Sr. Medical Writer at Pharmaceutical Company in Cambridge, Massachusetts, United States —
- Pharmaceutical Company
- Cambridge, Massachusetts, United States USA
- 5/17/20 2020-05-17
Job ID: 6043201
We are searching for a creative, resourceful, integrative thinker for a contract role that is responsible for planning and preparing clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations. The Contract Senior Medical Writer is responsible for presenting clinical data objectively in a clear, concise format, and also 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, proactive, experienced medical writer with experience working in a clinical development environment.
Roles and Responsibilities
- Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, 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.
- Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
- Keep management informed on progress documents and other project related information.
- Assist management in projecting resources,and perform administrative duties as requested.
- 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 the department leadership to ensure continuous improvement, and high standards for quality and productiveness.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.
- Experience (3+ years) 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 other ex-US regulatory requirements is desired.
- 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
- 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, to work simultaneously on multiple projects, and to independently complete high-quality documents according to tight timelines
- Experience in successfully resolving conflicting editorial opinions expressed by team members
- Strong team player that has a customer service approach and is solution oriented
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors