Audubon PM Associate

• Sep 2022 - Present

Owner and Principal Consultant in Regulatory Medical Writing

• Sep 2022 - Present

Director, Head of Medical Writing R&D

• May 2019 - Aug 2022

• Lead and develop the Medical Writing group at R&D, including employees, internal and external consultants;• Ensure adequate resourcing, including recruitment of new employees and consultant solutions, to enable timely, high quality Medical Writing deliverables in line with the company´s priorities; • Provide mentoring, support and professional development to individual members of the Medical Writing group;• Manage performance and salary review processes for my direct reports;• Drive operational excellence initiatives; develop SOPs and other instruction documents.• Support highly prioritized projects with Medical Writing expertise. Show less

Senior Medical Writer

• Mar 2018 - Apr 2019

• Lead author of clinical regulatory documents such as Clinical Overviews, Clinical Summaries, briefing documents, regulatory responses;• Promote a label-focused, strategic and efficient way of developing clinical regulatory documents within the frames of the project work and operational excellence work at the department (e.g. workshops on high performance authoring); • Review of clinical study protocols and statistical analysis plans;• Contribute to the development of SOPs and other instruction documents. Show less

Management Coordinator (Ledningssamordnare)

• Nov 2015 - Mar 2018

• Coordinated the department's planning and follow-up, including handling of government assignments, risk analyses, action plans, tertiary follow-ups and annual accounts. • Collaborated with other departments to ensure a coordinated approach in planning and follow-up in the entire organisation.• Drove operational excellence initiatives within the department and the entire organization: lead vision planning workshops for the leadership team and co-workers, held talks on motivation and service design, and partook in the development project for the Board's management system. Show less

Projektledare (Project Manager)

• Mar 2014 - Oct 2015

• Drove the development of the National Guidelines for care in cases of depression and anxiety disorders. The guidelines are based on compilation and analysis of the current knowledge within the field and are used by decision-makers and professionals in the Swedish healthcare system;• The project organisation consisted of over 60 participants;• Maintained contact with relevant professional organisations, Swedish Association of Local Authorities and Regions, patient associations and other stakeholders;• Point of contact for media and general public inquiries. Show less

Medical Writer (contractor)

• Apr 2013 - Nov 2013

• Lead author of high-level clinical-regulatory documents that summarise the accumulated product knowledge and key drug development program conclusions; • Developed Clinical Overviews, Clinical Summaries of biopharmaceutic studies and Summaries of Clinical Safety for marketing authorization application; • Updated Investigator’s Brochure. • Lead author of high-level clinical-regulatory documents that summarise the accumulated product knowledge and key drug development program conclusions; • Developed Clinical Overviews, Clinical Summaries of biopharmaceutic studies and Summaries of Clinical Safety for marketing authorization application; • Updated Investigator’s Brochure.

Global Labelling Manager, Regulatory Affairs

• Jan 2012 - Apr 2013

• Team leader of a cross-functional international expert team driving the development of the drug label (Company Core Data Sheet, EU Summary of Product Characteristics (SmPC) and US Product Information (PI) for an emerging product; • Provided advice and support for the creation and maintenance of regional product information texts, ensuring strategic alignment with the global product information and other relevant project documents.

Medical Communication Scientist

• Sep 2005 - Dec 2011

• Team leader of cross-functional international clinical document delivery teams (consisting of statisticians, physicians, pharmacokineticists, programmers and other functions); responsible for leading and planning the work of these teams and delivery of the clinical regulatory documents to time and quality standards;• Lead author of clinical regulatory documents such as Investigator’s Brochure, Clinical Summary documents, Clinical Study Reports, General Investigational Plan, IND Annual Report, 90-days Safety Report, etc; • Contributed to strategic planning of future studies to ensure quality support for key program conclusions; ensure that a consistency and continuity of thinking and logic is present from program design to the eventual label of the drug;• Reviewed and provided advise on the clinical documents and other communications (e.g. Study Protocols, Clinical Study Reports, slide kits, Drug Project Strategy, and Clinical Development Plan), to ensure consistent messaging within a clinical program; • Provided support to external providers of clinical regulatory documents to ensure expectations on the delivery scope and standards were met, and to secure proper integration of information and alignment with the program’s key messages and standards;• International collaborations on the project and skill levels with Europe, US, and Japan. Show less

Research Scientist, Molecular Pharmacology

• Nov 2000 - Aug 2005

- Cloning, expression, and functional analysis of membrane protein activity in primary cell systems and Xenopus oocytes;- Screening of the functional activity of membrane proteins in automated systems (e.g. two-electrode voltage clamp (TEVC) recording in Roboocyte);- Cloned a novel cannabinoid receptor.