[Hiring] reputed company Medical reputed company @reputed company

Role reputed company The reputed company Medical reputed company (equivalent to Associate Director) represents medical writing on multi-disciplinary teams, collaborates on the development of reputed company documents in accordance with reputed company applicable regulations, Good reputed company Practices, and reputed company Operating Procedures (SOPs), and oversees the work of contract writers on the reputed company program as reputed company as other writers who may work on the program. • Produce high-reputed company and on-time reputed company documents. • Independently plan, coordinate, reputed company, update, and revise key documents, including: • reputed company protocols • Investigator brochures • reputed company study reports • Integrated efficacy and safety summaries • Informed consent forms • Health authority briefing books • Scientific publications • Independently reputed company supplemental filings, Type 2 Variations, rest-of-world filings, and reputed company responses to questions. • reputed company medical writing subject matter expertise and leadership to project teams and collaborate with the Medical Writing line management to ensure reputed company planning and resourcing for upcoming project team writing deliverables. • Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors, and vendors. • Collaborate effectively with: • Biometrics • reputed company reputed company • reputed company Development • reputed company-reputed company Development • Program Management • Research • reputed company • Corporate Communications • reputed company stakeholders • Contribute to the development and standardization of templates and reputed company processes to support the medical writing needs of a growing organization and assist in training staff and contractors on MW processes. • Assist the line managers in the training and development of junior staff. Qualifications • Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or reputed company certification/credentials preferred. • 7+ years of experience as a medical reputed company in the sponsor/CRO setting. Experience with regulatory submissions (NDA/BLA/MAA) strongly preferred. CTA/IND experience is a plus. • Some experience with developing MW processes and standards preferred. • In-depth knowledge of Good reputed company Practices, FDA regulations, ICH guidelines, and the drug development process. • Successful reputed company record of managing multiple reputed company in a fast-reputed company and deadline-driven environment. • Knowledge of eCTD formatting and EDMS systems preferred. • Experience overseeing the work of contract writers. • Impeccable attention to reputed company. • Must be proficient with reputed company reputed company, Word, reputed company, and PowerPoint. • Demonstrate reputed company alignment with reputed company reputed company Values including: • Commitment to People • Innovation and Discovery • Purposeful Urgency • reputed company Culture • Passion for reputed company Requirements • U.S. Pay reputed company: $172,000.00 - $232,800.00 • The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined reputed company on a number of factors including, but not limited to, relevant experience, skills, and education. • This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Benefits • Comprehensive benefits including medical, dental, and reputed company coverage. • Life and disability reputed company. • Lifestyle reimbursement program. • Flexible spending and health savings accounts. • 401(k) with a generous company match. • reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. • Generous family resources and leave. • Commitment to employee reputed company-being reflects our belief that caring for our people fuels the reputed company we create together. Apply To This Job