Senior Director, Medical Writing

Syndax Pharmaceuticals is looking for a Senior 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 is looking for a motivated and experienced senior medical writer as a Senior Director to be responsible for creating, authoring, and leading the management of clinical and nonclinical regulatory documents to support marketing authorization applications including an anticipated NDA/BLA filing, as well as study protocols, Investigator Brochures, Clinical Study Reports, briefing books, Annual Reports and INDs in support of ongoing clinical development, and clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts).

Key Responsibilities: 

• Provide strategic direction within the Medical Writing team
• Build expert operational/business processes for deliverables within Medical Writing, including simplification and improvements of processes
• Conducts quality control review of complex and/or highly confidential documents for internal and external communications
• Develop and drive continuous improvements, including tracking of OKRs (objectives and key results) and metrics
• Provides expert review of plain language summaries ensuring scientific interpretation of data is communicated appropriately for a common/lay audience and oversight of vendors to ensure deliverables meet expectations
• Provide expertise in developing and/or optimizing technologies to augment ways of work for all functions within Medical Writing Science, including support of execution team with resolution of roadblocks and interdependencies
• Determines resourcing for different groups within MWS to ensure all deliverables are met with high quality
• Oversees hiring activities for different groups within MWS
• Writes, reviews, and edits the following:
  • Regulatory Documents: clinical and non-clinical modules of NDAs and MAAs, clinical protocols, clinical study reports, investigator’s brochures, annual reports, DSURs, INDs, IMPDs, and other regulatory documents in conjunction with the project team
  • Publications: Manuscripts, abstracts, poster presentations, oral presentations

• Drives document writing and review processes, by managing document content and presentation of content, and developing timelines in collaboration with team members
• Ensures consistency across documents in a program and supports consistency in company documents, including through the development of document templates.
• Guides the team in the generation of documents and takes the lead in resolution of document problems
• Works cross-functionally to evolve document preparation and document content practices, to improve quality or efficiency
• Represents medical writing function as an integrated member of clinical study teams
• Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
• Manages outsourced writing projects with contract medical writers as necessary
• Supports the development and maintenance of SOPs for the function and writing tools, such as templates and style manuals, and can provide training within the department and across departments
• Oversees quality control (QC) of documents/supports other writers by QCing documents
• Proactive problem solver, exercising sound judgment and appropriate flexibility within a dynamic environment
• Acts as an authoritative resource within specialty area to internal and external resources
• Works effectively with colleagues from other departments in team situations   

Desired Experience/Education and Personal Attributes:

• Bachelor’s degree and 10+ years of hands-on medical writing, with experience at a senior level for 7+ years. Experience should have been gained directly in pharmaceutical/biotechnology companies and include authoring a wide range of documents (e.g., protocols, IBs, CSRs, briefing books, PIPs, Orphan Drug Applications, documents contributing to global submissions, such as NDAs and MAAs) from inception through completion.
• Proven ability to act as lead author on different types of clinical and regulatory documents, including project management
• Highly developed interpersonal skills with demonstrated experience in multi-team management in a matrix environment, mentoring, coaching, performance management, building high performance teams and resource planning
• Able to set and communicate goals and strategic vision for the groups within MWS
• Experience with the oncology therapeutic area
• Ability to analyze, summarize and interpret clinical data
• Expertise in MS WORD, with the ability to solve technical problems with documents and templates
• Knowledge of FDA and ICH guidelines
• Excellent written and oral communication skills, including functional literacy
• Understanding of the scientific process and clinical research
• Familiarity with industry trends for clinical documents and international dossier preparation, including electronic document submissions
• Experience working on complex projects, within cross-functional teams
• Working knowledge of the eCTD format
• Regular travel may be required for this role

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 $260,000 - $285,000. 

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 (formerly Twitter) 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.

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