Regulatory Affairs Project Manager and Medical Writer @ ELC Group Limited is a leading global services organization that helps clients expedite time-to-market through our services.
Over the past years, ELC group has developed significant expertise to assist clients with the development and launch of their products.
Our mission is to combine the strength of our expertise, experience and innovation. Our goal is to deliver for our clients: on time, and on budget - every time.
Specialties: ELC group delivers its customized clinical, sales, marketing and communications solutions through its four core business segments:
• Global Regulatory Affairs
• New Drug innovations and medicinal products
• Medical devices
• REACH
• Corporate languages solutions
Project Management Activities:
Supervising and coordinating multiple projects, covering all activities related to the development, production, registration and marketing of medicinal products and medical devices, both in the EU and other regions.
Coordinating and cooperating with other departments (business development, RT, translation and artwork department) to ensure that projects run smoothly and deadlines are met.
Regulatory Affairs Activities:
Working closely with government health agencies to ensure all legislation is closely followed and the client’s products comply with the regulations.
Submitting registration documents to regulatory agencies, and carry out all the subsequent negotiations and activities necessary to obtain and maintain the marketing authorization for the products.
Preparing and revising regulatory documentation to ensure it is compliant with the relevant legislation From December 2014 to Present (1 year 1 month) Cambridge, United KingdomWard Manager @ As a ward manager I was responsible for managing the administrative functions of my allocated hospital ward.
Responsibilities:
- Ordering medical supplies
- Tracking expenses
- Enforcing standard ward policies and procedures and training and recruiting ward staff.
- Conducted audits
- Monitor catering, cleaning and laundry services
- Investigate and record accidents and complaints
My main responsibility was for the management of the nursing and health care assistant team.
• To lead, co-ordinate and support a multi-professional ward based team
• To work closely with the practising nurse team as well as healthcare assistants
• Work alongside other managers to help identify areas of clinical development
• Demonstrate an in-depth knowledge of the options for achieving control of symptoms
• Take a leadership role in the discussion of legal, ethical and professional nursing
issues within the team
• Independently assess the patient’s needs, identify their goals and work with the
patient family towards achieving them
• Recognise the clinical burden on the team and take action to manage it
• Demonstrate negotiation and diplomacy skills and partnership working with external
agencies
• Demonstrate competency for managing specific nursing tasks e.g. epidural,
venepuncture,
• Giving IV drugs, and assisting doctors with drug preparation From January 2011 to Present (5 years) Receptionist and HR Assistant @ The Mercedes Benz AMG Receptionist is the first person to greet visitors both telephonically and in-person in the organisation.
The role entailed answering a multi-line telephone system, greeting visitors in a timely manner, as well as providing information and assistance to other departments.
Additionally, my role consisted of assisting with the recruitment side of the organisation, uploading vacancies and writing up weekly reports for the AMG Petronas team members, keeping them up to date with coming track races and events such a and visitor appointments, including international F1 members including Nicky Lauda as well as key engineering personnel.
My role also involved responding to daily fan mail and letters, as well as arranging job interviews for specific managers within each department and booking them into the system and finally sending out verbal and paper confirmation of the agreed interview times.
This fantastic opportunity enhanced my passion within the Formula One industry, where I got to see the engineering behind the supercars and got to meet their 2 race drivers Lewis Hamilton and Nico Rosberg. From June 2013 to November 2013 (6 months)
Medical Physiology @ The University of Leicester From 2009 to 2013 University of Leicester From 2009 to 2013 Minelli Torosyan is skilled in: Customer Service, Microsoft Word, Research, Microsoft Office, Medicine, Laboratory, Management, Patient Safety, Healthcare, Teamwork, Data Analysis, Time Management, Clinical Research, Forward Thinking, Public Speaking