PPD Manager, Medical Writing - Medical Writing and Healthcare Communications in Waltham, Massachusetts
MANAGER, MEDICAL WRITING
*We are looking to fill this role in one of our locations in US or Europe as an office-based or home-based employee.
Effective communication of evidence and information is essential to conveying the value of products. With approximately 20 years of experience, our highly trained staff provide medical writing services for the peri- and post-approval phases of the product lifecycle, helping to create a consistency in quality and voice. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.
This position manages the performance and workload of Medical Writers and provides short-term and long-term resource planning in order to assign projects to appropriate and available staff. Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluates timeliness and quality of deliverables. Acts as resource for questions relating to client management, project oversight, and document development. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental and industry standards. Participates in preparation and review of group SOPs and job aids. Evaluates compliance with SOPs on an ongoing basis. Gives capabilities presentations to potential clients and interacts with Business Development to prepare budgets and proposals for Medical Writing projects. Participates in the development and delivery of training programs for Medical Writing. Ensures direct reports are adequately trained and supported with their professional development goals and project assignments.
Essential Duties and Responsibilities (other duties may be assigned):
Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to all document types within the scope of Medical Writing delivery. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOPs and job aids. Evaluates compliance with SOPs on an ongoing basis. Stays updated on the guidelines and requirements of relevant regulatory and industry standards.
Gives capabilities presentations to potential clients and interacts with Business Development to prepare budgets and proposals for Medical Writing projects. Participates in the development and delivery of training programs for Medical Writing.
Develops and maintains training programs for Medical Writing. Ensures that direct reports are adequately trained and supported in growth of relevant skills.
Uses clinical/scientific knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical/scientific data.
Interprets and administers policies, processes, and procedures relevant to document development. Requires full knowledge of own area of functional responsibility.
Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives.
Serves as an expert level consultant to internal and external customers in one or more areas of medical writing for the department (i.e. study documents, publications, medical information).
Able to prepare service level strategies for document development as part of developing client solutions that grow the business and meet client needs.
Manages experienced professionals and/or lower level management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
Supervises Medical Writers. Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve timesheet submissions. Assist staff to forecast project-related costs and timelines for completion. Responsible for hiring and evaluating employees, including recommendation of salary levels and promotions.
Education, Professional Skills & Experience
Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
5 years relevant experience in medical writing, preferably within the pharmaceutical industry.
2+ year of leadership responsibility.
Ability to supervise, evaluate, and mentor departmental personnel.
Ability to oversee assignments, monitor staff workload, and provide guidance for completion of assignments.
Ability to create and modify project timelines, allocate resources, and forecast departmental workload.
In depth knowledge of departmental processes and ability to contribute to improving and developing processes.
Excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present complex data.
Ability to develop, review, and modify proposals and budgets for presentation to clients.
Personal Skills & Competencies
- Effective communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits.
Normal and routine office duties.
Domestic and International travel may be required.
Evidera is a business within Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO) and is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
Evidera offers a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, with social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.
How to Apply:
Please complete your online profile by attaching your CV and a cover letter addressing your suitability for the role.
Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran.
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