Director, Medical Writing – General Medicine/ Le Directeur, rédaction médicale in Rahway, NJ

Director, Medical Writing - General Medicine/ Le Directeur, rédaction médicale - Merck & Co. - Rahway, NJ - work from home job Company: Merck & Co. Job description: Job Description The Director, Medical Writing is responsible for managing medical writing deliverables and teams that support the clinical regulatory writing portfolio. The Director: Provides leadership, strategic, and scientific expertise for the preparation of clinical regulatory documents across multiple programs and/or therapeutic areas (e.g., identification of and developing strategic plans for document deliverables, timelines, resources, review cycles, and escalation/mitigation process). Independently leads and authors clinical regulatory documents (e.g., study protocols, pivotal clinical study reports, clinical sections of submissions, regulatory responses) per company and regulatory requirements. Demonstrates in-depth expertise as a subject matter expert in document planning and authoring and interpretation of data, using own judgment and prior work experience. Is recognized as a significant scientific contributor and works collaboratively on cross-functional teams while demonstrating an in-depth understanding of team and project leadership responsibilities. Applies advanced knowledge of clinical development, relevant regulations, disease areas, and company products. Demonstrates an understanding of the pharmaceutical industry beyond clinical research. Applies advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics. Demonstrates expertise in medical writing-specific tools and technology platforms. Provides leadership in initiatives to improve medical writing processes and standards. Provides scientific and operational mentorship, coaching, and project oversight to support other medical writers. May have management of direct reports including assignment of resources, professional development, and performance management. Qualifications, Skills, and Experience Degree in a scientific discipline (e.g., life sciences, pharmacy, or medicine). Bachelor’s degree with 12+ years, master’s degree with 10+ years, or doctorate degree with 6+ years of relevant career experience, including experience leading and preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to independently lead and prepare any clinical regulatory document (e.g., study protocols, clinical study reports, clinical sections of submissions, regulatory responses) per regulatory requirements and industry guidelines. Ability to critically analyze and present clinical data clearly and objectively. Demonstrated critical thinking and problem-solving capabilities with an ability to innovate and drive change. Experience managing complex writing projects and leading project teams of medical writers and cross-functional members. Excellent oral and written communication and presentation skills. Technical expertise in typical office applications (e.g., Microsoft Office Suite) and in shared document systems (e.g., SharePoint) and concepts of structured content management. 2-4 years of people management experience with direct reports preferred. MRLGCTO MW20 #eligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with 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. 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 Current Contingent Workers apply 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 if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: 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. 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: $159,200.00 - $250,700.00 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 . 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: Hybrid, Remote Work Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Director, Medical Writing - General Medicine/ Le Directeur, rédaction médicale - Merck & Co. - Rahway, NJ - work from home job Expected salary: Location: Rahway, NJ Director, Medical Writing - General Medicine/ Le Directeur, rédaction médicale - Merck & Co. - Rahway, NJ - work from home job Job date: Sat, 19 Aug 2023 06:34:26 GMT Apply for the job now! Director, Medical Writing - General Medicine/ Le Directeur, rédaction médicale - Merck & Co. - Rahway, NJ - work from home job Apply tot his job Apply To this Job