Principal Medical Writer

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the

qualifications

. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the

qualifications

. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

As a Principal Medical Writer, you will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission packages and clinical programs, to facilitate regulatory assessment, and to achieve a product label that fulfills commercial needs.

Key responsibilities:

• Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise, complete, credible and compelling scientific content aligned with the objective of the regulatory document.
• Assume primary responsibility for preparation of key clinical and 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

Qualification and experience:

• 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 CSRs, CTDs, ODDs, PIPs, briefing documents and regulatory responses
• Experience in leading writing activities for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers and submission leadership
• 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)

Skills and 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.

Additional Information

Why Join Us?

We are a global company with over 1,900 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 assets, 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.