Medical Writing Manager (Pharmacovigilance)

Medical Writing Manager ( Pharmacovigilance )  Position Summary The Medical Writing Manager (Pharmacovigilance) is responsible for writing and editing a variety of scientific and medical content, including but not limited to the following: Aggregate Reports, Risk Management Plan(RMP), Risk Evaluation and Mitigation Strategies (REMS), protocols, investigator brochures, clinical study reports, responses to regulatory questions and other clinical and regulatory documents, in accordance with applicable Good Clinical Practice requirements and legislation. The medical writer will work independently to review Client documents and author the reports. The medical writer will collaborate with the PV Project Leads and other relevant functions to ensure accuracy and clarity of all relevant content. Essential To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s) Proactively contribute to development and implementation of Medical Writing best practices, policies, SOPs and process improvement initiatives leading to efficient and improved standards and systems for authoring, review, editing and finalization of documents, in compliance with applicable company SOPs and regulations; Develop and refine templates to improve inter-department/program alignment and efficiency in accordance with standards and regulatory guidelines and requirements; Define document development strategy and resource needs for programs, including medical writing vendor engagement and oversight; Drive document execution tactics, such as: define document development, implement review and revision processes, develop timelines including timelines related to document birth dates, assign resources, facilitate document-related meetings, provide cross-functional updates and define data needs, etc. to ensure timely completion of key documents for complex global programs; Author, edit, and quality review a variety of scientific and medical documents, including but not limited to the following: Aggregate Reports, Risk Management Plan(RMP), Risk Evaluation and Mitigation Strategies (REMS), protocols, investigator brochures, clinical study reports, responses to regulatory questions and other clinical and regulatory documents, in accordance with applicable SOPs, Good Clinical Practice requirements and legislation. Collaborate with clients and the PV staff to ensure that all documents meet the required standards for content, format and style; Maintain up-to-date knowledge of relevant therapeutic areas and scientific developments; Develop and practice ongoing scientific expertise relevant to therapeutic areas, product labelling, pivotal studies, and disease state management; Integrate scientific expertise with regulatory and compliance guidelines to ensure comprehensive review and creation of materials submitted into approval process; Use appropriate software/platforms/available tools to organize and maintain references for documents; Attend and participate in all appropriate client and internal meetings Support the continuous development of the Medical Writing capabilities; provide ongoing training/mentoring to the PV team members, as needed; Inform the Global Head of PV and DS when required, of the status of projects and, in particular, any issues that affect document quality and project budget; Provide new business cost estimates when required, and support the GHPD and Business Development team in new business acquisitions for PV projects including medical writing services. Position Qualifications Competency Statements Excellent working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes. Superior writing and editorial skills, strong data analysis skills, ability to interpret clinical data and understand complex scientific and clinical information and create consistent strategic messaging for diverse audiences. Ability to contribute to, oversee and coordinate work of multiple PV staff members and vendor resources across multidisciplinary teams Teamwork, communication, collaboration and alignment across a matrix organization are essential Commitment to delivering high-quality timely results, leading by example, demonstrating agility, and navigating ambiguity are critical to success Demonstrates innovative capacity and ability to implement change Ethical - Ability to conform to a set of values and accepted standards. Accountability - Ability to accept responsibility and account for his/her actions. Accuracy - Ability to perform work accurately and thoroughly. Analytical Skills - Ability to use thinking and reasoning to solve a problem. Detail Oriented - Ability to pay attention to the minute details of a project or task. Self Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative. Organized - Possesses the trait of being well organized or following a systematic method of performing a task. Technical Aptitude - Ability to comprehend complex technical topics and specialized information. Financial Aptitude - Ability to understand and explain economic and accounting information, prepare and manage budgets, and make sound long-term investment decisions. Tactful - Ability to show consideration for and maintain good relations with others. Problem Solving - Ability to find a solution for or to deal proactively with work-related problems. Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others. Customer Oriented - Ability to take care of the client needs while following company procedures. Communication, Written - Ability to communicate in writing clearly and concisely. Communication, Oral - Ability to communicate effectively with others using the spoken word. Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience. Demonstrated leadership skills. Excellent influencing and negotiation skills. Demonstrated ability to work in a matrix environment. Ability to establish and maintain effective working relationships with co-workers, managers and clients. Fluent in English. Experience 8-10 years of relevant experience including education and/or medical writing experience within pharmaceutical/biotech industry. Direct experience in the pharmaceutical/biotech industry with understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications Other Requirements: pharmaceutical industry experience including an understanding and working knowledge of global legal, regulatory, and compliance requirements with regards to pharmacovigilance. Computer Skills Proficiency with Embase, OvidPV, PubMed, Microsoft Office Suite (Outlook, Word, Excel), safety databases, such as Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy, etc. WORK ENVIRONMENT Remote The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.   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