Manager, Regulatory Medical Writing X-TA

Leiden Bio Science Park; Leiden; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Leiden Bio Science Park is looking for a Manager, Regulatory Medical Writing to support our Integrated Data Analytics & Reporting business. This role involves preparing clinical documents, leading teams, and interacting with senior colleagues.

Applicants should have at least 8 years of pharmaceutical/scientific experience and excellent communication skills. The position offers a hybrid work model with three days onsite every week.

Competenze

• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience required.
• Experience in multiple therapeutic areas preferred.
• Ability to resolve complex problems independently.

Mansioni

• Preparing and finalizing all types of clinical documents.
• Leading a team environment and taking a lead role on assigned projects.
• Proactively providing recommendations for departmental process improvements.

Conoscenze

Attention to detail

Excellent oral and written communication skills

Expert project/time management skills

Strong project/process leadership skills

Formazione

University/college degree

Masters or PhD

Descrizione del lavoro

Overview

We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; or Beerse, Belgium. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

Responsibilities

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
• Guiding or training cross-functional team members on processes and best practices.
• Potentially leading project-level/submission/indication writing teams.
• Proactively providing recommendations for departmental process improvements.
• If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participating in medical writing and cross-functional meetings.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross-functional colleagues to strengthen coordination between departments.
• May be representing Medical Writing department in industry standards working groups.

Qualifications

• University/college degree required. Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
• Experience of multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members. Solid knowledge and application of regulatory guidance documents such as ICH requirements.

Work Arrangement

Hybrid Work – 3 days onsite weekly with remote work options considered on a case-by-case basis and if approved by the company.