Junior Regulatory Affairs Specialist (Medical Devices)

Main responsibilities:

  • Analysis and preparation of documents for registration of medical device, the formation of the application clarifying the completeness of the register of medical devices;
  • Preparation of the necessary documentation;
  • Interaction with contract organizations (testing laboratories accredited, consulting company);
  • Tracking and analysis of current changes in legislation.

Requirements:

  • University degree (biomedical, biological, chemical, physical, medical, pharmaceutical, technical);
  • Experience in a similar position would be an advantage;
  • English – Intermediate.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Junior Regulatory Affairs Specialist (Drugs)

Main responsibilities:

  • Preparation and formulation dossiers for registration, the full cycle (preparing the local dossier, layouts, packaging, instructions for use and ND in accordance with corporate requirements (subject to the requirements of local legislation));
  • Submission of registration dossier to the relevant authorities, the traceability of the registration procedure, preparation of responses to requests of the competent authorities, obtaining of registration documents;
  • Support of process of registration and changes in registration documents;
  • Interaction with regulatory authorities of the Russian Federation;
  • Timely notification of enterprise registration Department and local divisions of the company about the submission and receipt of registration documents;
  • Tracking and analysis of changes of the current legislation in terms of circulation of medicines;
  • Review promotional materials in terms of compliance to regulatory requirements;
  • Interact with various organizations providing services in the field of registration and Declaration of products.

Requirements:

  • Higher pharmaceutical/ chemical education;
  • English – Intermediate;
  • Experience within a pharmaceutical company would be an advantage;
  • Knowledge of the legislation of the Russian Federation in the field of drug registration.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Pharmacovigilance Manager

Main responsibilities:

  • Qualified PV coverage and processes for back-up coverage (including coverage outside of business hours);
  • PV training of the Affiliate staff;
  • PV business continuity planning and notification of any incidents that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance;
  • Prompt and direct notification of GPV/ QPPV of any PV related items;
  • Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities;
  • Handling of internal PV audits and inspections from regulatory authorities;
  • Affiliate Individual Case Safety Report management (that is, receipt, documentation, forwarding to GPV, tracking, expedited reporting, etc);
  • Collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials);
  • Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes;
  • Local screening of scientific literature and social media for safety information;
  • Periodic safety reporting (that is, collaboration with EPD GPV regarding scheduling, local submissions, etc.; if applicable, generation of periodic safety reports themselves);
  • Handling of inquiries relating to product safety including regulatory authority inquiries;
  • Handling of safety information arising from product complaints;
  • If applicable, local implementation and tracking of RMP activities resulting from global RMPs;
  • Contribution to product labeling changes;
  • Record retention.

Requirements:

  • Intermediate/ Upper-intermediate in English;
  • University degree in Medicine or Pharmacy;
  • External Pharmacovigilance postgraduate degree/ trainings;
  • Result-oriented, flexibility, problem-solving, ability to work efficiently under pressure of time and circumstances.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Junior pharmacovigilance specialist

Main responsibilities:

  • Process spontaneous and solicited/ clinical trial adverse events reports and enter them into the Global Safety database;
  • Request appropriate follow-up information;
  • Submit spontaneous and solicited/ clinical trial individual case safety reports to the Local Health Authority;
  • Process all cases within specified timelines;
  • File, store and archive safety-related data.

 Requirements:

  • Higher Education –Medical or pharmaceutical is preferable;
  • English –Intermediate/ Upper-intermediate level required;
  • Learning, accuracy in details.

 We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Junior Quality Assurance Specialist

Responsibilities:

  • Support quality related customer complaint investigations and trending activities;
  • Working with global procedures and SOPs;
  • Support the development and implementation of improved quality reporting measures;
  • Perform training in all aspects of Quality Management Systems.

Requirements:

  • Higher Education –Medical/ pharmaceutical/ biological/ chemical/ biotechnological/ chemical engineering;
  • English–Intermediate/ Upper-intermediate level required;
  • Learning, accuracy in details.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Service Engineer

Main responsibilities:

  • Normally receives no instruction on routine work; general instructions on new assignments;
  • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained;
  • Provides quality assurance for adherence to technical standards;
  • Adheres to policies and procedures;
  • Provides daily oversight and direction to work unit;
  • Supervises two or more direct reports;
  • Hiring, firing, and disciplinary authority;
  • Performs less than 50% "hands-on" work;
  • Resolves routine issues; identifies non-routine issues and may take actions to resolve;
  • Informs necessary individuals on status of work and decisions;
  • Solicits input from others and includes them in the decision-making process when other people or processes will be affected;
  • Prepares for technical or managerial advancement;
  • Seeks innovative ways to accomplish objectives;
  • Continuously learns from experiences, particularly non-routine challenges;
  • Seeks feedback from others to improve skills;
  • Develops supervisory and leadership skills;
  • Focuses on key tasks when faced with limited time and resources;
  • Quickly identifies projects and initiatives requiring special attention;
  • Accountable for achieving daily, weekly, monthly and annual work unit objectives. Allocates resources and provides direction. May also have budget responsibility;
  • Serves as a positive role model to others by demonstrating flexibility and resilience in the face of constraints, frustrations and adversity;
  • Typically serves as a project or team leader for a complex business concept or application;
  • May provide informal or formal feedback to individuals on team;
  • Establishes development and motivation plans for the unit.

Requirements:

  • Higher technical education;
  • Previous relevant experience;
  • ·      Good knowledge of English;

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Leading product-specialist

Main responsibilities:

  • Support to sales-team with technical clarification, product positioning and sales strategy;
  • Prepare all requirement documents for government tenders and their monitoring;
  • Promote different solutions of the Company to the medical market;
  • Introduce good relationships with KOL and references centers;
  • Expand of partnership with key market players in surgery, interventional radiology and cardiology;
  • Calculate the pricing of the solutions in different clinical fields and discuss with management and sales;
  • Perform product-trainings for sales-managers and business-partners;
  • Develop and implement growth programs/ special offers;
  • Support to Quality team with registration process;
  • Internal and external communication with colleagues from headquarter, local departments and business-partners;
  • Direct report to management about current situation on the market, actual pricing and any opportunity to grow.

Requirements:

  • Experience in working in multinational companies;
  • Fluent English;
  • Very strong knowledge of Excel and PowerPoint;
  • Professional knowledge of Russian HealthCare plus work experience 5+ in the position;
  • Strong knowledge of sales process in Russia;
  • Good communication and presentation skills.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Clinical Research Associate (CRA)

Main responsibilities:

  • Assess potential investigators and decide on the suitability of the site;
  • Develop/ adapt recruitment and retention strategy for the site;
  • Efficient and accurate site feasibility visits including analysis of site logistics, site personnel performance/ quality indicators and accountability for patient recruitment strategies;
  • Plan and conduct investigator and site-staff training;
  • Conduct site initiation, monitoring and closure visits;
  • Create site specific and monitoring tools;
  • Guide site staff in preventing protocol deviations (PDs);
  • Collection and management of essential documents;
  • Meet all local and company requirement with respect to safety reporting.

Requirements:

  • University degree in medicine, pharmacy, nursing or biological science;
  • Previous on-site monitoring experience (from 1 year);
  • English-intermediate (oral and written);
  • Strong organizational, communication and teamwork skills, time management, customer service and interpersonal skills;
  • Computer literacy (good knowledge of Word, Excel and Power Point);
  • Flexibility towards work assignment and new learning;
  • Ability to travel (up to 70%).

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Regional Medical Adviser (MSL)

Main responsibilities:

  • KOL Management & Medical Support;
  • Develop professional relationships, build advocacy and gain contributions of KOL/ decision makers;
  • Provide and discuss scientific information and data to healthcare professionals to ensure quality and accuracy of medical and scientific information on new treatment options including company products and selected areas of therapeutic interest;
  • Liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health-economic discussions;
  • Provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by the company;
  • Provide medical support and training (i.e. disease state and product) to company colleagues (e.g. sales reps, CRAs, etc.);
  • Collaborate with Medical Advisors and other cross-functional groups (Sales, Market Access, etc.).

Requirements:

  • Education: MD, PhD will be an advantage, but not necessarily;
  • Intermediate/ Upper-intermediate in English;
  • Good clinical thinking;
  • Excellent interpersonal communication, negotiation and advanced presentation skills;
  • Must be able to adapt, organize, prioritize and work effectively in a constantly changing field-based environment;
  • Ability to travel (up to 50%).

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Medical Adviser

Main responsibilities:

  • Establishment and development of relationships with leading specialists, key opinion leaders for obtaining support in achieving the company’s educational goals;
  • Elaborate the content, design and conduct of all Company innovative Education programs. Lead management of internal and external educational events addressing specific needs of Company stakeholders including physicians, patients, policy makers, regulators and authorities;
  • Monitor the market scientific news, publications, guidelines and regulatory documents, new therapy trends, critically assess new opportunities which can influence the company competitive position;
  • Lead internal medical trainings and develop continuous medical education for the company employees, sales representative;
  • To be responsible for budget planning and execution in granting of manuscripts, medical education, advisory boards and other consultative meetings or activities;
  • Validate data and information in promotional materials created by marketing department being responsible for compliant information and communication; support marketing department with missing information.

Requirements:

  • Medical adviser or Regional Medical Adviser (MSL) experience;
  • Education: MD, PhD will be an advantage, but not necessarily;
  • Upper-intermediate in English;
  • Good clinical thinking;
  • Business planning, leadership skills, negotiation and communication skills, presentation skills;
  • Result-oriented, flexibility, problem-solving, ability to work efficiently under pressure of time and circumstances;
  • Ability to travel (up to 20%).

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Product Manager (Rx/Hospital)

Main responsibilities:

  • Conduct market research, develop and implement marketing strategies and plans;
  • Ensure adherence to marketing budgets;
  • Achieve sales targets (product sales plan, market share growth);
  • Establish and maintain relationships with KOLs;
  • Plan, organize and conduct scientific and marketing events;
  • Prepare marketing materials for product promotion;
  • Conduct product trainings (for staff/ clients);
  • Provide product information for tender specifications;
  • Review and adapt product documentation for registration purposes;
  • Provide planning and reporting in accordance with company standards;
  • Participate in special projects.

Requirements:

  • Higher degree (preferably in Medicine/ Pharmacy);
  • 2+ years of experience as Product Manager in retail/ hospital segment;  
  • Strong knowledge of retail/ hospital market, successful track record of product management & brand development;  
  • Good knowledge of English; 
  • Advanced PC User: Word, PowerPoint, Excel; 
  • Contacts with KOLs in the above mentioned fields would be a plus; 
  • Readiness to travel extensively.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Product Manager (Retail/ OTC)

Main responsibilities:

  • Leads development of brand strategy and marketing plans;
  • Develop documents, tools and promotional materials and relating to the products in compliance with regulatory and legal constraints;
  • Develop proposals for product development;
  • Establish and maintain relationships with KOLs;
  • Active usage of digital channel;
  • Works closely with sales and goes into the field to strengthen their understandings of strategy;
  • Works closely with Supply Chain to ensure good forecasts.

Requirements:

  • Higher education (Preferably pharmaceutical/ medical);
  • At least 2 years of Product/ Brand marketing experience (Pharmacy/ FMCG segments);
  • Good knowledge of English;
  • To be active and ambitious.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Junior Brand Manager

Main responsibilities:

  • Operational marketing including ATL&BTL activities;
  • Provide an OTC marketing strategy; 
  • Using 360 marketing promotion;
  • Participates in and evaluates market research and analyzes;
  • Reviews marketing programs and implements program changes;
  • Plan, organize and conduct scientific and marketing events;
  • Prepare marketing materials for product promotion.

Requirements:

  • University degree;
  • 2 years of marketing experience (Coordinator or Junior Product manager role);
  • Perfect analytical skills, strong experience of working in Excel;
  • Good knowledge of English;
  • Strong user of Microsoft office;
  • Strong leadership and communication skills;
  • Effective multitasker;
  • Result/ achievement oriented.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

 

Medical representative

Main responsibilities:

  • The promotion of drugs and medical devices;
  • Work with doctors and/ or pharmacies;
  • Independent planning of the work within the existing plan of visits;
  • Organization and conducting of the farm circles, presentations;
  • Reporting.

Requirements:

  • Higher medical/ pharmaceutical/ chemical/ veterinary education or higher medical/ pharmaceutical and non-core higher;
  • Experience of medical representative from 1 year is desirable;
  • Result orientation, interpersonal skills, interpersonal communication;
  • Energy, drive, willingness to work in a highly competitive environment.

We offer:

  • Total compliance with all legal requirements;
  • Competitive, official salary;
  • Wide benefits package.

 

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