General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for overseeing and leading the medical writing function and providing strategic input to the planning process when medical writing will be involved in core team processes and creation of key deliverables. The purpose of this job is to create and to manage documents and reviews for clinical and regulatory documents (eg, protocol, CSR,IB,clinical sections of clinical trial and marketing authorization applications, periodic annual reports) according to company guidelines and international governmental regulations; to manage people resources (internal and external); and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (ie Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) and demonstrated experience managing the project work of other internal and external medical writers.
Roles and Responsibilities (Essential Functions)
- Work with leads from various functional areas 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
- Provide strategically effective directions and development of department initiatives designed to establish best practices and efficient cross-functional collaboration.
- Oversee and manage the work of the medical writing department. This includes training, mentoring, setting the department structure and team assignments, helping the team to manage workload, and providing active performance management focused on growth and development.
- Provide leadership to the department, encourage active participation in career/professional development activities; work with the Medical Writers to encourage collaboration and provide opportunities for team building.
- Ensure a consistent style of presentation of documents to maintain quality and ease of review.
- Provide Direction and guidance to the Medical Writing team on the development of standards, and production of high-quality deliverables.
- Provide input and collaborate with management on goals and metrics
- Be accountable for setting and managing department budget and negotiating outside contracts.
- Build a strong internal team of medical writers and develop a network of external writers to ensure flexibility and quality deliverables.
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, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action.
- MS or equivalent in biological science with 10+ (of BS with 15+) years of medical writing experience in the pharmaceutical industry
- Expertise in drug development, clinical research, medical terminology, study design, and the regulatory requirements for clinical and regulatory documents
- Specific experience in neuroscience, psychiatry, or a related field is ideal
- Expertise in the 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 disbursed environment
- Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
- Experience in resolving conflicting editorial opinions expressed by team members
- Experience leading teams/people to prepare clinical and regulatory submission documents
- Demonstrated experience mentoring and managing the project work of other medical writers
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- 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.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.Employment Type: Employee Number of Openings: 0 Job ID: R000486 #Biotechnology #Careers #ThisIsSage
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.
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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.
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