We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Director of Medical Writing.

Key Responsibilities

• Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
• Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
• Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
• Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
• Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
• Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
• Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance.
• Helps define and implement best practices for the responsible use of AI within medical writing workflows.
• Provides guidance to less experienced medical writers and external vendors.

Ideal Candidate

• Bachelors in science (advanced degree is a plus), with 8+ years of experience in medical writing in the pharmaceutical or biotech industry.
• Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner
• Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships
• Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment
• Experience with independently authoring a range of scientific documents and the ability to oversee such authoring done by third parties
• Detail-oriented, with exceptional organizational and project management skills
• Proficient in using scientific writing tools (eg, Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.

The anticipated salary range for candidates for this role will be $160,000-$180,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

We are seeking a Senior Associate, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. You will have the opportunity to support the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will be a data steward of regulatory information, working closely with Regulatory Operations.

Key Responsibilities

• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness
• Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards
• Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones
• Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation
• Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments)
• Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness
• Support inspection readiness activities (e.g., TMF health checks, document completeness reviews)
• Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

Ideal Candidate

• BS (or equivalent) in related scientific discipline
• 2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred)
• Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently
• Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders
• Proven proficiency in MS Word, Excel, Power Point; SharePoint/Teams (preferred)
• Experience working in Veeva Regulatory Information Management (RIM) platform and eCTD submissions (preferred)
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year.

The anticipated salary range for candidates for this role will be $120,000-$135,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

We are seeking a Senior Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Director of Regulatory Affairs, you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role, you will lead the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams.

Key Responsibilities

• Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs, among others
• Support the data collection and cross-functional authorship for regulatory documents. Proofread, edit, and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions
• Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission
• Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed
• Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
• Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members
• With mentoring and guidance from the regulatory affairs leadership team, understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner
• Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables, timelines, and objectives are met

Ideal Candidate

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline
• Regulatory Affairs Certification (RAC) credential preferred
• A minimum of 5 years of regulatory experience working in drug development in the biopharmaceutical industry
• Experience interacting with health authorities including FDA and EMA
• Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally
• Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $155,000-$175,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.