Principal Medical Writer

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 Masters 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 cant 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.

Remote Work :

No

Employment Type :

Full-time