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Sydney Permanent Posted: Thursday, 16 May 2019

Company in the Research sector.

  • Be actively involved in the recruitment, development and training of direct reports
  • Coach and counsel all direct reports in an appropriate and timely manner
  • Ensure compliance with global and local, external and internal regulations, standards, policies and SOPs
  • Collect, assess and share on a "need to know basis" competitive intelligence information
  • Ensure healthcare professionals and decision makers receive accurate, unbiased, balanced, and timely answers to requests for information about our products
  • Establish and manage scientific/clinical relations with KTL locally and identify emerging local KTLs
  • Oversee the planning, execution and tracking of medical affairs activities:
    Clinical studies (including ISTs), clinical study reports, publications/scientific communication, advisory boards, congresses, KTL activities, education (internal & external), promotional material (creation, review, approval), medical information support
  • Provide the planning and leadership to the Medical department by ensuring that appropriate structures, systems, competencies and values are developed.
  • Responsible for the financial management of the R&D program, including budget planning and resource allocation.
  • Provide leadership and medical expertise in the development of clinical trial programs (in line with global strategy) to support product registration and bridge scientific data gaps locally.
  • Provide medical and scientific input to global product development and medical affairs teams
  • Provide support to local business development activities like assessment of therapeutic fit and scientific evaluation for identified local new products
  • Act as a medical resource to the company as a whole and particularly to the clinical research (protocol and CRF writing, adverse events, discussions with investigators, and internal meetings).
  • Collaborate with the LDSO regarding the reports of adverse events related to assigned products
  • Collaborate in labeling actions with Regulatory, Market Access and Corporate Affairs Area.
  • Work within company Standard Operating Procedures, industry guidelines (Medicines Australia & RMI) and apply Serono Values and Code of Conduct in daily duties activities.
  • Medical doctor with a post graduate qualification preferred ( Physician, Specialist in Internal Medicine, Oncology or Neurology preferred)
  • Experience in managing teams
  • Training in regional/local and international regulations including Good Clinical Practice
  • More than 8 years experience in the pharmaceutical industry (Clinical Development/Medical Affairs/Commercial Operations)
  • Prior industry experience as Medical Manager
  • Knowledge and experience in project management

Sydney, Australia
EMD Serono
EMD Serono
16/05/2019 10:49:00 AM

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