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Essential Document Lead(Remote)

Company: Merck
Location: Saint Paul
Posted on: May 5, 2021

Job Description:

*Job Description* Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards..*Responsibilities* + Support a team of SME in Essential Document Management(EDM) + Support Process Ownership oversight for EDM area + Identifies and proposes strategies, procedures, and tools for the optimization of the processes + Applies creative solutions to complex site ready situations and demonstrates situational leadership within cross-functional teams + Appropriately interacts with external partners for programmatic and functional sourcing + Recognizes and considers various solutions to problems or situations Implementation + Works with internal/external partners to assure document processing times are maintained Strategic Development - Process Management + Identifies best practices and updates processes + Addresses adverse trends in the process following root cause analysis + Updates and maintains all supporting document templates Internal - External Management + Ensures communication with external partners, stakeholders, and customers + Liaises with clinical teams and external partners to achieve site ready timelines + Interfaces with staff members to provide support Audit - Inspection Support + Works with clinical teams, Clinical Quality Management, and Clinical Compliance to ensure inspection process readiness + Assists in the retrieval of documentation during sponsor monitor inspections; participates in mock inspections; participates in inspection training preparation and awareness + Supports the development of responses to audits and inspections and ensures appropriate implementation + Ensures that all actions and commitments are implemented in a timely manner.*Education Requirements* + Bachelor degree - Degree concentration should be in a related health field or strong emphasis on science + Master's Degree preferred..*Required Experience & Skillset:* + Minimum of 5 years of relevant experience. + Significant knowledge of ICH/GCP, Knowledge of health care regulations in EMA and MHRA..* This is a remote opportunity* We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe..*Who we are ...* We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world..*What we look for ...* In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue.*Inventing For Life, Impacting Lives* while.*Inspiring Your Career Growth* . Invent. Impact. Inspire..*NOTICE FOR INTERNAL APPLICANTS* In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor..*Residents of Colorado* Click here () to request this role's pay range. Current Employees apply HERE ($1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE ($4020.htmld).*US and Puerto Rico Residents Only:* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ( [survey.sogosurvey.com]) if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster () EEOC GINA Supplement? OFCCP EEO Supplement (\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace..*Search Firm Representatives Please Read Carefully* Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails..*Employee Status:* Regular.*Relocation:* No relocation.*VISA Sponsorship:* No.*Travel Requirements:* 25%.*Flexible Work Arrangements:* Remote Work.*Shift:* 1st - Day.*Valid Driving License:*.*Hazardous Material(s):*.*Number of Openings:* 1.*Requisition ID:* R113705

Keywords: Merck, St. Paul , Essential Document Lead(Remote), Other , Saint Paul, Minnesota

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