Senior Medical Writer (FSP) Remote North Carolina, United States of America Full time Remote Summarized Purpose:  We are seeking a talented and experienced Senior Medical Writer to join our team in NA. The SMW will support our FSP business; experience in EU CTR and early development would be preferred. The Senior Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards. Key Responsibilities: - Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions. - Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents. - Ensure documents align with regulatory guidelines, company standards, and industry best practices. - Provide input on document content, structure, and presentation. - Review and provide feedback on documents prepared by other team members. - Manage timelines and deliverables for assigned projects. - Stay current with industry trends, guidelines, and regulatory requirements. Education and Experience:  - Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.  - 5+ years regulatory writing experience.  - Experience working in the pharmaceutical/CRO industry required.  - Experience in managing and directing complex medical writing projects required. - EU CTR and early development experience preferred.   Knowledge, Skills, and Abilities:  - Excellent organizational and program management skills  - Proven leadership skills to manage and mentor a team of medical writers. - Extensive knowledge of regulatory guidelines and drug development processes - Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders  - Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards - Self-motivated and adaptable  - Excellent judgment; high degree of independence in decision making and problem solving    What We Offer:  As 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 clinical research services truly value a work-life balance. We have 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 organization but with a local feel.

Title: FSP Principal Medical Writer - Germany (m/f/d) Location: Remote Germany Full time Remote We are excited to expand our Medical Writing FSP Team in Germany! This would be a remote role working from any location in Germany. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Neurology, Immunology, Oncology or Vaccines would be valuable but not essential. As a Principal Medical Writer you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, you will review documents for the team and provide training and guidance to junior team members. As a subject matter expert you will provide advice on document development strategy, regulations, and industry best practices. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. Essential Functions: - Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies. - May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. Provides senior level review of routine and complex documents. Provides 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. - Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods, and techniques for achieving optimal results, including various client- specific processes, and leads process improvement initiatives. May also develop, review, and manage performance metrics for assigned projects. - 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 8+ years). Experience in managing and directing complex medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Submissions document experience advantageous Experience in Neurosciences advantageous Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Knowledge, Skills, and Abilities: - 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 staff.   What We Offer: As 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 clinical research services truly value a work-life balance. We have 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 organization but with a local feel.

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Title: Senior Editor | EDU | RVPR Location: San Juan, PR Work Type: Hybrid Job Description: This role requires a hybrid schedule and will be based in our San Juan, PR office (Monday through Thursday) and work fully remotely on Fridays each week. Curious how RV Education (EDU) fits into Red Ventures? Click here. At RV Education (EDU), we believe in the power of online learning to create opportunities and transform lives. In partnership with over 300 colleges and universities, we help individuals make smart educational decisions that meet their needs and career aspirations. Our trusted brands like BestColleges serve over 90 million unique annual visitors with educational resources and advice. Red Ventures is seeking an experienced Senior Editor to help accelerate our coverage of college degrees, certificates, bootcamps, training programs, and other educational and career pathways. This position requires precision storytelling and editing, the ability to coach and develop junior writers and editors, and experience managing an editorial calendar. You will be responsible for assigning content, upholding editorial standards and SEO guidelines, high-level editing for clarity and organization, and participating in content strategy and ideation. In addition to managing a team, you should be nimble, creative, and curious, capable of anticipating trending issues and stories. A collaborative mindset and ability to work as part of a team is a must. RV EDU is proudly headquartered in San Juan, Puerto Rico, and is dedicated to cultivating local talent and driving economic development on the island. While many of our roles are located in Puerto Rico, some are also located at RV's main campus south of Charlotte, NC, or are remote-based. We believe that diverse, inclusive teams are better teams. Think of the bullets below as guidelines: If you only partially meet the qualifications on this posting, we encourage you to apply anyway! What You'll Do - Outline and edit consumer-facing content related to online education, degrees, courses, bootcamps, and other educational and career pathways - Assign content and provide editorial feedback to writers - Manage and monitor freelance and internal writer performance and production - Monitor industry trends and innovations in online education - Uphold editorial guidelines and best practices - Approve pieces for publishing and provide high-level edits for clarity, facts, and organization when needed - Help manage the production workflow of an editorial calendar with multiple inputs - Help define content goals by working collaboratively with other teams, including publishing and SEO - Learn and employ SEO best practices to ensure content is highly visible in search engines - Balance a high-volume workload to ensure we hit our monthly publication goals What We're Looking For - 5+ years of experience in a digital media, journalism, or digital marketing environment - Ability to assign and edit content on a quick turnaround - Experience managing writers and editors - Familiarity with higher education is a plus, but not required - A bachelor's degree in journalism, English, creative writing, or a related field - A portfolio of published work or writing samples - In-depth research skills and high attention to detail - Strong familiarity with AP Style and journalism fundamentals - Self-motivated with a track record of success managing multiple projects and meeting deadlines - Familiarity with SEO best practices - Familiarity publishing on WordPress or a similar CMS Compensation: We offer a competitive offer package including base salary and benefits. Actual compensation varies based on location, experience, and qualifications. Additionally, the following benefits are provided by Red Ventures, subject to eligibility requirements. - Health Insurance Coverage (medical, dental, and vision) - Holiday Pay - 401(k) with match - Flexible Paid Time Off (PTO): We believe time to rest and recharge is essential. That's why we offer a generous and flexible PTO policy. Full-time employees accrue 20 days of PTO for a full calendar year annually, with an increase to 25 days after five years of service. Who We Are: Red Ventures is an equal opportunity employer that does not discriminate against any employee or applicant because of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or any other basis protected by law. Employment at Red Ventures is based solely on a person's merit and qualifications.