Job expirat
- To provide strategic and operational direction of the existing investigator-sponsored, as well as scientific guidance and oversight of publications, medical information, medical education, drug safety, and the field-based scientific affairs managers; Contact scientific societies and opinion leaders;
- To focus on the post-marketing development and medical affairs support of pharmaceutical products. Partner with the marketing department to optimize the post-marketing strategic development; Review and approve promotional and non-promotional materials (printed and audiovisual), local packaging development;
- Working closely with clinical development, sales/marketing and key opinion leaders you will conduct studies to support the life cycle of novel drugs post-launch - phase IIIb/IV. Conduct international and regional multicenter phase III and IV studies, ensuring start, end recruitment and study complete in line with the international time frame;
- Manage all Registration activities (new submissions, prolongations, variations);
- New Drugs evaluation & clinical development (clinical trials), Regulatory support, clinical documentation for the group's pharma products; active participation (in cooperation with Medical Director) in regulatory issues management;
- To registrate all products to the authorities and to assure that they meet all the legislations of the country;
- Review technical documents and approve labeling and promotional/advertising materials as directed by the Management;
- Plan and prepare regulatory submissions (Annual Reports, Periodic Safety Update Reports);
- Assist in the development and implementation of Standard Operating Procedures for various critical activities within the company;
- Receive and respond to product complaints, and assist in the maintenance of product complaint files. Prepare incident reports and alert reports/notifications as needed;
- Read, review, interpret and keep current with regulations and publications regarding drug products to provide technical assistance and direction to the other functional groups;
- Provide clinical and scientific direction, review, and approval of all medical communications, including medical information, publications, drug safety submissions, publications, marketing materials, etc;
- Maintain national and international visibility for the Company through frequent, effective presentations to investigators, potential collaborators, corporate partners, medical groups, and senior management;
- Participate in medical background training for medical representatives;
- Plan and budget for clinical studies
- Assess and select sites and investigators to conduct studies according to the company¿s SOP and GCP standards, with the help of CRA & marketing;
- Participate in the pre-launch activities for the new products and scientific promotions.
- Qualified MD (degree) with solid knowledge (5-15 years) in the pharmaceutrical industry in the field of Medical Affairs including Clinical Studies and Drug Safety;
- Experience in a reputed Pharmaceutical unit with hands down knowledge of Clinical Trails;
- Ability to create innovative solutions to achieve business goals
- Strong communication and interpersonal skills dealing with various cultures
- Previous practical experience in medical product regulatory activities, and general knowledge of pharmacutical regulations in the post approval drug area;
Preference for experience in Advertising and Promotion of regulated products;
- Strong experience in the management of clinical and or medical affairs professionals and knowledge of several other key development disciplines (e.g. clinical research, health outcomes research, pharmaco economics, regulatory affairs, and/or marketing);
- Good working knowledge of current quality, regulatory and clinical requirements of the pharmaceutical industry as well as excellent presentation skills for audiences that may include physician thought leaders, community clinicians, and/or corporate partners;
- High integrity and strategic ability;
- Self-confident, proactive, highly interactive, and decisive leader who will facilitate the best possible execution of projects;
- Good communication style and reputation which inspires;
- Strong record of accomplishments and peer recognition in previous leadership positions;
- Excellent English skills.
ISG Romania (www.isg.org.ro; www.romaniajobs.ro) is a Romanian-Austrian joint venture company present on the Romanian market since 1999. Now it is part of one of the most important European recruitment network - International Service Group (www.internationalservicegroup.com), and has partners in over 22 countries.