Experience

Caudex

• Norway
• Strategic Management Services

• Account Director

  • Oct 2017 - Present



McCann Complete Medical Canada Ltd

• Canada
• Wellness and Fitness Services

• Account Director

  • 2017 - Present



Inceptus Media

• Sweden

• VP Medical Communications

  • Apr 2013 - Present

  • Intimately involved in development of new medical education platform, AMEDEA MD™ (iPad app and online)• Supervise medical content• Work with subject matter experts (physicians and allied healthcare professionals) to coordinate content (including review and editing of content)• PAAB submissions related to iPad applications containing e-detailing content• Business development, sales and account management (research new business potentials and meetings with potential and current clients)• Write and negotiate proposals and contracts (e.g. master agreements with clients)• Manage project coordinators and liaise with client during the production of each program• Work closely with the president in management of the company, including financials, invoicing and project budget tracking



CD Pharma

• Pharmaceuticals

• General Manager/Senior Account Director

  • Jul 2007 - Apr 2013

  • Management of overall operations• Supervise new product development• Hiring of new employees• Oversee company financials and invoicing• Business development/sales for educational program, Interactive Lecture Series™• Research new business potentials and meetings with potential clients• Manage project coordinators and liaise with client during the production of each program• Correspondence with physicians and medical writing/revision of content provided by physicians for the programs



Seryx

• Canada
• Biotechnology Research

• Senior Scientific R&D Executive

  • 2005 - 2006

  • PubMed searches; critically evaluate clinical studies and write literature summaries for product development.• Input summaries into database/expert system as well as update expert system parameters.• Physician liaison for report interpretation.• Prepare and give presentations to prospective customers and collaborators and at scientific meetings (e.g. American Association for Clinical Chemistry [AACC]).• Involved in FDA negotiations for medical device pre-market approval application.• Reviewer, NACB (National Academy of Clinical Biochemistry) Laboratory Medicine Practice Guidelines (LMPG) on Pharmacogenetic Interpretive Reporting.



Paladin Labs

• Canada
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Scientific Affairs Associate

  • 2001 - 2004

  • Clinical drug development: project management/liaison between Paladin and contract research organizations for clinical trials; involved in preparation of Clinical Trial Application (CTA) and subsequent CTA amendments; coordinate trial master file and study audit; coordinate manufacturing of pharmaceutical formulations of a drug to be used in clinical trials; coordinate phase I and III protocol development with CROs and key opinion leaders; phase IV study evaluating patient satisfaction with drug.• Coordinate analytical method validation/transfer; manage release testing and stability studies for clinical drug product.• Regulatory affairs: post-marketing submissions (administrative and responses to deficiencies); orphan status submissions (FDA & EMEA); NHPD product licence application; collect adverse drug reaction reports; preparation of pre-NDS meeting package, attend pre-NDS meeting, correspond with Health Canada officials.• Prepare and submit small biotechnology business grant application to NIH (US).• Collect process and test method validation documents from manufacturers of Paladin products.• Participate in budget planning.