to Scientific Affairs Leadership Team, Grants, Donations & Sponsorship Team department, including but not limited to the following: scheduling, attending and taking minutes at department meetings, ordering office supplies,

Prepare, process and reconcile expenses against department activity tracker; prepare cheque requisitions

Manage Purchase Order process for department and maintain related backup files for department budget tracking in compliance with policy and SOP\'s. This involves: creating the purchase order, ensuring electronic approval, communicate PO number to external vendor for invoicing purposes, ensuring contracts are signed for each purchase order request, entering contract into electronic contract database

Arrange/coordinate meetings/conferences as required with external and internal customers including travel, hotel, catering and audiovisual

Assist with onboarding of new hire and returning employees, including office set up, providing department specific materials for new hire package to HR for inclusion in new hire package, updating department records, etc.

Perform other miscellaneous requests and projects as required.

Department Specific

Provide administrative and operational support to the Medical Affairs, Medical Information & Pharmacovigilance, Compliance, Regulatory and Quality Departments.

Collaborate with the Scientific Affairs, Regulatory and Quality Teams in order to update and maintain the Scientific Affairs Sharepoint including maintaining and updated list of documents (organizing, uploading, destroying or archiving new, critical or expired documents), in order to meet Health Canada, IMC and PAAB regulations and internal SOPs.

Working closely with finance, Medical Affairs team and VP Scientific Affairs provide OPEX administrative support to process SOWs, invoices, phasing, accruals and maintain and updated department budget to ensure good financial practices.

Consolidate field Medical Affairs and MSL budgets; Follow up with MSLs for spend within their specific territory and consolidate spends and/or reallocate funds as necessary.

Assist in the organization of Departmental Meetings, Scientific Affairs Town Halls, MSL meetings, Journal Clubs and Scientific Trainings

Coordinate and lead the Scientific Affairs Leadership Team meetings and assist with scheduling, agenda preparation, minute taking, preparation of reports and follow up with team members or individuals with deliverables as required

Collaborate and lead all SA team meetings (including registry, research, clinical team, regional, launch, training and offsite meetings) as required with internal and external stakeholders including tasks such as research, budget, logistics, catering, preparing meeting agenda materials, travel (at times), etc.

Assist RA with yearly Health Canada meeting ie; logistics, travel, agenda, coordination and communication, printing of materials, HCP agreement (if required), etc.

Assist RA and QA with documentation and archiving as per Health Canada requirements and LEO SOPs to maintain audit readiness and provide administrative support as necessary

Coordinate and lead the Grants, Donations & Sponsorship Team meetings and assist with scheduling, agenda preparation, minute taking, preparation of reports and follow up with team members or individuals with deliverables as required

Work closely with Medical Managers and MSLs as required, to manage vendor related payments, Compassionate Use Program, and activities with HCPs (including educational programs: CMEs, OLAs conference symposia; advisory boards; regional consult meetings; preceptorships; and publication related activities: guidelines, research articles, scientific supplements slide decks etc.) Also assist with meeting coordination, follow up, collect and file contracts, complete HCP vetting and vendor set up and payment processing, processing invoices and create Purchase Orders.

Coordinate and oversee HCP qualification process. Support Medical affairs team to gather necessary documents to tier HCPs appropriately as well as identify and correct any expired HCP tiering to ensure seamless HCP engagement.

Assist with HCP engagement, and agreement processing in compliance with SOPs and LEO Policy, including; creating, distributing and tracking agreements, arranging travel, and ensuring HCP\'s are paid for services.

Management and admin support of the LEO HCP interaction log - 6 step business need process for LEO

Ongoing Audit Readiness support for RA/QA/C/MIPV - where required

Support Compliance team with internal and external audit preparation, following up on CAPAs with various departments, tracking action items/resolutions

Support PV with the administrative management of CIOMS forms

Coordinate and support Special access program with Health Canada. Collaborate with VP, Scientific Affairs and Medical Information Manager to ensure proper documentation, approval and the release of SAP or CUP product

Management of archiving documentation as required.

Tracking and Admin Support to manage and streamline the process of GDS for LEO within Scientific Affairs

Operational Scope & Responsibilities

Support and enhance operational processes within the Medical Department in order to ensure efficient and compliant execution.

Provide administrative and operational support to the Medical Affairs, Medical Information & Pharmacovigilance, Compliance, Regulatory and Quality Departments.

Serve as SA operations representative on the Scientific Affairs Leadership Team and provide advice and operational perspective to help implement solutions, achieve efficiencies and increase collaboration.

Maintain overview of all active IIS, NIS and CSU studies with milestones and budgets. Ensure in collaboration with Medical Manager that all status, milestone and financial information for active studies is tabulated and up to date

Collaborate with MSLs and Medical Managers to update and maintain list of clinical research sites with practice size, focus and research infrastructure and capability captured

Work closely with Medical managers and MSL team on education activities to gather evaluations and feedback. Maintain an ongoing document of feedback and ensure any critical feedback or unmet needs are identified and captured in needs assessment.

Assist in the yearly preparation of the upload file of the Transfer of Value to HCPs list, Third Party certification process for vendors and receivers of Grants, Donations & Sponsorships

Work with Compliance to ensure Medical Department is adequately trained on SOPs/policies, Review trainings matrix at regular intervals and update current positions and SOPs/policies to be trained and roll-out of (re)training of (updated) SOPs/policies.

Incumbent Specific

Act as a Fire Warden for LEO

Worker Representative on the corporate Joint Health and Safety committee

General

Ensure compliance with appropriate SOP\'s, policies and guidelines.

Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP\'s, guidances are issued.

Participate in personal development and training sessions as required for the position.

Work in a safe manner that does not endanger yourself or co-workers. Report any health or safety concerns (internal and external) in compliance with LEO policy and standard procedures.

Strive to consistently uphold LEO Pharma\'s core values.

Execute other duties as may be required by Executive team members and other members of LEO Pharma\'s Management team as training and experience allow

Qualifications:

5 to 7 years demonstrated experience providing senior level administrative support

Ability to act with a high level of integrity and confidentiality

College Degree in Business Administration or related discipline is an asset

Exceptional written and verbal communication skills

Superior computer skills with Lotus Notes, Microsoft Word, Excel, and PowerPoint in a Windows environment

Experience in a Scientific Affairs environment is an asset

Knowledge of medical terminology is an asset

Bilingual skills are a definite asset Business Insights

Knowledge of pharmaceutical industry is preferred

Behavioural Competencies

Customer Focus

Instills Trust

Drive for Results

Action Oriented

Nimble Learning

Courage

Communicates Effectively

Business Insights

Collaborates

Resilient

Adaptable

Flexible

Leo Pharma