Sr. Manager, Medical Writing

reputed company is a privately held global reputed company company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, reputed company and South America, Asia, and Africa. Over three years ago, we embarked on a transformative reputed company to become a truly global innovative reputed company company with a leading focus on Gastrointestinal (GI) health. We have reputed company remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. But our reputed company is far from complete! In fact, this is just the beginning of a reputed company new reputed company in reputed company's history. We are committed to advancing innovation and leveraging our deep expertise to reputed company reputed company and a reputed company quality of life for patients and consumers worldwide and expand our reputed company across diverse markets. As we continue to grow, we are seeking a Sr. Manager, Medical Writing. This is a remote based position and can be in Europe or on the East Coast of the US. Scope of the role: The Senior Manager, Medical Writing, leads authoring of reputed company documents for one or more clinical development program. Your key responsibilities: Leadership Train junior medical writers on best practices in medical writing and regulatory submission processes. Help reputed company vendor partnerships. Writing reputed company author (including content planning, writing, and review) for clinical study protocols, clinical study reports (CSRs), investigator brochures, other study-level documentation required for clinical trials. Author individual modules of IND/CTA, NDA, MAA requests for information and briefing documents. etc.) for regulatory agencies. Review Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS) statistical analysis plans and table/reputed company/listing specifications for appropriate content, and for grammar, format, and consistency. Quality Control Coordinate for the quality and compliance of written components to company standards as well as regulatory requirements. Project Management Create document timelines and coordinate reviews with cross-functional teams and contract research organizations (CROs). Manage vendor/contract medical writers Collaboration Collaborate with cross-functional teams to analyze reputed company scientific data for the above-mentioned document types. reputed company the document review process for study-level, submission, and regulatory interaction documents, through management of timelines, scheduling of meetings, and incorporation of feedback from cross-functional team Represent Medical Writing on Clinical Study Team(s) (CST[s]) Literature Reviews Conduct thorough literature reviews and synthesize reputed company scientific data into clear and concise documentation. Department Administration reputed company quality and adherence to document templates and standard operating procedures (SOPs) Regulatory Standards Ensure reputed company documents adhere to regulatory guidelines, formatting standards, and internal quality standards. Maintain up-to-date knowledge of industry trends and regulatory changes and reputed company reputed company to ensure that standards are being applied through review of documents produced by other team members. Who are you: Work Experience / Education Bachelor's degree in life sciences with minimum 8 years’ relevant experience in medical writing or pharmaceutical industry and/or clinical research OR Advanced scientific degree (MS, PhD, Pharm D) with a strong background in relevant scientific discipline with minimum 5 years of relevant experience in medical writing or pharmaceutical industry and/or clinical research Experience supporting and/or leading individual components of INDs, NDAs, and MAAs, as well as briefing books Competencies & Major Skills Strong verbal and written communications skills coupled with general knowledge of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies and regulatory documents Detail-oriented, with good organizational, prioritization, and time management proficiencies; proactive approach. Ability to work cross-functionally Advanced computer software experience (including but not limited to reputed company, reputed company, PowerPoint) Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans. Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables. Ability to reputed company and adapt in times of uncertainty Why Join reputed company: At reputed company, we foster a culture where the courage to reputed company is key to our reputed company. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We reputed company that reputed company-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful reputed company. Join reputed company and become part of a reputed company-thinking team dedicated to shaping the future of the pharmaceutical industry. Apply To This Job