Green Key Resources is hiring: Director Of Medical Writing in Waltham

Job DetailExperience Level DirectorDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000018794Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Shape impactful medical writing strategies in a dynamic hybrid environment. Drive regulatory submissions and collaborate across clinical development programs. Enjoy leadership opportunities and professional growth in this strategic role.Job DescriptionOverviewLead strategic medical writing efforts, ensuring alignment with regulatory and clinical objectives to support impactful submissions and deliverables.Develop and execute document strategies that enhance compliance and consistency across clinical and regulatory documentation.Collaborate with cross-functional teams to drive excellence in clinical and regulatory submissions.Provide leadership and mentorship to medical writing staff, fostering professional growth and operational efficiency.Champion process improvements, inspection readiness, and adoption of innovative tools and methodologies.Contribute to strategic planning and resource allocation in collaboration with senior leadership.Ensure timely delivery of milestones by proactively addressing risks and challenges.Operate within a hybrid work model, balancing onsite and remote collaboration effectively.Key Responsibilities & DutiesOversee medical writing deliverables across diverse clinical programs, ensuring quality and compliance.Lead the development of document strategies for complex regulatory submissions, including NDA, BLA, and MAA filings.Author, review, and approve clinical and regulatory documents, maintaining scientific rigor and consistency.Manage internal and external resources, ensuring adherence to performance and quality standards.Collaborate with cross-functional teams to influence and align regulatory strategies.Implement solutions to mitigate risks and ensure successful milestone achievement.Drive operational excellence through continuous process improvements and technology integration.Support departmental goals and contribute to long-term strategy development alongside senior leadership.Job RequirementsBachelor’s degree in a relevant scientific field; advanced degree preferred.Minimum of 10 years of experience in medical writing or related domains.Proven leadership experience managing teams and external vendors in matrixed environments.Expertise in leading global regulatory submissions, including NDA, BLA, and MAA filings.Broad therapeutic area knowledge; neuroscience experience is advantageous.Exceptional written and verbal communication skills with a focus on scientific accuracy.Ability to prioritize and manage competing tasks effectively in dynamic settings.Hybrid work model requiring onsite presence three days per week; relocation support available.