Director, Medical Writing - Oncology (Remote)/ Le Directeur, rédaction médicale

Job Description

This director-level position is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio. The Managing Medical Writer is an integral part of a clinical and/or study team capable of working independently to achieve goals.

The Director is responsible for:

• Leadership of and strategic and scientific contribution to the preparation of regulatory documentation in support of the clinical development pipeline.
• Quality and compliance with internal and external standards.
• Timely and efficient production of English-language clinical regulatory documents using an electronic document management system.
• Must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.
• May have overarching responsibilities for oversight of multiple clinical programs or disease areas.
• Directs teams in development of documentation roadmap (e.g., strategic program level overviews as well as details for specific deliverables, timelines, resources, expected deliverables, review cycles, issue escalation/mitigations, presentations to Sr. Management as needed).
• Leads dossier preparation and writes key documents and/or oversees the writing of others.
• Builds talent and capabilities of medical writing team members through proactive coaching, mentoring and development opportunities.
• Facilitates and collaborates with internal and external stakeholders in support of clinical documentation objectives.
• May include management of direct reports including assignment of resources, professional development and performance management.
• Leads or contributes to process improvement initiatives.
• Degree in the Life Sciences.
• Bachelor's degree with 12+ years; or MS with 10+ years; or PhD with 6+ years relevant career experience.
• 6-12 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.
• 2-4 years of people management experience with direct reports preferred.
• Provide leadership of and management for complex documentation projects and project teams of 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, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.

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

MW20

#clinicalops

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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

Le Directeur, rédaction médicale est responsable du développement et de la gestion des livrables en rédaction médicale qui soutiennent le portefeuille de rédaction clinique réglementaire. Le Directeur, rédaction médicale, fait partie d'une équipe clinique qui est capable de travailler de manière indépendante pour atteindre les objectifs.

Dans ce rôle, le Directeur, rédaction médicale:

Assure une direction et contribution scientifique à la préparation de dossier réglementaire pour soutenir les projets en développement. Assure la qualité et la conformité durant les audits internes et externes Produit une documentation clinique et réglementaire en langue anglaise de haute qualité et en utilisant le système de gestion de dossiers électroniques. Applique sa connaissance scientifique, esprit analytique, son expérience professionnelle, dans l'analyse de données, la préparation de rapports et production de dépôts de documents (ex. des modules cliniques). Peut avoir la responsabilité de plusieurs programmes cliniques ou champs thérapeutiques. Dirige des équipes dans le développement de plan (ex., programme stratégique, ainsi que livrables spécifiques, échéanciers, ressources, livrables, cycle de révision, problèmes à soulever, présentations à l'équipe de direction au besoin). Dirige la préparation de la documentation clinique réglementaire, rédige des documents clés et supervise le travail de rédaction des membres de l'équipe. 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. Travaille en collaboration avec les équipes interfonctionnelles en interne ou en externe relativement aux objectifs de documentation clinique. Peut inclure la gestion d'employé directs incluant la distribution des ressources, le développement professionnel et la gestion du rendement des employés. Dirige ou contribue à l'amélioration des processus en matière de rédaction médicale.

Formation et experience requises (Requirements) :

• Diplôme en sciences de la vie.
• Baccalauréat avec au moins 12 ans d'expérience professionnelle pertinente ou maîtrise avec au moins 10 ans d'expérience professionnelle pertinente ou doctorat avec au moins 6 ans d'expérience professionnelle pertinente.

• 6 à 12 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.
• 2-4 ans d'expérience en gestion de personnel avec employés sous sa responsabilité est préférable
• 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.

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 Know Your Rights

EEOC GINA 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.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:R243411