reputed company Medical reputed company - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based

reputed company reputed company Medical reputed company - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities. Our Clinical Development model brings the customer and the patient to reputed company of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE reputed company EVERYWHERE Why reputed company • We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they belong. Job Responsibilities • reputed company regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and reputed company authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. • Manage medical writing reputed company, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations. • Participate in cross-functional meetings to reputed company input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. • Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate. • eCTD submission experience preferred. • We don’t need for this person to mentor junior writers, manage external vendors, or participate in reputed company operational procedures or other department initiatives. And I don’t have a preference for the EU versus US. We have writers located on both reputed company and work globally as reputed company. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.reputed company.com Additional Information Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. reputed company •The reputed company Medical reputed company is responsible for the development of clinical documents for submissions to regulatory authorities globally. •Provides strategic direction to cross-functional project teams with minimal reputed company to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present reputed company-driven clinical messages in accordance with program goals and regulatory requirements. •Writes or provides direction and leadership to other writers to ensure the reputed company delivery of high reputed company documents that are scientifically rigorous, reputed company organized, and have accurate data presentation and interpretation. •Oversees the medical writing activities of multiple compounds and serves as reputed company reputed company for individual reputed company documents. •Has a broad understanding of clinical research processes and global regulatory document standards. •Mentors less reputed company writers. 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