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Senior Medical Writer

Employer
Sage Therapeutics
Location
Working from Home
Start date
Jul 30, 2022

View more

Discipline
Clinical, Clinical Documentation, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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, and clinical sections of clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations. The Senior Manager, Medical Writing 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

  • 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 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 of 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.

Education, Experience 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

  • 5+ years of experience as a medical writer, or equivalent, and presenting relevant specialist qualifications.

  • Bachelor’s degree in a clinical, scientific, or industry-related discipline.

  • Working knowledge of ICH and US regulatory requirements is required.

Preferred Qualifications

  • 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 an 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, work simultaneously on multiple projects, and 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.

  • Possesses strong written and verbal communication skills.

  • Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

  • Excitement about the vision and mission of Sage.

Employment Type:Employee

Number of Openings:1

Job ID:R001309

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Company

Sage is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner.

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Stock Symbol:

SAGE

Find Us
Website
Phone
617-299-8380
Location
215 First Street
Cambridge
MA
02142
United States
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