Member of Medical Affairs Department, providing high quality scientific and clinical support to medico-marketing activities and to the field based teams (where appropriate) to support the Germany Regional Commercial Unit (RCU). To build and maintain relationships with key external stakeholders as well as help manage any clinical research conducted or supported by Norgine.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Be the medical expert for Norgine therapy areas and a permanent member in the respective local brand teams inputting into the strategy for the brand
- Support medical and product training activities for Norgine employees
- Support the Medical Director in carrying out the day to day operational activities of the Medical Department.
- Support and deputise the Medical Director in scientific lead activities, e.g. and not limited to Copy Approval, evaluation and processing of Investigator Initiated Studies, Transparency etc.
- Provide input to Norgine Global projects as agreed from time to time on a defined basis.
- Work to ensure compliance in all Norgine Germany’s procedures including GxP, Codes of Practice and medicines legislation.
- Support medical affairs projects and activities
- Maintain high standards of technical proficiency
- Develop relationships with Key opinion leaders, patient organisations and professional groups
- Ensure continuous update of medical and product training material
- MAIN TASKS:
Medical contribution to brand team
- Leverage clinical/scientific data to optimise the delivery of Norgine Germany brand plans.
- Lead development of Medical brand plans for relevant Norgine products
- Collaborate with Senior Medical Information and Compliance Manager and with MSLs in order to be the primary “data experts”for Norgine therapy areas
- Understand current and future positioning aims for the brands and identifyscientific activities that support the achievement of those aims.
- Identify and communicate new published data as appropriate
- Monitor key information sources of changes within the pharmaceutical industry, NHS and healthcare which may impact on Norgine products and communicate of relevance to the brand team
- Proactively identify needs for promotional/ non-promotional material and discuss with marketing colleagues
- Offer OL insights to support medical and scientific strategy and communications
- Through expert knowledge of the scientific data and using clinical experience and knowledge, support the development of clinical arguments for HTA submissions if required
- Review of promotional/ non-promotional material to ensure scientific correctness of content as well as compliance with the applicable law and Codes of PracticeSign off promotional and other material in line with the Company certification procedure as scientific lead, if required.Support the Medical Director and the Senior Medical Information and Compliance Manager with compilation of effective complaints against competitor promotional campaigns and defence of complaints against Norgine Brands claims as appropriate
External stakeholder relationships
- In collaboration with MLSs and Senior Medical Information and Compliance Manager establish and develop strong relationships with key external customers including KOLs/ professional groups in relevant therapeutic area, in order to gain insights to support sound decision making and brand strategy development.
- Identify opportunities for collaborative work, such as research, guideline development, meeting presentations etc.
- Make scientific and clinical presentations to customers in primary and secondary care either on request or proactively as part of a broader medical education strategy
- Provide accurate and non-promotional scientific information relating to licensed and unlicensed products and indications following unsolicited requests from HCPs
- Develop relationships with patient groups and third party organisations to facilitate the exchange of scientific and clinical information around Norgine products and raise awareness of relevant disease areas .
Medical Affairs activities
- Support the development of medical affairs projects & publications plans
- Support the internal project management of IISs, providing study progress follow-up and support as required
- Develop and maintain guidelines and procedures e.g. internal SOPs as directed by the Medical Director
- Provide medical input and strategic input into advisory boards, engaging with clinical advisors on a peer to peer level, in collaboration with MSLs
- Engage in medical information activities, answer medical enquiries in collaboration with medical team
- Facilitate communication between Norgine and those healthcare professionals who wish to carry out local trials/assessments of our licensed products.
- Act as deputy to the Germany Medical Director in his/her absence as required
- Act as deputy to the Information Officer (legal function) in his/her absence as required
Medical support for field based teams
- Provide high quality and timely briefing materials/training to sales-force, MSLs or Market access, on relevant appropriate data.
- Support MSL team with regular updates of MSL slide decks
- Research, construct and write scientific materials to support the sales force, Market Access, Regulatory Affairs or others as required
- Develop an maintain in-depth knowledge of disease areas and their management of relevant company products
- Develop and maintain in-depth knowledge of the company’s products, the relevant therapeutic area, the medical device regulation and the structure and workings of the German Health System.
- Attend relevant training courses, and apply to daily tasks using agreed action plans, coaching and knowledge
- Provide internal training and specialist support on Brand / Therapy Area as required.
- All relevant local and global Norgine departments
- External stakeholders: including regulatory bodies, patients and patients’ organisations, Health Care Organisations, customers
- Medically qualified (MD) and holding full authorisation (Approbation)
- Fluent in German and English
- More than 2 years clinical experience and experience beyond clinical medicine preferred
- Working knowledge of the Healthcare System and of the research procedures as well as GCP and other ethical guidelines relevant to the pharmaceutical industry, e.g. relevant Codes for medicinal products and medical devices.
- Good understanding of the clinical trial process and research infrastructure in Germany
- Ability to understand, process, communicate and present scientific information to a high standard
- Proven ability to use IT tools and interface effectively with a variety of technical platforms
- Strong personal integrity, and customer focus.
- Excellent interpersonal communication, negotiation and advanced presentation skills.
- Analysis and Problem solving skills
- Able to effectively contribute and work on multifunctional teams.
- Must be able to adapt, organise, prioritise, and work effectively in a constantly changing field-based environment.