Overview
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values :
United : We Collaborate for a Common Goal.
Audacious : We Are Bold and Innovative.
Dedicated : We Give Our Full Commitment.
Candid : We Are Honest With Each Other .
People are at the center of everything we do, and when it comes to our employees, we make it personal . With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity tocontribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.
Join us, as we reshape the future.
The Sr. Medical Writer (MW) will provide writing assistance on various documents, including safety narratives, clinical study reports (CSRs), Development Safety Update Reports (DSURs), and other documents, as needed. This position will be responsible for coordinating the development of safety narratives (including drafting) and the compilation of the appendices for CSRs. The MW will coordinate the QC performed by external resources. 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.
This position can be based either in our Woburn office (stronglyl preferred) or be a remote role
- Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.
Responsibilities
Effectively partner cross-functionally in planning and preparation of high-quality clinical documentsWork effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents.Drives the process of development of clinical documentsContribute to the development of documents, which may include but are not limited to clinical study protocols and amendments, IBs, CSRs, DSURs, and other documents, as neededSummarize results presented in graphical, tabular, and / or listing formatManage several MW projects simultaneously, including oversight of external writers, and maintain timelines for document completionCoordinate document review and drive resolution meetings with cross-functional teams.Review, edit, and ensure quality of documents in collaboration with internal functional area representatives or external contractors, as neededEnsure document content and style complies with applicable regulatory requirements, SOPs, and company standardsEnsure consistency within and across documents as appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentationDevelop and / or update document templates, work instructions, style guides, and department-related processes (SOPs), and perform or support related trainingEnsure a consistent style of presentation of documents to maintain quality and ease of reviewMay perform quality control (QC) reviews of clinical study documents as neededWorks with relevant teams to obtain accurate information and data for written materialsProvide teams a working knowledge of ICH guidelines and medical writing best practicesRepresent Medical Writing on a cross functional teamCollaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness.Qualifications
Educational requirements :
Degree in science or medical related fieldMaster’s degree or higher preferredExperience and skill requirement :
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.Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management systemAbility to work both independently and collaboratively with a team in a geographically dispersed environmentDemonstrated 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 timelinesExperience in successfully resolving conflicting editorial opinions expressed by team membersStrong team player that has a customer service approach and is solution orientedAttention to detail and the ability to work individually, within a multidisciplinary team, as well as with vendorsPossesses strong written and verbal communication skillsBackground, Knowledge, And Experience
Has a minimum of 3 years of medical writing experience (minimum of 1 year of experience for individuals with a PhD, PharmD, MD, or equivalent)Has a strong understanding of the fundamentals of clinical document development and documentation formatting within the industryWorking knowledge of ICH and medical writing best practices is requiredWorking knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminologyUnderstanding of the fundamentals of clinical development and regulatory affairs (e.g. from working in a similar or an adjacent group in industry)Proven ability of critical thinking, problem solving, and leading cross-functional teamsExperience in oncology strongly preferredJ-18808-Ljbffr
