• Principal Medical Writer, Regulatory


    Job #1228516847

  • /Principal Medical Writer, Regulatory // /We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: toimprove health. You will be joining a truly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients. PPD has an exciting opportunity for a Principal Medical Writer to join our Global Medical Writing Team.The Phase II-IV Medical Writing group, which is part of the Biostatistics Department, is a rapidly expanding team of over 100 regulatory writers based in Europe, North America and Asia Pacific. Our writers prepare documents in support of clinical trials and assist Regulatory Affairs professionals with marketing applications, INDs, pediatric investigational plans, clinical trial applications, and other types of regulatory documents.Our writers possess strong leadership and project management skills, are creative problem solvers and decision makers, are engaging mentors and enthusiastic members of the department with an eagerness to continually improve our offerings and deliver a market leading service to our clients. In return, the medical writing department offers a highly competitive compensation package together with excellent opportunities for personal development and progression within the field. All within a friendly, fast paced and exciting ~~~ a Principal Medical Writer, you will be responsible for: Acting as a primary author who writes and provides input on complex clinical and program level documents, including IBs, INDs, and MAAs. Providing senior level review of routine and complex documents; training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.* Ensuring compliance with quality processes and requirements for assigned documents.Ideally, you will have:* Education to Bachelor's/advanced degree level in a scientific discipline* 5 years of experience within regulatory medical writing* Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilitiesKnowledge, Skills, and Experience:* Significant knowledge of global, regional, national and other document development guidelines* In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.* Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills* Excellent project management skills* Advanced interpersonal, oral and written communication, and presentation skills* Excellent negotiation skills* Excellent judgment; high degree of independence in decision making and problem solving* Ability to mentor and lead junior level staffAt PPD we hire the best, develop ourselves and each other, and recognise 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 you will benefit from an award-winning learning and development programme, ensuring you reach your ~~~ 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 truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD -If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from ~~~ we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.#LI-SS1Job: Medical WritingOrganization: PPDTitle: Principal Medical Writer, RegulatoryLocation: Europe, Middle East %26 AfricaRequisition ID: 169389Other Locations:** GB-GB-Bellshill, GB-GB-Cambridge, ZA-South Africa, ES-ES-Madrid, GB-GB-WinchesterPPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group

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