Medical Writer Consultant (Part time)
215 First Street Cambridge, MA 02142 US
General Scope and Summary
Searching for a detail-oriented, resourceful, integrative thinker for a contract role that is responsible for performing the QC of clinical and regulatory documents (protocol, CSR, IB, clinical sections of clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations and maintaining te department's document QC standards. The Medical Writer Consultant is responsible for ensuring that clinical data is presented accurately and for organizing and managing the reviews for these documents. This position will function under the guidance and direction of the head of the Medical Writing department. The successful candidate will be an independent and proactive, with experience working in a clinical development environment.
Roles and Responsibilities Perform quality control (QC) review of clinical study reports and other documents written by other Medical Writers. Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management to ensure high quality clinical and regulatory documents are prepared and submission ready, including protocols, study reports, investigator brochures, etc. according to company and agency guidelines in order to support drug development under strict timelines. Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers. Function as an integral part of the Medical Writing team, which includes external vendors. Ensure a consistent style of presentation of documents to maintain quality and ease of review. Keep management informed on progress of documents and other project-related information. Assist management in projecting resources and perform administrative duties as requested, such as slide preparation, development of work instructions, etc. Contribute to the design and maintenance of templates/standards for protocols/reports in accordance with ICH guidelines and Medical Writing best practices. Represent Medical Writing on cross-functional teams. Collaborate with and support department leadership to ensure continuous improvement and high standards for quality and productiveness.
Education, Experience and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, and good conflict management and negotiation skills. Experience (3+ years) in management of Clinical/Regulatory documents as a Medical Writer, or equivalent, and presenting relevant specialist qualifications; Bachelor’s degree in a clinical, scientific, or industry-related discipline is strongly encouraged. Working knowledge of ICH and US regulatory requirements is required. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. Familiarity with the requirements for preparation of key clinical and regulatory documents. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, work simultaneously on multiple projects, and independently complete high-quality documents according to tight timelines. Strong team player that has a customer service approach and is solution-oriented. Possesses strong written and verbal communication skills.
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