Principal Medical Writer - Oncology/ Le rédacteur médical principal

Job Description

The Principal Medical Writer is responsible for development and management of medical writing 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 regulatory clinical documentation.
• Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product 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 impact on other disciplines.
• Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results.
• Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
• Oversees the work of other 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.
• Provide leadership of and management for complex documentation projects and project teams of medical writers.

Minimum education required:

• Degree in the Life Sciences.
• Bachelor's degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.

Required experience and skills:

• 5-10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of 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.
• 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, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.

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 du développement et de la gestion des livrables de rédaction médicale qui soutiennent le portefeuille de rédaction clinique réglementaire et est capable de travailler de manière indépendante pour atteindre les objectifs.

Nos équipes cliniques et de pharmacovigilance gèrent les études afin de fournir les données de sécurité et d'efficacité requises pour l'approbation réglementaire de nouveaux médicaments potentiels, vaccins et nouvelles indications pour les produits existants. Nous nous assurons de mener des essais cliniques de haute qualité en intégrant une technologie de pointe et en appliquant des normes scientifiques et éthiques rigoureuses.

Dans ce rôle, le rédacteur médical principal :

• Est reconnu(e) comme un(e) contributeur/-rice scientifique important(e) et un(e) expert(e) en la matière dans la préparation de la documentation clinique réglementaire.

• Applique une connaissance approfondie de la rédaction médicale réglementaire et du domaine thérapeutique / produit de recherche pour soutenir les projets en attente. Représente le domaine fonctionnel dans une équipe interfonctionnelle (en interne ou en externe).

• Produit une documentation de haute qualité et opportune conformément aux attentes. Interprète et applique sa connaissance des exigences réglementaires/conformités/scientifiques en utilisant son propre jugement, son expérience professionnelle et une large appréciation de l'impact sur les autres disciplines.

• Dirige et gère des 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 ex : les rapports sur la sécurité chimique essentiels) et des dépôts de documents (ex : des modules cliniques). Travaille en collaboration avec des collègues de toutes les fonctions pour obtenir des résultats.

• Résout des problèmes complexes associés à l'étendue du travail de rédaction médicale, impliquant des situations ambiguës entre les services et la nécessité de développer de nouvelles options pour les résoudre.

• Supervise le travail d'autres rédacteurs médicaux, en leur fournissant un encadrement scientifique et opérationnel et en les guidant dans la conception, la planification et l'exécution de leurs missions. Fournit une rétroaction à leurs responsables sur les plans de développement et les évaluations du rendement.

• Assure la direction des processus, des normes et des initiatives en matière de rédaction médicale.

Formation minimale requise :

• Diplôme en sciences de la vie.

• Baccalauréat avec au moins 10 ans d'expérience professionnelle pertinente ou maîtrise avec au moins 8 ans d'expérience professionnelle pertinente ou doctorat avec au moins 5 ans d'expérience professionnelle pertinente.

Expérience et compétences requises :

• 5 à 10 ans d'expérience en tant que rédacteur/-rice médical(e) préparant des documents réglementés dans l'industrie pharmaceutique et/ou biotechnologique. Capacité à préparer, sans supervision, tout type de document réglementaire clinique (protocole, rapport sur la sécurité chimique, CIB, sections cliniques de dossier de produit médicinal expérimental et de document technique commun) conformément aux directives de l'entreprise et aux réglementations gouvernementales internationales et à présenter les données cliniques de manière objective dans un format clair et concis, conformément aux directives de l'industrie.

• Assurer la direction et la gestion de projets de documentation complexes et d'équipes de rédacteurs médicaux.

• Expertise technique dans Microsoft Office, Adobe Acrobat, les systèmes de gestion de documents, et connaissance de SharePoint et des concepts de gestion de contenu structuré.

• Excellentes compétences en matière de communication orale (y compris les présentations) et écrite, et de gestion de projet. Connaissance des besoins de l'industrie pharmaceutique au-delà du développement clinique.

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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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:R253650