Medical Writer (Senior & Principal) – United States in Schwabenheim bei Merck Sharp & Dohme

Job Requirements

This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

Our Medical Writing team is pipelining talent for future openings for Senior and Principal Medical Writers. 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, and innovative medicine.

In the role of 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.

In the role of 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 Clinical Study Reports, 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.

Work Experience

Minimum education required for Senior Medical Writer:

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

Minimum education required for Principal Medical Writer:

• Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.

Required experience and skills for Senior Medical Writer:

• Ability to prepare, with minimal supervision, a subset of clinical regulatory documents e.g., Clinical Study Reports (CSR), Investigator’s Brochure (IB), clinical sections of Investigational New Drug Application (IND)/Investigational Medicinal Product Dossier (IMPD) and Common Technical Document (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 Ap