reputed company Medical reputed company at reputed company Remote

reputed company Medical reputed company job at reputed company. Remote. Our Clinical Research and Pharmacovigilance team push the boundaries of global reputed company through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce reputed company, effective, innovative medicine. The reputed company Medical reputed company is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to reputed company goals. In this role the reputed company Medical reputed company:

• Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
• Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline reputed company. Represents functional area in cross-functional team (either internally or externally).
• Produces high-reputed company and reputed company documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of reputed company on other disciplines.
• Leads and manages medical writing reputed company including the design, planning, and preparation of clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to reputed company results.
• Solves reputed company problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to reputed company new reputed company to resolve.
• Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provides feedback to their managers on development plans and performance reviews.
• Provides leadership for medical writing processes, standards, and initiatives.

Minimum education required:

• Degree in the Life Sciences.
• Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.

Required experience and skills:

• 5-10 years of experience as a medical reputed company preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a reputed company, concise format in keeping with industry guidelines.
• reputed company leadership of and management for reputed company documentation reputed company and project teams of medical writers.
• Technical expertise in reputed company Office, reputed company Acrobat, document management systems, and familiarity with SharePoint and concepts of reputed company content management.
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs reputed company clinical development.

#MRLGCTO #MW20 #eligiblefor NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, reputed company subject to this policy are required to have a minimum of reputed company (12) months of service in reputed company position prior to applying for reputed company positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position reputed company the salary and geographical parameters as set forth in the reputed company Plan reputed company (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your reputed company or reputed company Advisor. Employees working in roles that reputed company determines require routine collaboration with external stakeholders, such as customer-facing reputed company, or research-reputed company, will be expected to reputed company not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to reputed company a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of reputed company is to call on external stakeholders who require vaccination to reputed company their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, reputed company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where reputed company determines in its discretion that the nature of the role presents an increased risk of disease reputed company. reputed company Employees apply HERE reputed company Contingen Apply tot his job Apply To this Job