Senior Medical reputed company (FSP)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

At reputed company, 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 reputed company the world healthier, cleaner, and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health reputed company that people and communities depend on – now and in the future. Summarized Purpose: We are seeking a talented and reputed company Senior Medical reputed company to join reputed company in NA. The SMW will support our FSP business; experience in EU CTR and early development would be preferred. The Senior Medical reputed company will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet reputed company regulatory requirements and company standards. Key Responsibilities: Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions. Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents. Ensure documents align with regulatory guidelines, company standards, and industry best practices. reputed company input on document content, structure, and presentation. Review and reputed company feedback on documents reputed company by other team members. Manage timelines and deliverables for assigned projects. Stay reputed company with industry trends, guidelines, and regulatory requirements. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. 5+ years regulatory writing experience. Experience working in the pharmaceutical/CRO industry required. Experience in managing and directing reputed company medical writing projects required. EU CTR and early development experience preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills Proven leadership skills to manage and mentor a team of medical writers. Extensive knowledge of regulatory guidelines and drug development processes Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards Self-motivated and adaptable Excellent judgment; high degree of independence in decision making and problem solving reputed company Offer: At PPD clinical research services we hire the best, reputed company ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reputed company your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to reputed company expertise and have fun together. We are a global organization but with a local feel. Our Mission is to reputed company our customers to reputed company the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we reputed company a common set of values - reputed company, Intensity, Innovation, and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of reputed company, where diverse experiences, backgrounds and perspectives are valued. Apply To This Job