Precision Medicine Group

Role Description The Medical Director is responsible for leading content development for multiple projects and providing input on strategy while working cross-functionally and with a high level of independence. The Medical Director is responsible for ensuring high quality regarding content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. - Independently develop strategic, high-quality, and medically accurate content for a wide range of medical communications resources for a medium-sized book of business (generally 3 – 4 assigned accounts but varies based on size) which span multiple therapeutic areas. - Collaborate with internal team members to create compelling content that meets client objectives. - Review project briefs and timelines, assign staff, and attend all kick-off meetings. - Review content for scientific accuracy and appropriateness to the project. - Ensure best practices for content development are followed and advise on strategic or client considerations. - Liaise directly with client on strategy and content-related subject matter including medical, legal, regulatory review meetings. - Discuss medical content with external stakeholders including medical professionals, key opinion leaders, and managed care customers as required. - Plan and allocate resources based on business needs in conjunction with other internal stakeholders. - Supervise 2 – 4 medical writers and/or scientific associates directly. - Establish and track individual personal development plans for each team member and provide timely feedback. - Assist in development of new business proposals including target product profiles (TPPs) and/or competitive analyses. - Attend and present at business pitch meetings as needed. - Promote and adhere to Precision Value and Health’s workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration). Qualifications - BA/BS in life sciences. - BA/BS in English combined with experience in a pharmaceutical agency, medical communications company or healthcare advertising. Requirements - 5 – 7 years of experience in the medical communication, pharmaceutical and/or healthcare industry. Skills - Command of American Medical Association (AMA) style. - Strong proficiency with Word, PowerPoint, and Adobe Acrobat. - Strong proficiency with scientific search engines including PubMed and Google Scholar. Competencies - Strong written and verbal communication. - High analytic ability. - Strong self-management, organizational, and time management. - Ability to translate complex scientific concepts for a variety of managed care audiences. - Ability to prioritize deadline-sensitive projects and juggle competing client priorities. - Highly team- and detail-oriented. Preferred Education - Advanced degree in life sciences (PharmD or PhD). Preferred Qualifications - Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences. - Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.). - Ability to develop engaging promotional content. - Managed care experience. Compensation Reasonable estimate of the current range: $117,000 — $165,000 USD. Benefits - Discretionary annual bonus. - Health insurance. - Retirement savings benefits. - Life insurance and disability benefits. - Parental leave. - Paid time off for sick leave and vacation. Equal Opportunity Employer Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

• End‑to‑end project management, including planning, resourcing, timeline development, progress tracking, risk management, and delivery oversight across individual projects and portfolios of work (particularly JCA program's) • Support or lead project management discussions, prepare and maintain project plans, timelines, and reports, and ensure clear communication of status, risks, dependencies, and actions • Monitor scope changes and manage change order processes, clearly documenting impacts on timelines, resources, and budgets • Coordinate internal workflows, facilitating alignment across disciplines, documenting decisions and actions, and supporting monitoring and evaluation of agreed processes and milestones • Play a key role in ensuring on‑time delivery, supporting financial and scope tracking, and escalating risks or resourcing issues to project leadership • Develop and maintain standardized project management tools and templates, ensuring best practices are applied consistently across projects and teams • Support proposal development and study start‑up activities, including timeline development.

• Work closely with scientific project leads and cross‑functional contributors across evidence synthesis, statistics, and health economic modelling. • Responsible for end‑to‑end project management, including planning, resourcing, timeline development, progress tracking, risk management, and delivery oversight. • Support or lead project management discussions, prepare and maintain project plans, timelines, and reports. • Ensure clear communication of status, risks, dependencies, and actions, and monitor scope changes. • Coordinate internal workflows, facilitate alignment across disciplines, document decisions and actions, and support monitoring and evaluation of agreed processes and milestones. • Support strategic portfolio oversight and prioritization, working with senior leadership to balance competing demands and optimize resource allocation.

• Support the quality management system including SOPs, training, and CAPA • Process and maintain documentation for controlled documents • Develop and administer training for employees and/or consultants • Host client/sponsor audits and support regulatory inspections • Coordinate and conduct assessments of potential vendors including vendor audits • Conduct internal audits of quality systems • Conduct investigator site audits • Conduct trial master file audits • Participate in computer systems validation projects • Provide QA consultation and support to assigned project teams • Manage reported quality issues and associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks and identify opportunities for improvement

• Support the audit program and clinical projects to ensure compliance with applicable regulations and Precision procedures • Provide oversight and subject matter expertise to quality and compliance activities • Support project teams during all stages of a clinical study • Support the Quality Management System including SOPs, training and CAPA • Process and maintain documentation for controlled documents, as required • Develop and administer training for employees and/or consultants • Host client/sponsor audits and support regulatory inspections • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted • Coordinate and conduct internal audits of quality systems • Coordinate and conduct investigator site audits • Coordinate and conduct trial master file audits • Participate on computer systems validation projects and systems change control process • Provide QA consultation and support to assigned project teams internally and externally • Support and manage reported quality issues and any associated corrective and preventive actions • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement • Maintains Q&C trackers, databases, metrics, and files • Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

• Creates and maintains the project timeline in MS Project or similar system. • Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File. • Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed. • Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. • Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate. • Creates project-specific email boxes and maintains appropriate access to study team members. • Manages user access to study systems by submitting user requests to the Help Desk or similar. • Orders study supplies and addresses queries on study supplies. • Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor. • Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader. • Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership. • Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable. • May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment). • Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.

• Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. Ensures the distribution of updates to study team members. • Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File. • Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed. • Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. Identifies gaps in training and engages appropriate team members or escalates as needed. • Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate. • Creates project-specific email boxes and maintains appropriate access to study team members. • Manages user access to study systems by submitting user requests to the Help Desk or similar, by reviewing team member access on a defined periodic basis, and document access review. • Orders study supplies and addresses queries on study supplies. • Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor. • Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader. • Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required. • May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance. • May support the translation process of site level documents, as applicable, per local and regional standards. • May act as point of contact for project-related requests for team members, Sponsors, and third party vendors. • Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable. • May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment). • Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.

• Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. Ensures the distribution of updates to study team members. • Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File. • Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed. • Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. Identifies gaps in training and engages appropriate team members or escalates as needed. • Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate. • Creates project-specific email boxes and maintains appropriate access to study team members. • Manages user access to study systems by submitting user requests to the Help Desk or similar, reviewing team member access on a define periodic basis, and document access review. • Orders study supplies and addresses queries on study supplies. • Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor. • Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader. • Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required. • May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance. • May support the translation process of site level documents, as applicable, per local and regional standards. • May act as point of contact for project-related requests for team members, Sponsors, and third party vendors. • Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable. • May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment). • Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.

• Creates and maintains the project timeline in MS Project or similar system. • Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File. • Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed. • Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. • Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate. • Creates project-specific email boxes and maintains appropriate access to study team members. • Manages user access to study systems by submitting user requests to the Help Desk or similar, by reviewing team member access on a define periodic basis, and document access review. • Orders study supplies and addresses queries on study supplies. • Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor. • Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader. • Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required. • May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance. • May support the translation process of site level documents, as applicable, per local and regional standards. • May act as point of contact for project-related requests for team members, Sponsors, and third party vendors. • Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable. • May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment). • Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.

• Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. • Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File. • Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed. • Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. • Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate. • Creates project-specific email boxes and maintains appropriate access to study team members. • Manages user access to study systems by submitting user requests to the Help Desk or similar, by reviewing team member access on a define periodic basis, and document access review. • Orders study supplies and addresses queries on study supplies. • Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor. • Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader. • Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required. • May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance. • May support the translation process of site level documents, as applicable, per local and regional standards. • May act as point of contact for project-related requests for team members, Sponsors, and third party vendors. • Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable. • May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment). • Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.