Job Description

　　PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. As a Senior Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees. Summarized Purpose: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. Essential Functions: - Serves as primary author who writes and provides input on routine documents such as Job Description R-228376 Sr Med Writer: R-228376 Sr Med Writer (Open) 01:03 pm 05/09/2023 Page 4 of 7 clinical study reports and study protocols and summarizes data from clinical studies. - Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. - Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. - Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes. - May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. - Represents the department at project launch meetings, review meetings, and project team meetings. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Previous experience that provides 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 In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough 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 withstrong presentation skills - Significant knowledge of global, regional, national and other document development guidelines - In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. - Great judgment and decision-making skills - Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Working Environment: PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) PPD Defining Principles: -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 you.