Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The Associate Director, Medical Writing is responsible for independently authoring and delivering complex clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level and program-level activities. This position will work directly with the Senior Director, Medical Writing.
You will be responsible for…
- Author and deliver high-quality clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, integrated summaries, and sections of regulatory submissions) in partnership with cross-functional team members
- Coordinate effective document development, review, and approval
- Develop document timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
- Manage and oversee medical writing outsourced to vendors
- Actively contribute to the development of processes and procedures to improve departmental and cross-functional workflows
- Ensure document compliance with company and regulatory guidance
- Build relationships and work collaboratively with study team members
- Develop in-depth study-level and program knowledge
- Contribute to clinical document strategic planning
- Review study and program-level documents for clarity, accuracy, and consistency
- Navigate an electronic document management system and related tools to develop clinical documents
What Knowledge & Experience you'll bring to us...
- Bachelor's degree in relevant discipline required. PhD (or equivalent degree) in molecular biology, genetics, or a related life sciences field preferred
- Typically requires 5+ years of experience in the pharmaceutical/biotechnology industry as a medical writer
- Experience in oncology is preferred but not required
- Self-motivated and nimble with the ability to excel in a fast-paced environment
- Excellent written and verbal communication skills
- Strong interpersonal skills with a proven ability to effectively manage relationships in a virtual work environment
- Ability to analyze, interpret, and summarize complex clinical data
- Strategic thinker who excels at working with cross-functional teams
- Knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
- Strong project management and organizational skills
- Creative problem solver adept at mediating team discussions
- Experience driving process improvements for medical writing
- Attention to detail related to consistency, grammar, syntax, and scientific accuracy
- Proficiency in word processing, templates, table/figure creation, and literature searches
- Local to the Boston area preferred
- An equivalent combination of education and experience may be considered
Behavioral skills to be successful...
- Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
- Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
Flexible work from home options available.