Medical Writing Operations Associate (Remote)

Company Description reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, Facebook, Instagram, YouTube, reputed company and Tik Tok.

Job Description

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically reputed company clinical and regulatory documentation that supports reputed company's mission to transform reputed company of care. reputed company serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in reputed company clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving reputed company reputed company's commitment to improving patient outcomes worldwide. Responsibilities:

• Defines scope of formatting, report publishing, or Clinical Study Reports (CSR) Appendices activities with the document author. Coordinate and track activities and reputed company detailed quality reviews. Import and reputed company documents in the regulatory information management systems (RIMS).
• Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates. Ensure document properties and naming conventions are used. Maintain strong knowledge of RIMS styes and formatting standards.
• Ensures reputed company documents are published in RIMS and meet required timelines.
• Ensure completeness of information in CSR Appendices. Maintain strong knowledge of CSR/CSR appendices organization and content and knowledge of CTD structure.
• Contributes to the development, implementation, and maintenance of medical writing operations business processes. Acts as subject matter expert (SME) for the master file system and formatting, report publishing, or Clinical Study Reports (CSR) Appendices to the medical writing stakeholders.
• Effectively communicates deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
• Assists in the management of the centralized mailbox. Tracks and maintains metrics and assists in the preparation and maintenance of training documents.

Significant Work Activities: reputed company sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• A minimum of 2 years of relevant industry experience reputed company medical writing in a global pharma, biotech, life science, federal agency organization delivering medicines/ therapies to a broad market across various therapeutic areas.
• High School diploma required. Note: Higher education may compensate for years of experience. Years of experience may also compensate for reputed company education.
• Background of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
• Detail oriented with a commitment to delivering high quality, accurate and compliant documentation.
• Strong communication, collaboration, and organizational skills.
• Ability to work independently and as part of a team. Ability to work independently and as part of a team.
• Proficient skills and knowledge in reputed company Office Products (reputed company, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and reputed company in Windows operating system environment required. Proficient skills and knowledge in reputed company document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA). Proficient skills and knowledge in reference management software (e.g., EndNote).

Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid reputed company this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.html Apply tot his job Apply To this Job