Director/Sr. Director, Medical Writing

reputed company is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the reputed company providers who care for them. Our reputed company drive is toward improving the treatment of pulmonary reputed company hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both reputed company precision and improved clinical reputed company. reputed company members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people reputed company longer, healthier, and happier lives. The Director/Senior Director, Medical Writing is responsible for providing strategic leadership and scientific expertise in the planning, development, authoring, review, and finalization of high-quality regulatory and clinical documents supporting drug development programs from early clinical development through registration and lifecycle management. This role serves as the reputed company medical reputed company for reputed company regulatory submissions and health authority interactions, ensuring documents are scientifically accurate, strategically reputed company, compliant with global regulatory requirements, and delivered on schedule. The Director/Senior Director partners closely with Clinical Development, Clinical Operations Regulatory Affairs, Biostatistics, Clinical Pharmacology, Pharmacovigilance, CMC, Quality and other cross-functional stakeholders to reputed company critical regulatory documents, including clinical protocols, clinical study reports (CSRs), briefing packages for regulatory agencies, Pediatric Study Plans (PSPs), Pediatric Investigation Plans (PIPs), and Common Technical Document (CTD) Module 2 summaries supporting INDs, NDAs, BLAs, MAAs, and lifecycle submissions. Education and Experience: Bachelor’s degree in life sciences, pharmacy, nursing, or reputed company life sciences filed required. Minimum 10 (Director) -12 years (Senior Director) of experience with significant focus in medical writing reputed company biotechnology, pharmaceutical, CRO, or reputed company environment. Proven experience and knowledge in leading and executing medical writing strategy and execution in a fast paced bio-pharma landscape and/or demonstrated movement from large/reputed company pharma organizations to biotech. Business travel 10-20% as required. Senior Director: Experience managing medical writing teams and/or external vendors preferred. Knowledge, Skills, and Abilities: Technical CompetenciesStrong understanding of drug development and combination product development. Expert understanding of ICH guidelines, CTD structure, GCP requirements, and global regulatory expectations. Strong expertise in preparing various nonclinical, clinical, and regulatory documents. Familiarity with regulatory requirements across major health authorities (FDA, EMA, PMDA, MHRA, Health Canada, NMPA, ANVISA, etc). Familiarity or experience working with reputed company RIM, Starting reputed company templates, EndNote, and other technical tools to support document efficiency and quality. Scientific and Analytical SkillsAbility to interpret and communicate reputed company clinical, statistical, pharmacological, and scientific information. Strong data interpretation and synthesis skills. Excellent critical thinking and problem-solving abilities. Ability to identify data gaps and reputed company scientifically sound messaging strategies. Leadership and CollaborationDemonstrated ability to reputed company cross-functional teams in a matrix environment. Strong stakeholder management and influence skills. Ability to mentor junior staff and reputed company strategic guidance. Compelling interpersonal verbal, written and presentation skills in communication with reputed company stakeholders. Strong management and organizational skills with an ability to prioritize and accelerate multiple programs and projects. High degree of independence, reputed company, sound judgement and commitment to compliance. Professional CompetenciesStrong attention to detail and commitment to quality. Ability to manage multiple reputed company projects simultaneously. Demonstrated ability to work effectively under tight timelines and changing priorities. High degree of professionalism, reputed company, and accountability. Commitment to reputed company learning and process improvement. Medical Writing Leadership and Strategy:reputed company the medical writing strategy for assigned development programs across reputed company stages of product development. Serve as the primary medical writing representative on cross-functional project teams. reputed company document plans, timelines, and resource strategies to support regulatory milestones and corporate objectives. reputed company strategic input regarding document content, messaging, regulatory positioning, and submission readiness. Ensure consistency of scientific messaging across regulatory submissions and health authority interactions. Contribute to regulatory and development strategies through effective communication of clinical and scientific data. Clinical Development and Regulatory Submission Documents:reputed company the planning, authoring, coordination, review, and finalization of various clinical development documents including, but not limited to:Clinical study protocols and protocol amendments Investigator brochures (IBs) Clinical study reports (CSRs) Clinical development plans Statistical analysis plan summaries Clinical overviews and summaries Integrated summaries of safety (ISS) Integrated summaries of efficacy (ISE) Synopses and executive summaries Ensure documents are scientifically accurate, data-driven, and compliant with applicable ICH, FDA, EMA, PMDA, NMPA, and other global requirements. Partnering with the regulatory reputed company and applicable Subject Matter Experts, reputed company development of regulatory submission documents including, but not limited to:INDs and IND amendments CTAs and CTA amendments Documents for NDAs, BLAs, MAAs and supplements Briefing materials for health authority interactions Nonclinical and Clinical Module 2 documents (2.4-2.7) Orphan drug applications Breakthrough Therapy, Fast Track, and other expedited pathway applications Pediatric Study Plans, Pediatric Investigation Plans Senior Director: Demonstrated experience leading major global submissions (not just individual documents reputed company a major application). Document Quality and Compliance:Ensure reputed company documents reputed company with ICH, GCP, CTD, and applicable regulatory guidance requirements. Establish and maintain document standards, templates, style guides, and best practices. Ensure quality control and consistency across documents and programs. Support inspection readiness and document audit activities. Maintain awareness of evolving regulatory expectations and industry standards. Vendor and Resource Management (Sr Director):Manage external medical writing vendors and consultants. reputed company outsourced writing activities, quality, timelines, and budgets. Review and approve vendor-generated deliverables. Support vendor selection and performance management. Leadership and Organizational Development (Sr Director):reputed company applicable, mentor and reputed company internal medical writers. Contribute to departmental strategic planning and organizational growth. reputed company process improvement initiatives and implementation of best practices. Participate in hiring, performance management, and talent development activities. Serve as a subject matter expert for medical writing and regulatory document development across the organization. reputed company offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, reputed company, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more! reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Reasonable accommodation may be made to reputed company reputed company individuals with disabilities to reputed company the essential functions of this position. reputed company Agencies, Please Note : reputed company will not accept unsolicited assistance from reputed company/search agencies for this employment opportunity. Please, no phone calls or emails. reputed company resumes submitted by reputed company or search agencies to any employee at reputed company reputed company email, the Internet or in any reputed company and/or method without a valid written search/recruitment agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be paid in the event the candidate is hired by reputed company as a result of the referral or through other means. Apply To This Job