Associate Director, Medical Writing

Replimune Group; Massachusetts; Remote; USD 140,000 - 180,000; Full time

Job summary

A leading company focused on innovative cancer therapies seeks an Associate Director of Medical Writing. This role involves drafting and coordinating clinical documents, ensuring compliance with industry standards, and collaborating with cross-functional teams. Ideal candidates will have a strong background in medical writing, especially in oncology, and demonstrate excellent interpersonal skills.

Qualifications

• Minimum 5 years medical writing experience.
• Strong understanding of clinical document development.
• Demonstrated ability to work collaboratively in a dispersed environment.

Responsibilities

• Coordinate development of clinical documents and QC.
• Collaborate cross-functionally for high-quality document production.
• Manage multiple projects and timelines.

Skills

Interpersonal Skills

Problem Solving

Attention to Detail

Education

Degree in Science or Medical Related Field

Master’s Degree or Higher Preferred

Tools

Microsoft Word

Job description

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 Associate Director, Medical Writing, 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 Associate Director, Medical Writing 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 documents
• Work 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 documents
• Contribute 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 needed
• Summarize results presented in graphical, tabular, and/or listing format
• Manage several MW projects simultaneously, including oversight of external writers, and maintain timelines for document completion
• Coordinate 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 needed
• Ensure document content and style complies with applicable regulatory requirements, SOPs, and company standards
• Ensure consistency within and across documents as appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation
• Develop and/or update document templates, work instructions, style guides, and department-related processes (SOPs), and perform or support related training
• Ensure a consistent style of presentation of documents to maintain quality and ease of review
• May perform quality control (QC) reviews of clinical study documents as needed
• Works with relevant teams to obtain accurate information and data for written materials
• Provide teams a working knowledge of 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.

Qualifications

Educational requirements:

• Degree in science or medical related field
• Master’s degree or higher preferred

Experience 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 system
• Ability to work both independently and collaboratively with a team in a 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 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 multidisciplinary team, as well as with vendors
• Possesses strong written and verbal communication skills

Background, Knowledge, And Experience

• Has a minimum of 5 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 industry
• Working knowledge of ICH and medical writing best practices is required
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
• Understanding 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 teams
• Experience in oncology strongly preferred