2 Senior Medical Writer jobs in whatjobs
Job Description
Our client, a prominent pharmaceutical company at the forefront of medical innovation, is seeking a highly experienced Senior Medical Writer to contribute to their dynamic research and development division. This role offers a hybrid work arrangement, allowing for a balance between remote flexibility and in-person collaboration as needed. You will be responsible for the creation of high-quality, scientifically accurate documents for regulatory submissions, clinical trial publications, and other essential medical communications. This includes developing clinical study reports, investigator brochures, manuscripts, and abstracts. The ideal candidate will possess a strong understanding of pharmaceutical drug development processes, regulatory guidelines (e.g., ICH, FDA, EMA), and therapeutic areas. Exceptional writing, editing, and proofreading skills are paramount, along with the ability to interpret complex scientific data and present it clearly and concisely. You will collaborate closely with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to ensure the accuracy and completeness of all documentation. This position requires meticulous attention to detail, strong project management abilities, and a commitment to meeting strict deadlines. You will play a crucial role in disseminating vital medical information to healthcare professionals and regulatory bodies worldwide, contributing significantly to the company's mission of improving patient health. We are looking for a self-starter with excellent communication skills and a proactive approach to problem-solving. Join a team that values scientific integrity and impactful communication.
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Job Description
Our client is seeking a highly experienced and skilled Senior Medical Writer to join their fully remote pharmaceutical team. This crucial role involves the development of high-quality scientific and regulatory documentation to support drug development and regulatory submissions. The ideal candidate will possess a deep understanding of clinical trial processes, pharmaceutical regulations, and medical terminology, with a proven ability to translate complex scientific data into clear, concise, and accurate documents. You will work collaboratively with cross-functional teams to ensure timely and compliant creation of essential documents.
Key responsibilities will include:
Key responsibilities will include:
- Authoring, editing, and reviewing a variety of regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), protocols, informed consent forms, and regulatory submission documents (e.g., INDs, NDAs).
- Ensuring all documentation is scientifically accurate, grammatically correct, and compliant with relevant guidelines (e.g., ICH, FDA, EMA).
- Collaborating closely with clinical development, regulatory affairs, biostatistics, and medical affairs teams in a remote setting.
- Managing multiple writing projects simultaneously, adhering to strict deadlines and project timelines.
- Interpreting clinical trial data and translating it into clear and compelling narratives.
- Staying up-to-date with regulatory requirements, industry best practices, and emerging trends in medical writing.
- Contributing to the development and maintenance of company style guides and templates.
- Providing guidance and mentorship to junior medical writers.
- Participating in cross-functional team meetings and contributing to strategic discussions.
- Reviewing and providing feedback on documents authored by other team members.
- Ensuring consistency and accuracy across all related project documentation.
- Facilitating the review and approval process of documents by internal and external stakeholders.
This advertiser has chosen not to accept applicants from your region.
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