Senior Regulatory Medical Writer, Client-embedded, FSP

Description

The company runs clinical trials in more than 100 countries and offers laboratory, digital and decentralized trial services.

The company has over 100,000 colleagues and is growing its Medical Writing FSP team with people based in the US.

This is a remote role for a Senior Medical Writer who will deliver high-quality medical and scientific writing from planning to final drafts for internal and external clients.

The ideal candidate has a proven record of writing clinical regulatory documents. Experience with preclinical regulatory documents, as part of a wider regulatory writing portfolio, is ideal but not essential.

Responsibilities

• Act as primary author for routine clinical documents, such as clinical study reports and protocols, and summarise data from clinical studies.
• Act as primary author for complex clinical, scientific and program-level documents, such as IBs, bioassay reports, INDs and MAAs.
• Gather information from cross-functional teams and check that documents are accurate and complete.
• Make sure documents meet regulatory guidelines, company standards and industry best practice.
• Advise on document content, structure and presentation.
• Review drafts written by other team members and give feedback.
• Plan timelines and deliverables for your assigned projects.
• Mentor junior medical writers and oversee their work to keep quality high.
• Keep up to date with industry trends, guidelines and regulatory requirements.
• You may assist the program manager.

Requirements

• Bachelor's degree in a scientific discipline, or an equivalent academic or vocational qualification.
• Experience comparable to 5+ years, giving you the knowledge and skills for the role.
• Proven track record authoring clinical regulatory documents.
• Excellent data interpretation and medical writing skills, including grammar, editing and proofreading.
• Strong project management, problem-solving and interpersonal skills.
• Strong negotiation skills.
• Excellent oral and written communication, with strong presentation skills.
• Significant knowledge of global, regional, national and other document development guidelines.
• Good judgment and decision-making.
• Excellent computer skills, including working with client templates, document management systems and tools such as Excel and Outlook.
• Advanced degree preferred.
• Experience in the pharmaceutical or CRO industry preferred.
• Preclinical regulatory writing experience ideally, as part of a broader regulatory writing portfolio.
• Additional qualifications from AMWA, EMWA or RAC are advantageous.
• An equivalent combination of education, training and directly related experience may be considered in place of the stated requirements.

Conditions

First shift (days) schedule.

Remote role for candidates based in the US.

The posting also lists the environment as office.

Benefits

• Award-winning learning and development program to support your professional and personal growth.
• Competitive salary.
• Extensive benefits package focused on health and wellbeing.
• Flexible working culture that values work-life balance.
• Collaborative, global organization with a local feel.