Senior Medical Writer - Vaccines (Remote) / Le rédacteur médical principal

Job Description

Our Clinical Research and Pharmacovigilance team 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 Senior Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with

some guidance and oversight to achieve goals.

In this role the Senior Medical Writer:

• Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
• Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
• Represents medical writing in cross-functional teams
• Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines
• Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation
• Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
• Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
• May participate in orientation and coaching of junior team members or contractor writers
• Participates in or leads initiatives to improve medical writing processes and standards

Education Minimum Requirement:

• Degree in a life science, preferably related to pharmacy or medicine

Required Experience and Skills:

• Bachelor's degree with 5+ years; MS with 4+ years; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience
• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations, and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Demonstrated participation in medical writing, document, and project teams
• Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred
• Demonstrated excellent presentation, writing, and 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.

MRLGCTO

MW20

EligibleforERP

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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Secondary Language(s) Job Description

Le rédacteur médical principal est responsable de développer des livrables de rédaction médicale qui soutiennent le portefeuille de rédaction clinique réglementaire et de travailler avec des directives et une supervision qui lui permettront d'atteindre les objectifs.

Dans ce rôle, le rédacteur médical principal :

• Est reconnu comme un contributeur scientifique et un expert en la matière pour préparer certains documents cliniques réglementaires

• Applique ses connaissances de la rédaction médicale réglementaire et du domaine thérapeutique/produit de recherche pour soutenir les projets en attente

• Représente la rédaction médicale dans des équipes interfonctionnelles

• Fait preuve de compétence dans la rédaction, l'édition et la révision de rapports d'études cliniques, de brochures d'investigateurs, de modules de dossier d'enregistrement et d'autres documents réglementaires cliniques conformément aux directives de l'entreprise et d'autres directives, avec une expertise spécifique dans la préparation de protocoles d'études cliniques de phase 1 (volontaires sains) et amendements.

• Interprète les données et applique sa connaissance des exigences réglementaires/conformités/scientifiques relatives à la préparation des documents

• Gère les projets de rédaction médicale, y compris la conception, la planification et la préparation de la documentation clinique à l'appui du développement clinique, des essais et des sections des dépôts

• Résout les problèmes associés à la portée du travail de la rédaction médicale, demande conseil à la direction ou à des tiers au besoin, et exerce des compétences de négociation et de communication avec les membres de l'équipe de projet

• Peut participer à l'orientation et à l'encadrement des collaborateurs juniors ou des rédacteurs contractuels

• Participe ou dirige des initiatives visant à améliorer les processus et les normes de rédaction médicale

Exigences et compétences :

• Diplôme en sciences de la vie, de préférence lié au domaine pharmaceutique ou médical

• Baccalauréat avec 5 ans d'expérience; Maîtrise en sciences avec 4 ans d'expérience; ou doctorat (ex : PhD, MD, DMV, DO, Pharma) avec plus de 3 ans d'expérience professionnelle pertinente

• Expérience démontrée dans la préparation de protocoles d'études cliniques de phase 1 (volontaires sains) et de modifications dans tous les domaines thérapeutiques.

• Capacité à préparer, avec un minimum de supervision, une gamme de documents réglementaires cliniques, y compris les protocoles de phase I et les modifications conformément aux directives de l'entreprise et aux réglementations gouvernementales internationales (ex : l'Union européenne, les États-Unis), et à présenter des données cliniques de manière objective dans un format clair et concis conformément aux directives de l'industrie

• Participation démontrée aux équipes de rédaction médicale, de documentation et de projet

• Expertise technique dans les applications bureautiques typiques (ex : Microsoft Office, Adobe Acrobat) et dans les systèmes de documents partagés (ex : Google Docs, SharePoint).

• Familiarité avec les meilleures pratiques de création concises/lean et utilisation de modèles structurés et de bibliothèques de contenu.

• Compétence démontrée en matière de présentation, de rédaction et de gestion de projet

Nous sommes une société biopharmaceutique axée sur la recherche. Notre mission est fondée sur le simple fait que nous « respectons la science » et que les meilleurs médicaments peuvent impacter considérablement notre monde. Et nous croyons qu'une entreprise axée sur les recherches scientifiques de classe mondiale peut réussir en apportant des innovations aux médicaments et aux vaccins qui ont des effets concrets sur nos patients partout dans le monde.

US and Puerto Rico Residents Only:

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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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, 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:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R246432