[Hiring] Senior Regulatory Medical Writer @Thermo Fisher Scientific

Role Description

Senior Regulatory Medical Writer (FSP; Remote; US)

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

• Expand our Medical Writing FSP Team and seek candidates based in the US.
• Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
• Collaborate with internal and external clients to support effective communication and operational excellence.
• Assist the program manager as needed.
• Proven track record in authoring clinical regulatory documents; versatility to author and support preclinical regulatory documents is ideal.

Essential Functions:

• Serve as a primary author for routine clinical documents such as clinical study reports and study protocols.
• Write complex clinical and scientific program level documents, such as IBs, bioassay reports, INDs, and MAAs.
• Collaborate with cross-functional teams to gather necessary information and ensure document accuracy and completeness.
• Ensure documents align with regulatory guidelines, company standards, and industry best practices.
• Provide input on document content, structure, and presentation.
• Review and provide feedback on documents prepared by other team members.
• Manage timelines and deliverables for assigned projects.
• Mentor and provide oversight to junior medical writers to ensure high-quality deliverables.
• Stay current with industry trends, guidelines, and regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; Advanced degree preferred.
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• Equivalency of appropriate education, training, and/or directly related experience may be considered sufficient.

Requirements

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills.
• Strong project management skills.
• Excellent interpersonal skills including problem solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national, and other document development guidelines.
• Great judgment and decision-making skills.
• Excellent computer skills and proficiency with client templates; good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).

Benefits

• Competitive salary.
• Extensive benefits package focused on employee health and well-being.
• Flexible working culture valuing work-life balance.
• Award-winning learning and development program for professional and personal growth.
• Collaborative environment with teams eager to share expertise and have fun together.