Senior Medical Writer Jobs

General Scope and Summary

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for a role that is responsible for planning and preparing 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. The Senior Medical Writer is responsible for presenting clinical data objectively in a clear, concise format, 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, proactive medical writer with experience working in a clinical development environment.

Roles and Responsibilities

• Collaborate with and support the department leadership to ensure continuous improvement and high standards for quality and productiveness.
• Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in the planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines to support drug development under strict timelines.
• Represent Medical Writing on cross-functional teams.
• Keep management informed on progress of documents and other project related information.
• Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
• Ensure a consistent style of presentation of documents to maintain quality and ease of review.
• Function as an integral part of the Medical Writing team, which includes external vendors.
• Contribute to the design and maintenance of templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
• Work effectively with company document management system and related tools, templates, and procedures to ensure efficient production and publishing of documents and dossiers.
• Assist management in projecting resources and perform administrative duties as requested.

Experience, Education 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.

Basic Qualifications

• Bachelor’s degree in a clinical, scientific, or industry-related discipline.
• 3+ years of experience as a medical writer.

Preferred Qualifications

• Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.
• Familiarity with the requirements for preparation of key clinical and regulatory documents.
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
• Strong team player that has a customer service approach and is solution-oriented.
• Experience in successfully resolving conflicting editorial opinions expressed by team members.
• Working knowledge of ICH and US regulatory requirements is required.
• Master’s degree preferred.
• Excitement about the vision and mission of Sage.
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
• Possesses strong written and verbal communication skills.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• 5+ years of medical writing experience preferred.
• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
• 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.
• Working knowledge of other ex-US regulatory requirements is desired.

Benefits and Compensation

The base salary hiring range for this position is $95,068 - $130,719.*

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

• Base salary ranges are periodically reviewed and subject to change. #LI-Remote