Merck Principal Medical Writer - Informed Consent (Remote) in Topeka, Kansas
The Principal Medical Writer – Informed Consent (PMWIC) is responsible for development and management of medical writing informed consent deliverables that support the clinical regulatory writing portfolio and is capable of working independently 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 medical 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 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.
Qualifications, Skills and Experience:
Degree in the Life Sciences (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 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., 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
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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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R116904