Role Description The Senior Scientific Communications Specialist is a professional with scientific, clinical, and therapeutic area expertise, responsible for oversight of staff and client services. The position also provides scientifically accurate and balanced information to internal stakeholders, external healthcare professionals, and consumers in a way that supports business needs; is aligned with regulatory and compliance practices; and is consistent with Medical Affairs and brand team objectives. Qualifications - Advanced degree in pharmacy (PharmD preferred), advanced health care degree, or relevant, equivalent clinical experience. - Fluent in German & English (C1 or C2). - Two to four years of related experience in scientific content review within the pharmaceutical industry, medical education, and/or academia. Requirements - Develop and review content for scientific documents including standard and custom responses, slide decks, dossiers, manuscripts, and other deliverables requested by the client. - Demonstrate ongoing scientific expertise relevant to therapeutic areas, including products, disease state management, and emerging therapies. - Integrate scientific expertise with knowledge of regulatory and compliance guidelines to ensure comprehensive review of materials submitted into approval process. - Create and/or review medical affairs materials and promotional materials. - Apply approved standards of style to created and maintained materials. - Demonstrate proficiency in the use of content management systems as applicable. - Update Standard Response format and content for integration into a global content management system. - Respond to Medical Information Requests (via calls/web/emails/letters) and conduct appropriate scientific information exchanges with the requestors. - Participate in scientific training as appropriate to support assigned brands. - Comply with all guidelines, policies, legal, regulatory, and compliance requirements. - Meet or exceed service levels and targets for internal and external customers. - Participate in training & mentoring of new hires or staff changing support areas. - Serve as a team lead for 1 or more Clients, therapeutic areas, workstreams, or brands. - Coordinate with Client to schedule meetings and training sessions, and ensure that all team members meet all training requirements. - Manage and distribute overall workload for a brand or therapeutic area. - Coordinate, lead, and participate in workstreams, special projects, pilots, or other activities requested by the client. - Serve as key contact for communications between the Client and Med Communications team. - Maintain active role in Quality Assurance processes, including monitoring of performance indicators. - Provide medical information support via multiple venues including virtual presentations and medical meeting booth coverage. Benefits - Remote work opportunity. - Work with a diverse and inclusive team. Company Description Med Communications is committed to providing equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.

• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules. • Lead Writing/Editing complex Clinical Dossiers/Safety Reports. • Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier. • Plan and create timelines to produce assigned documents. • Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team. • Actively contribute to best practices and continuous improvement within the therapeutic Area. • Represent the group in functional and cross functional initiatives/projects when required. • Network and share best practices to ensure efficiency and consistency across product teams. • Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work. • Adhere to the quality control process and ensure all work produced has gone through the correct internal review process. • Maintain a working knowledge of pharmaceutical industry standards and compliance. • Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested. • Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.

• Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. • May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. • Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. • Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes. • May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. • Represent the department at project launch meetings, review meetings, and project team meetings.

• Assist with writing and editing clinical and regulatory documents • Collaborate with internal and external clients • Ensure compliance with quality processes • Participate in project meetings