Principal Medical Writer

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.
• 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.
• Compensation and Total Rewards at Sobi
• At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.
• The base salary range for this role is 160,000 - 200,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
• All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
• Why Join Us?
• We know our employees are our most valuable assets, and our culture conveys that.

Benefits

Additional Information

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.

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