Merck Senior Principal Medical Writer in Carson City, Nevada
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
The Senior Principal Medical Writer is an individual contributor role for an industry expert in the domain who is responsible for providing specialist technical, regulatory, strategic and scientific leadership for a broad portfolio of Medical Writing projects that span all therapeutic areas, the department’s full scope of work and frequently involve cross-functional work for the support of key clinical development pipeline assets. The role may include supervision of a limited number of direct reports. This scope of work addresses the highest level of forward planning and problem solving for documentation and its structured components, timelines, resources, and process efficiencies to maximize the value added to corporate business goals through clinical documentation.
The Senior Principal Medical Writer primary responsibilities:
Uses leading-edge knowledge of principles, concepts, practices and/or techniques to champion complex projects or programs involving Medical Writing and related departments/groups.
Recognized internally and externally as a leading contributor to solution generation and delivery for special projects for the Medical Writing Department such as development of best practices for new and evolving documentation, technological advances to increase efficiency, and guidance for integration of acquisitions and working in collaborations.
Demonstrates thought leadership in Medical Writing and represents our company's Medical Writing as an expert for external collaborations and external meetings/conferences/seminars.
Actively contributes to the strategic direction of the department by recommending expansion or curtailment of activities based on the Global Clinical Development and Global Clinical Trial Organization goals and mission, business drivers, and industry trends and innovations.
Anticipates internal/external regulatory/compliance/scientific issues; serves as a key resource for others in interpreting, developing and applying regulatory/compliance/scientific requirements/issues, for example, new study designs, implications of changes to regulatory changes for a specific region or country.
Begins to identify multi-disciplinary solutions and recommend a course of action to project team and/or department-level management, for example, x-functional solutions to the automatic insertion of tables, listings and graphs in clinical documents.
Required to make complex decisions and troubleshoot in ambiguous situations across departments.
Presents complex ideas, anticipates potential objections and/or persuades/influences others to adapt a different point of view, when appropriate at a professional level.
Works across departments to test and advance innovative processes and methodologies; encourages curiosity and challenges the status quo to foster innovation.
As required, demonstrates advanced skills in optimizing technology to support scientific/business processes.
Uses a high level of judgment to adapt and/or create standard methods and techniques by applying breadth of knowledge and prior work experience. Has high awareness of own limits and proactively consults others to ensure quality of judgment.
As required, writes key documents and reviews the documents prepared by Medical Writers.
Advanced degree in the Life Sciences with 10 years of relevant career experience or PhD with 6+ years relevant career experience.
10 years of experience preparing regulated documents in the pharmaceutical and/or biotech industry; at least 3 years in a project or team leadership role.
Excellent project management, communication, and cross functional relationship-building skills.
Ability to be successful independently and within a multi-discipline team environment.
Preferred: History of publications and/or presentations at industry meetings
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.
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
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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.
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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.
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Requisition ID: R136712
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