Medical Writer – Woburn, MA
Partner cross functionally with clinical development and operations, regulatory affairs, medical affairs, biostatistics and translational research departments in planning and preparation of high quality clinical and regulatory documents. The writer will maintain working knowledge of Replimune strategic plans and provide writing and editorial assistance on various documents, including clinical study protocols and ICFs, Investigator brochures, regulatory documents, clinical study reports, patient safety narratives, biomarker-related documents, scientific abstracts and publications, healthcare provider and patient education materials and other written materials as requested. This position may also interact with external investigators and vendors in drafting and editing investigator-initiated clinical protocols, reports and publications. The position may also be asked to assist in the drafting and editing of the biomarker-related and pre-clinical study reports, scientific abstracts and peer-reviewed manuscripts. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this position. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Effectively partner cross-functionally in planning and preparation of high-quality clinical documents
- Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production and publishing of documents/dossiers.
- Contribute and oversee the Medical writing team, which includes external vendors
- Contribute to the development of documents, which may include but are not limited to clinical study protocols and amendments, Investigator’s Brochures (IBs), clinical study reports (CSRs), Development Safety Update Reports (DSURs), and other documents, as needed
- Manage several MW projects simultaneously and draft and maintain timelines for document completion (from concept to final signature and publishing)
- Lead document review and command resolution meetings with cross-functional teams, as needed.
- Review, edit, and ensure quality of documents in collaboration with internal functional area representatives or external contractors, as needed
- Ensure document content and style complies with applicable regulatory requirements, SOPs, and company standards
- Ensure consistency of facts and style within and across documents as feasible and appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation
- Write, edit, and/or review SOPs, and assist in inspection readiness programs
- Develop document templates, work instructions, style guides, and department-related processes, and perform or support related training
- Ensure a consistent style of presentation of documents to maintain quality and ease of review.
- Perform format and/or content quality control (QC) review of clinical study documents and other submissions written by other medical writers ensure accuracy and consistency.
- Works with relevant teams to obtain accurate information and data for written materials
- Assist management in projecting resources and perform administrative duties
- 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 a cross functional team
- Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness.
- Other duties as assigned.
- Bachelor’s degree in science or medical related field required
- Master’s degree preferred
Experience and skill requirements:
- 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.
- Strong project management skills in guiding and working with cross-functional representatives through the composing or updating clinical documents in a timely and high-quality manner
- Responsible for maintaining working knowledge of Replimune scientific and clinical strategies to enable rapid and consistent written documentation
- 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
- 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 geographically dispersed environment
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.