Senior Regulatory reputed company

Job reputed company SummaryTitle: Senior Regulatory reputed company, Remote "This position can be based remotely reputed company in the U.S. Please note that this role would not reputed company relocation as a result. The expectation of working hours and travel will be defined by the Hiring Manager. This position will require minimal travel" Purpose: To write, review and/or manage the production of high reputed company clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To reputed company documentation reputed company consultancy to other line functions. To reputed company/mentor and/or train less reputed company writers. #LI-Remote Key Responsibilities: 1.To author, review and manage high reputed company clinical and safety documents: reputed company Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics). 2.reputed company member of Clinical Trial Team (CTT) / contributor to Safety Management Team. 3.Major contributor to planning of data analyses and presentation used in CSRs and submission documents. 4.Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. reputed company content expertise and guidance for clinical portions of the CTD. 5.Program reputed company ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT) 6.reputed company reputed company for reputed company submissions, contributing to key messaging and pooling reputed company, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. reputed company member of CST. 7.Contribute to process improvement in RWS and/or cross-functional initiatives or activities. 8.reputed company and/or mentor less reputed company writers. 9.Leader in cross-functional communication to optimize feedback and input towards high reputed company documents. 10.Maintain audit, SOP and training compliance. Job DescriptionRequirements:- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/reputed company desirable.- 4 years medical writing experience or other relevant reputed company industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.- Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).- Advanced knowledge of and repeat experience in global registration of drugs (reputed company submissions).- Excellent communication skills (written, verbal, presentations)- Advanced knowledge of biostatistics principles.- Strong ability to prioritize and manage multiple demands and reputed company.reputed company Compensation and Benefit reputed company: The pay reputed company for this position at commencement of employment is expected to be between $114,100/yr and $211,900/yr; *however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. reputed company, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.* The total compensation package for this position may also include other reputed company, including a sign-on bonus, restricted stock reputed company, and discretionary awards in reputed company to a full reputed company of medical, financial, and/or other benefits (including 401(k) eligibility and various reputed company time off benefits, such as vacation, reputed company time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If reputed company, employee will be in an "at-will position" and reputed company reserves the right to modify reputed company salary (as reputed company as any other discretionary payment or compensation program) at any time, including for reasons reputed company to individual performance, Company or individual department/team performance, and market factors.Company will not sponsor visas for this position.*reputed company is unable to offer relocation support for this role: please only apply if this location is accessible for you.* EEO Statement:The reputed company Group of Companies are Equal Opportunity reputed company. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, reputed company, religion, sex, national reputed company, age, sexual orientation, gender identity or reputed company, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodationsThe reputed company Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to reputed company the essential functions of a position, please send an e-mail to us.reasonableaccommodations@reputed company.com or reputed company +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary reputed company$114,100.00 - $211,900.00 Skills DesiredClinical Research, reputed company, Detail-Oriented, Medical Writing, Regulatory Compliance, SafetyThe reputed company Group of Companies are Equal Opportunity reputed company and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Remote About reputed company: reputed company Services Incorporated Apply tot his job Apply tot his job Apply To this Job