• Part of the GCD leadership team.

• Ensuring effective allocation of medical writing resources to projects and tasks.

• Responsible for managing, coaching and developing the team of Medical Writers – hereunder:

      o Yearly appraisal/performance goals.

      o In collaboration with the employees, planning of their training         (courses and congresses).

      o Ensuring personnel files are maintained and updated.

• Participating in publication teams and supporting planning of publication plans.

• Participating in PubRC activities, and when needed, giving input to publications prepared by investigators and CROs.

• Ensuring continued collaboration across functional areas.

• Taking overall leadership of various medical writing activities:

      o Integrated Clinical Trial Report:

            o Driving and preparing Clinical Trial Reports

               (ICTR).

            o Reviewing of the Statistical Analysis Plan (SAP).

            o Ensuring effective collaboration with CRO's with respect        

                to preparation and review of outsourced ICTR's.

      o Clinical regulatory documents:

            o Driving and preparing clinical summary documentation      

                i.e. Clinical Summary, Clinical Overview, PIP’s, briefing 

                documents and otherdocuments used for regulatory

                submissions, other communication with regulatory 

                authorities and other documents/communication to be 

                used for regulatory purposes.

            o Ensuring consistency between ICTR’s and the final 

               documents.

      o Investigator’s Brochure (IB) and Investigational Medicinal Product 

         Dossier (IMPD):

            o Driving and preparing/updating the IB and sections of the 

                IMPD.

            o Ensuring consistency between the various clinical documents, 

                the IB and the IMPD.

      o Quality Control (QC):

            o Contributing to ensuring timely QC of all relevant mentioned 

                documents prepared by a Medical Writer, Principal Medical 

                Writer or a Senior Medical Writer employee.

      o SOPs:

            o Ensuring that updated SOPs related to Medical Writing e.g.,       

                ICTR and IB SOPs are in place.

            o Contributing to training of Medical Writers, Principal Medical 

                Writers and Senior Medical Writers in these SOPs.

            o Informing other relevant functions in-/outside GCD about the 

                SOPs.

      o High-priority documents with clinical relevance:

            o Preparing misc. high-priority documents in collaboration with 

                internal and external stakeholders/customers, input to stock 

                exchange messages, input to press releases etc.

• Sharing of relevant knowledge within GCD and other of our client's stakeholders.

• Coordinating and ensuring public disclosure activities for

clinical trials at our client's company.