Job description
Syndax Pharmaceuticals is looking for an Executive Director, Medical Writing
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
Syndax Pharmaceuticals is searching for a creative, resourceful, integrative thinker to provide scientific, leadership and operational expertise to the Medical Writing Team while successfully implementing the vision for the department. The ED of MW contributes to and/or oversees the production of high-quality, regulatory-compliant clinical documents and deliverables and collaborates with other functional leaders in the planning and preparation of documents within the assigned time limits.
Key Responsibilities:
- Provides leadership and oversees management of the medical writing function, building consistent processes to optimize utilization of resources aligned with company priorities.
- Ensures Medical Writing activities and provision of deliverables are linked to program strategy by providing leadership and strategic input to projects/study teams at the organization level.
- Ensures that documents meet quality standards in terms of scientific content, organization, clarity, accuracy, format, and consistency, and adherence to regulatory requirements and company guidelines/styles/processes.
- Ensures that all activities are conducted in compliance with relevant regulatory requirements.
- Leads medical writing team in designing and maintaining templates and standards for clinical documents in accordance with ICH guidelines and medical writing best practices. Ensures consistent support and implementation of medical writing standards across all Syndax’s pre-clinical and clinical programs.
- Oversees documents created and edited by the Medical Writing function to ensure compliance with GCP, ICH guidelines, and eCTD requirements, and adherence to Syndax’s SOPs and style guide.
- Creates, maintains, manages, innovates, and continuously improves medical writing procedures and SOPs; proactively identify opportunities to improve systems and processes and autonomously leads process improvement initiatives within the medical writing space.
- Building and maintaining relationships with internal and external customers - playing a key role in business development-related activities and attending client meetings, writing and reviewing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders.
- Developing financial forecasts, and monitoring revenue, costs & utilization. Providing regular business updates to senior leaders.
- Responsible for driving and promoting organizational process improvement initiatives and creating an environment across the team that encourages others to initiate process improvements.
- Collaborates cross-functionally with internal colleagues to improve quality and efficiency across projects and across the organization.
Desired Experience/Education and Personal Attributes:
- MS with 12+ (or BS with 15+) years of medical writing experience in the pharmaceutical industry; at least five years of people management experience.
- Expertise in drug development, clinical research, medical terminology, study design, and the regulatory requirements for clinical and regulatory documents.
- Extensive experience in medical writing with progressive leadership experience and experience in a pharmaceutical/biotech company.
- Specific experience in oncology 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 and problem-solving abilities, a sense of urgency, and an ability to prioritize tasks, work simultaneously on multiple projects, and 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 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.
Location: Syndax’s corporate office is in New York, NY.
Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $290,000 - $315,000.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
#LI-Remote
