Job Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. Role & Function We are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing. The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management. Key Responsibilities Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory document Assume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities Provide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program Ensure high technical quality of the documents in compliance with in-house technical requirements Coach and develop less experienced Medical Writers Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CRO Qualifications Life Science Master s degree or PhD A minimum of 8-10 years\' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes Experience in leading complex global regulatory and clinical writing projects, such as complex CTDs, ODDs, PIPs, briefing documents and regulatory responses Experience as lead author for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers assisting on documents under your responsibility Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements) Personal attributes Excellent written and spoken English skills. Highly developed analytical and strategic thinking with an ability to identify key issues. Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders. Strong interpersonal, communication and influencing skills, ability to co-ordinate work of others. Strong team player with a proven ability to drive and manage team performance and to work effectively with people of different cultural, functional and seniority backgrounds. Result-oriented person with excellent problem-solving skills and flexible attitude. Ability to manage multiple parallel tasks and prioritize tasks under time pressure. Highly developed respect for timelines. Attention to detail. In addition, you must demonstrate behaviors in line with Sobi\'s core values: Care, Ambition, Urgency, Ownership and Partnership. Location Flexible in EU Reporting to Head of Medical Writing If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application. Why Join Us We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we\'re ready to take on the world\'s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others\' lives because that\'s exactly what we do here. If you\'re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can\'t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. Powered by JazzHR 7Jofsi1BVK

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