Merck Principal Medical Writer - Informed Consent (Remote) in Phoenix, Arizona
The Principal Medical Writer – Informed Consent (PMWIC) is responsible for development and management of medical writing informed consent forms that support the clinical regulatory writing portfolio and our ability to conduct clinical studies. The candidate is capable of working independently and as part of a team to achieve goals.
In this role the Principal Medical Writer:
Is recognized as a significant scientific contributor and subject matter expert in preparation of informed consent documentation.
Applies in-depth knowledge of informed consent medical writing, bioethics and health literacy to support pipeline projects.
Represents functional area in cross-functional team (either internally or externally).
Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of effects on other disciplines.
Leads and manages informed consent writing projects including the design, planning, and preparation of informed consent documentation in support of trial development. Works collaboratively to achieve results.
Solves complex problems associated with informed consent medical writing scope of work and provides options for ambiguous situations across departments.
Oversees the work of other informed consent 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 required education:
Degree in the Life Sciences, Medical Communications, Bioethics or Public Health (post-graduate degree strongly preferred)
Bachelor’s degree with 10+ years; or Masters-level with 8+ years; or PhD with 5+ years of relevant career experience
Required experience and skills:
Degree in the Life Sciences, Medical Communications, Bioethics or Public Health (post-graduate degree strongly preferred).
Bachelor’s degree with 10+ years; or Masters-level with 8+ years; or PhD with 5+ years of relevant career experience.
5+ years of relevant medical writing experience.
Demonstrated experience of translating scientific and medical material for a lay audience, and strong knowledge of health literacy principles.
Knowledge of regulatory guidance governing informed consent.
Ability to provide leadership of and management for complex documentation projects and project teams of informed consent medical writers.
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
Excellent oral (including presentation) and written communication.
Excellent project management skills.
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., Rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$130,960.00 - $206,200.00
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R222584
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