Essential Functions: 

• Positively contributes to departmental growth by working cross-functionally on the continuous development/improvement of medical writing/quality control processes to ensure that work is high quality, uniform, complete, managed appropriately, and meets ProPharma and client standards. 

• Leads medical writing business development efforts (capabilities meetings, bids/contracts, proposal development, budget review, and bid defenses; travel may be required).  

• Organizes and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.). 

• In collaboration with other medical writing leadership, defines and manages medical writing and quality control resource needs, and communicates with recruiting and business development in a timely and effective manner.  

• Ensures appropriate communication on project- and program-related matters with other medical writing leadership, internal functional area heads, and internal resources/consultants.  

• Independently manages medical writing and quality control program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, and study reports, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents). 

• Independently provides medical writing project management oversight of client(s) to develop and maintain new and existing client relationships and manage medical writing deliverables and resourcing needs. 

• Independently leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing/quality control deliverables. 

• Manages direct line reports to ensure completion of medical writing/quality control deliverables on time and within budget. 

• Performs manager/peer review of documents written/reviewed by direct line reports and other medical writers/quality control editors, as required. 

• Supervises and mentors less experienced medical writers/quality control editors on complex projects. 

• As needed, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents). 

• Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. 

• Ensures accurate billing of time to projects, provides oversight and approval of resource time recorded in ProPharma and client time tracking systems, and reviews monthly accruals and invoices, as required. 

• Other duties as assigned. 

Necessary Skills and Abilities: 

• Ability to help lead the medical writing department, manage issue escalation, identify areas of concern or inefficiency, and propose solutions for consideration by management team to improve overall efficiency and quality of deliverables.  

• Expert knowledge of clinical research principles and expert ability to interpret and present clinical data and other complex information. 

• Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. 

• Advanced understanding of regulatory submission requirements and processes. 

• Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. 

• Exceptional leadership, project/time-management, communication, and problem-solving skills with a high attention to detail and quality. 

• English language proficiency and familiarity with American Medical Association (AMA) style. 

• Ability to understand budgeting, forecasting, and resource management. 

• Strong experience in relationship building, strategic collaboration on key business accounts, and provision of exceptional customer service. 

• Thinks proactively, takes initiative, and willingly takes on new challenges. 

• Works effectively in a collaborative team environment. 

• Skilled in process improvement, especially as it applies to medical writing and quality control. 

• Strong negotiation and relationship management skills. 

• Skilled in business development, specific to medical writing/quality control, and ability to deliver capabilities presentations and participate in bid defense meetings. 

• Availability for occasional domestic and/or international travel (valid passport), including overnight stays. 

• Demonstrates a growth mindset and positive outlook in all work activities. 

• Demonstrated ability to lead, develop, and coach others in the medical writing/quality control leadership track. 

Educational Requirements: 

• Bachelor’s degree or higher, preferably in medical or scientific discipline.  

Experience Requirements: 

• Minimum of 7 years of experience in writing/quality control review of clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. 

• Minimum of 5 years of experience in project and resource management. 

• Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a casebycase basis.