Principle Medical Writer (remote-based)

Hobson Prior are in search for a Principal Medical Writer to join a world-wide biopharmaceutical organisation on a permanent basis with the ability to work remotely from anywhere in the EU. Our client is focused on providing access to ground-breaking treatments that change the lives of many who live with rare diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• The ideal candidate will be responsible for providing leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents.
• For this role, you will be responsible for leading a method to the composition of the clinical elements of regulatory submissions, warranting a clear, concise, complete, credible and compelling scientific content affiliated 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.
• 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.
• 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.

Key Skills:

• Highly developed analytical and strategic thinking with an ability to identify key issues.
• Highly developed respect for timelines.
• High attention to detail.
• The ideal candidate will have the ability to convey 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.

Requirements:

• For this role, you are required to have a Life Science Master´s degree or PhD and at least 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes.
• Excellent written and spoken English skills.
• You must demonstrate behaviours in line with the company's core values: Care, Ambition, Urgency, Ownership and Partnership.
• 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.
• Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.