Sage Therapeutics Associate Director, Medical Writing in Cambridge, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a role that is responsible for managing medical writing vendor(s), documents, and reviews for clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. 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, experienced medical writer with experience in preparing key summary submission documents (eg, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview), and demonstrated experience managing the project work of other outsourced medical writers.
Roles and Responsibilities
Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in 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.
Be hands on and also manage the work of other medical writers (mostly through a strategic partner and possibly internal in the future) to prepare documents. This includes training and mentoring in addition to participation in assessing workload and managing work assignments.
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.
Ensure a consistent style of presentation of documents to maintain quality and ease of review.
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.
Experience, Education and Specialized Knowledge and Skills:
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.
Candidate must have a BS or equivalent in a biological science. An advanced degree, particularly in neuroscience, psychiatry, or related field is ideal.
Candidates must have at least 7 years of experience as a medical writer. Exceptional candidates with less direct medical writing experience but considerable transferrable experience or skills may be considered
Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
Detailed knowledge of requirements for preparation of key clinical and regulatory documents
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 cross-cultural, 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 tight timelines
Experience in successfully resolving conflicting editorial opinions expressed by team members
Demonstrated experience mentoring and managing the project work of other medical writers
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, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
Excitement about the vision and mission of Sage
# of Openings 1
Job Locations US-MA-Cambridge
Posted Date 7/11/2017