Principal Medical Writer, Medical Affairs (Clinical)

Company: ProPharma Group
Location: Clifton Park
Posted on: May 16, 2022

Job Description:

Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.Job DescriptionThe Principal Medical Writer, Medical Affairs is responsible for researching, writing, and editing medical affairs documents by applying functional expertise and medical affairs knowledge. The position is expected to exhibit excellent written and oral communication and presentation skills, and to demonstrate expert level technical expertise and background in the use of medical writing templates and software. Additionally, they will also be responsible for ensuring compliance to company regulations, internal procedures, applicable industry standards (e.G., GPP3, ICMJE, CONSORT, STROBE) and policies in cooperation with colleagues and clients.Essential Functions IncludeThe Principal Medical Writer independently leads all aspects of the medical writing process including organization, content, timelines, and resource requirements.Experience and ability to lead publication planning according to industry standards and in accordance with client's product development goals.Demonstrates technical expertise and background in the use of medical writing templates and software and ability to create relevant document templates as needed.Independently leads the document preparation process, including but not limited to: literature search/selection, content development, receive and review primary outputs, draft and distribute documents for review, and incorporate/resolve comments with all contributors and/or reviewers.Leads the activities of the project team, including contract employees or vendors (on-site or external), and provides review and substantive editing of contributions, ensuring resolution of issues.Serves as an expert in advances and technological changes in medical affairs services within the pharmaceutical / device / biotech industries and promotes those that will increase the company's effectiveness and profits.Serves as a led on medical affairs on cross-functional teams and task forces relative to projects, process, and standards.Leads collaboration with colleagues for the purpose of attaining bid opportunities.Develops and delivers in-house staff and external training.Applies effective risk assessment and management principles to identify and address project risks and resolves problems.Promotes the firm's reputation through high quality project outputs and good client relations.Work related travel as required.Other duties as assigned.Qualified Candidates Must HaveQualificationsM.S./M.A. in a relevant clinical and/or scientific discipline as a minimum, doctorate level preferred. Bachelors degree will be considered with appropriate level of experience.Minimum 7 years' experience in a relevant medical writing role in the pharmaceutical/CRO industry/biotechnology industry.Expert level, working knowledge of current requirements and guidelines applicable to medical affairs/medical communications documents e.G., GPP3, ICJME.Strong verbal and written communication skills.Strong computer knowledge including Microsoft Office products.CMPP certification, or ability to obtain this certification, required.Ability to independently develop and manage schedules and budgets.Strong knowledge of applicable GPP3, ICJME and other applicable industry standards and guidance documents.Ability to independently manage multiple projects simultaneously and mentor others in the same, according to sound project management principles.Ability to understand, interpret, and synthesize clinical and scientific data at an expert level and train others to perform this function effectively.Effective written and oral communication skills; ability to write, type,express or exchange ideas; ability to convey information/instructions accurately.Ability to interact in a professional and positive manner with clients and co-workers.Expert level of understanding of the criteria for medical affairs services in the pharmaceutical, medical device and biotech industries.Strong understanding of the bidding/proposal process in these industries.Proven record with problem solving, project tracking, budgeting, and facilitation of efficient communication between the client and the team.Quality orientation and high attention to detail.Flexibility to work occasional weekends and evenings.Additional InformationAll candidates must be legally eligible to work in the United States.We are an equal opportunity employer. M/F/D/V***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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