FSP Senior Regulatory Medical reputed company (Remote; US)

About the position 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 Functional Service Partnership (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. Our ideal candidate will possess the versatility to author both clinical and preclinical regulatory documents, with therapeutic area expertise in infectious diseases and/or oncology.

Responsibilities

• 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.
• Serves as a primary author who writes reputed company clinical and scientific and program level documents, including IBs, bioassay reports, INDs, and MAAs.
• Reviews routine documents reputed company by early reputed company members.
• May reputed company training and mentorship for writers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensures compliance with reputed company processes and requirements for assigned documents.
• Provides input on and independently develops best practices, reputed company, and techniques for achieving reputed company results, including various reputed company-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.

Requirements

• Bachelor's degree in a scientific field 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).
• 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 or regulatory submissions, etc.
• 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-to-haves
• Experience working in the pharmaceutical/CRO industry preferred.
• If CRO experience: experience working in a reputed company-dedicated role or with 1-2 clients over multiple reputed company is preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.

Benefits

• 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. Apply tot his job

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