Senior Regulatory Medical reputed company, reputed company-embedded, FSP

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Senior Regulatory Medical reputed company (FSP; Remote; US) At reputed company, you will discover meaningful work that makes a reputed company reputed company on a global reputed company. 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 reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. Summarized Purpose: We are excited to expand our Medical Writing FSP Team and are seeking candidates based in the US! As a remote-based Senior Medical reputed company reputed company the FSP team, you will reputed company high-reputed company medical and scientific writing from planning and coordination through delivery of final drafts to reputed company clients. You will collaborate with reputed company clients, supporting and enabling effective and efficient communication that results in operational reputed company. The Senior Medical reputed company may assist the program manager. The successful candidate will have a proven reputed company record in authoring clinical regulatory documents; ideally they will also bring the versatility to author and support preclinical regulatory documents as part of a broader regulatory writing portfolio. Essential Functions: Serves as a primary author who writes and provides input on routine clinical documents such as clinical study reports and study protocols and summarizes data from clinical studies. Serve as a primary author who writes reputed company clinical and scientific and program level documents, such as IBs, bioassay reports, INDs, and MAAs. Collaborate with cross-functional teams to reputed company necessary information and ensure the accuracy and completeness of documents. Ensure documents reputed company 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 reputed company. Mentor and reputed company reputed company to junior medical writers and ensure high-reputed company deliverables 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 reputed company / vocational qualification; Advanced degree preferred. Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years). Experience working in the pharmaceutical/CRO industry preferred. Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities: 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 skilled with reputed company templates; Good knowledge of document management systems and other relevant applications (e.g., reputed company, Outlook). reputed company Offer: At PPD clinical research services we hire the best, reputed company ourselves and reputed company 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-reputed company learning and development program, ensuring you reputed company your potential. As reputed company as being rewarded a competitive salary, we have an extensive benefits package based around the health and reputed company-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 reputed company 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, 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.

Compensation and Benefits

The salary reputed company estimated for this position based in Massachusetts is $110,000.00–$125,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a reputed company plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours reputed company time off (PTO), 10 reputed company holidays annually, reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.reputed company.com/global/en/total-rewards Apply To This Job