• Clinical Technical Editor, Medical Writing (Remote) / Rédacteur/rédactrice technique clinique, Réd

    Merck Des Moines, IA 50381

    Job #2039943427

  • Job Description

    New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

    Our Clinical Research and Pharmacovigilance teams push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

    The Medical Writing Department of the Global Clinical Trial Operations (GCTO) organization prepares a variety of regulated documentation in for the clinical development portfolio. The Clinical Technical Editor (CTE) is a member of the Medical Writing team who is accountable for quality control of clinical documents intended for submission to regulatory agencies.

    In this role the CTE will:

    • Coordinate and perform our Company's Quality Control (QC) process for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, clinical study reports (including administrative appendices), patient narratives, and clinical modules of the common technical document. Oversight of external resources for QC may be necessary.

    • Ensure documents comply with appropriate International Council on Harmonisation and regulatory guidance.

    • Work collaboratively with internal and external medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner.

    • Review and edit clinical documents for clinical development projects in multiple therapeutic areas and at various stages of development according to our Company's SOPs and guidelines to verify:

    • ?Completeness and accuracy of information.

    • Accurate use of grammar and style.

    • Consistency of text with internal document data displays as well as external reference sources.

    • Application of format standards for electronic documents.

    • Compliance with submission-ready standards.

    • Ensure consistent QC and good document practices are followed across internal authors, vendors, and external partners.

    • Work within the document management system to ensure security and version control are maintained.

    • Promote the development, implementation, and periodic review of editorial management procedures.

    • Support medical writers on the use of tools and technologies to facilitate efficient and compliant document delivery

    Education:

    • BA/BS or higher

    Skills and Experience:

    • At least 2 years of editing and/or quality control of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment, with specific experience in the pharmaceutical industry within a clinical development operations function and previous hands-on work with regulatory submission documents preferred.

    Additional Skills:

    • Excellent written English skills.

    • High degree of organization and ability to manage multiple projects at any given time.

    • Attention to detail and dedication to excellence in all aspects of the work.

    • Ability to work under pressure and to work solely and collaboratively with teams.

    • Excellent communication and interactive skills and ability to maintain a positive attitude under pressure.

    • Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat.

    *Can be remote based

    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.

    MRLGCTO

    EligibleforERP

    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

    Click here (~~~) to request this role's pay range.

    New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

    Current Employees apply HERE (~~~)

    Current Contingent Workers apply HERE (~~~)

    Secondary Language(s) Job Description

    Dans ce rôle, le(la) RTC devra :

    • Coordonner et exécuter le processus de contrôle de la qualité (CQ) de notre entreprise pour la documentation clinique qui comprend, sans s'y limiter, les protocoles cliniques, les brochures pour les investigateurs, les rapports d'études cliniques (y compris les annexes administratives), les récits de patients et les modules cliniques du document technique commun. La supervision de ressources externes pour le CQ peut être nécessaire.

    • S'assurer que les documents sont conformes aux directives appropriées de l'International Council on Harmonisation et de la réglementation.

    • Travailler en collaboration avec les rédacteurs médicaux internes et externes, les éditeurs réglementaires et les membres de l'équipe de projet pour fournir des documents cliniques de haute qualité dans les délais impartis.

    • Réviser et corriger les documents cliniques pour des projets de développement clinique dans de multiples domaines thérapeutiques et à divers stades de développement, conformément aux Modes opératoires normalisés (MON) et aux directives de notre entreprise, afin de vérifier :

    • L'exhaustivité et l'exactitude des renseignements.

    • L'utilisation précise de la grammaire et du style.

    • La cohérence du texte par rapport aux affichages de données des documents internes et aux sources de référence externes.

    • L'application des normes de formatage des documents électroniques.

    • La conformité aux normes relatives aux documents prêts à être publiés.

    • Veiller à ce que les auteurs internes, les fournisseurs et les partenaires externes respectent des pratiques cohérentes de contrôle de la qualité (CQ) et de bonnes pratiques documentaires.

    • Travailler dans le cadre du système de gestion des documents pour assurer le maintien de la sécurité et du contrôle des versions.

    • Promouvoir le développement, la mise en œuvre et la révision périodique des procédures de gestion éditoriale.

    • Soutenir les rédacteurs médicaux dans l'utilisation des outils et des technologies afin de faciliter la livraison efficace et conforme des documents.

    Formation :

    • B.A./~~~. ou plus

    Expérience et compétences :

    • Au moins 2 ans de rédaction et/ou de contrôle de la qualité de la documentation scientifique/clinique dans un environnement pharmaceutique, biotechnologique, de recherche clinique ou connexe, avec une expérience spécifique dans l'industrie pharmaceutique au sein d'une fonction d'opérations de développement clinique et un travail pratique préalable avec des documents de soumission réglementaire de préférence.

    Compétences supplémentaires :

    • Excellentes compétences de rédaction en anglais.

    • Haut degré d'organisation et capacité à gérer plusieurs projets à la fois.

    • Souci du détail et souci de l'excellence dans tous les aspects du travail.

    • Capacité à travailler sous pression et à travailler uniquement et en collaboration avec des équipes.

    • Excellentes compétences en matière de communication et d'interaction et capacité à conserver une attitude positive sous pression.

    • Compétences avancées en Microsoft Word (y compris l'utilisation de modèles électroniques Word) et Adobe Acrobat.

    *Peut être basé hors site

    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 (~~~) 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 (~~~)

    Pay Transparency Nondiscrimination

    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., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

    10%

    Flexible Work Arrangements:

    Remote Work

    Shift:

    1st - Day

    Valid Driving License:

    Hazardous Material(s):

    Number of Openings:

    1

    Requisition ID: R166729