We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Sr / Prin Medical Writer, Regulatory
(East Coast Home-based) As part of our on-going growth, we are currently recruiting for a Senior / Medical Writer to join our rapidly expanding team of over 160 regulatory writers based in Europe, North America and Asia Pacific.

The Phase II-IV Medical Writing group, includes Writers who prepare documents in support of clinical trials and who 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 environment. As a Sr/Prin 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. The PPD FSP Solution: PPD\'s Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customer\'s key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success. You will be a part of a team who is dedicated to its people and foster a supportive, collaborative culture based on trust, flexibility and work life balance. This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD Clinical Research Services colleagues to deliver leading edge clinical support. 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 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 regulatory medical writing experience (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

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
• 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.)