Medical & Scientific Affairs Manager – Roche

Website Roche

Medical & Scientific Affairs Manager – Roche

Summary

As a Manager of Medical and Scientific Affairs in Diagnostics division, you are accountable for developing a Medical and Scientific Affairs team. This Role contributes to the collective Medical leadership of the Diagnostics division by ensuring it adheres to the highest scientific, regulatory and ethical standards. It provides strategic direction and leadership to the Medical Department. It develops and starts the implementation of strategies and tactics to increase Medical Value products awareness and their clinical value by focusing on development of educational activities, partnerships with professionals and their associations for respective market and disease segments.

Your Responsibilities

Medical Strategy & Planning

  • Identify unmet medical needs at medical and scientific customer sites, and address questions/concerns from the scientific community
  • Identify key knowledge gaps in medical and scientific field, and propose appropriate action plan
  • Lead local implementation of relevant Scientific Affairs strategies to the region
  • Develop Medical Strategy & Tactics in selected countries; and develop clinical messages for the product line to support the countries
  • Implement tools to monitor medical activities of the department
  • Lead the Scientific Affairs team to achieve the plans
  • Attends appropriate regional and international scientific congresses
  • Manage the Medical Budget

Medical Information

  • Ensure medical and product information is provided in compliance with Global SOPs and local regulatory requirements and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers

Compliance and Training

  • All medical activities must comply with Company policies, guidelines, SOPs, GCP and ethical standards and local legislation
  • Ensure medical review and approval of all promotional materials in compliance with Codes of Practice, Company SOPs, and local regulations
  • Verify the accuracy of training material for scientific information and safety/Quality requirements
  • Medical Affairs staff are fully trained and compliant to Company SOPs and that any issues identified during audits  are resolved

Advisory Boards

  • Responsible for setting up Scientific Advisory Boards to collect input on disease areas, treatment algorithms, clinical data, and/or protocol design, and audience educational needs

Health Economics / Market Access

  • Support the Access Strategy and provide data and advice to support the creation of a dossier of health economic data information for market access applications

Clinical trial activities

  • If appropriate develop medically sound, feasible, studies that enhance product knowledge
    Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations
  • Ensure all local clinical trials and contracts are appropriately approved; executed within agreed timelines and budget; in accordance to Directives, SOPs, quality standards, and regulatory requirements

Internal

  • Work cross-functionally with other internal functions to ensure strategic alignment
  • Responsible for the validation of external medical content
  • Respects and guarantees compliance with all relevant Roche guidelines and policies
  • Establish effective relationships with quality and regulatory, reimbursement to achieve RDME quality and Regulatory objectives.

Leadership / Management

Develop and lead a highly motivated and well-trained team with an objective- and performance-led culture and ensure skilled staff and services in place to support execution of operational plans

Manage the budget/resources allocated to projects in order to meet objectives and targets

Build excellent relationships and interactions between MC Medical, other RDME countries and Global functions

Compliance

You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche.

Who You Are

  • You hold an MD degree or PhD in Life Sciences. Business qualification such as an MBA will be preferred
  • You have at least 10+ years of experience in Life Science Industry or experience in working with senior business leaders, clinicians, and regulatory authorities
  • You are an experienced people manager (at least 2 years); management with and/or without authority. Experienced in developing and coaching of colleagues
  • You are familiar with the medical environment and healthcare system in the Middle East. You are also familiar with the with the disease areas set as a priority for the Company
  • You have sound knowledge of project management tools and processes
  • You are able to drive multiple projects with multiple priorities, as well as have the ability to strategically think through complex opportunities
  • You are able to independently make decisions and recommendations that represent and are aligned with the overall business and product portfolio strategy
  • You have excellent oral and written communication skills, including the ability to articulate clear messages from complex data / information
  • You have excellent presentation, lecturing, and teaching skills
  • You have high ethical standards and alignment with Roche Values
  • You are highly organized with ability to prioritize own tasks as well as those of others, good planning skills and high level negotiating and influencing skills
  • You have strong interpersonal skills and the ability to understand individual needs and motivation
  • You have ability to function comfortably at both strategic and operations level
  • You are fluent in English language, oral and written

Roche is an equal opportunity employer.

To apply for this job please visit bioinformaticsindia.com.