bodil wallin

Authorship and coordination of development of regulatory documents and other clinical documents, including briefing documents, pediatric investigational plans and clinical parts of applications for marketing authorisation (e.g. Biologic License Application). Other duties included development of structure and processes within medical writing.

Duties included leadership of all clinical activities for candidate drugs within a target of analgesia up to Phase IIb, extensive cross-functional project work, identification of risk and opportunities and consultation and decision processes. The work included authorship and coordination of clinical development plans, program feasibility and cost and timeline templates for clinical programs.

As acting Study Delivery Director of the clinical neuroscience project team duties included operational feasibility, patient recruitment, leading and supporting program and team leaders and delivery of the clinical study program for a target from study outline to data base lock. The disease areas were Parkinson’s disease, multiple sclerosis and analgesia (small molecules and biologics). Duties also included delivery of regulatory documents and other clinical documents on all levels (study, target and disease area).

As Study Delivery Program Leader within a PD program, duties included strategic clinical work, cross functional project work as well as responsibility for clinical study delivery team leaders and delivery of the clinical study program. Duties also included authorship, co-ordination and review of regulatory documents and other clinical documents on study-, program- (i.e., target) and project level (i.e., disease area).

Development of regulatory documents and other clinical documents for analgesic, neurologic, neuroprotective and cardiovascular compounds, as well as for medical devices within neuroprotection and urology. The main role was medical writing of regulatory documents in Phase I, II and III as well as methodological studies. The work also included clinical project team work and pharmacokinetics (clinical and toxicopharmacokinetic) and project leader roles. Other duties included regulatory items such as producing and updating product information documents in fass.se (data base for authorised medicinal products in Sweden).

As Clinical Research Manager in both single centre and multicentre clinical studies in analgesia, duties included leadership and responsibility of clinical studies, from plan to study closure, in co-operation with other skills and departments as well as liaising with external contacts and outsourcing of parts of study deliveries. A key item was authorship and co-ordination of regulatory documents and other clinical documents.

Duties included biochemical pharmacology related work, such as development of analytical methodology, using techniques as HPLC, radiometry, electrochemistry, spectrophotometer and fluorescence. It also included experimental work related to research and development of drugs to treat stroke, Alzheimer's disease and other neurodegenerative disorders. Duties also included planning of studies in co-operation with colleagues in other departments and disciplines and liaising with external scientists and academic groups.

The work included development and translation of regulatory documents and other clinical documents for medicinal products and medical devices, such as risk management plans and clinical evaluation reports.

Part-time work at the pharmacy Vasen.

Clinical assessment of different types of applications in various processes such as new applications, extensions, variations, renewals, periodic safety updates and scientific advices for drugs within infections. Other duties are writing monographs, disclosure of official documents, assessments of drug names, secretary of the scentific council at the MPA and vaccine coordinator.

Different practical training periods in Turkey including practice at the Drug Control Section of Central Institute of Hygien in Ankara, School of Health in Ankara, department of Pharmaceutics at University of Istanbul and pharmacy Rebul Eczane ve Optic in Istanbul.