Become A Senior Medical Writer

* Working with the clinical team, the Senior Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, and Patient Safety Narratives.
* Opportunities to write or contribute to other Regulatory documents such as Clinical Summaries and Briefing Documents may be provided.
* Represent medical Writing at cross-company and TA meetings.
* o Drive document development meetings;
* o Articulate document strategy and timelines;
* o Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.
* o Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
* Manage processes and organize priorities; Solve problems; Foster collaboration to resolve conflict

* Provide scientific publications writing/editing support, ensuring successful preparation of high-quality submission/presentation-ready documents at the direction of publication authors.
* Provide medical writing support for multiple assets within a therapeutic area(s).
* Execute all activities related to the preparation of scientific publications (ie, clinical manuscripts, abstracts, posters, and oral presentations).
* Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects.
* Interface with external experts (eg, physicians, other health care professionals) and staff from other functions (eg, Clinical, Medical Affairs, Statistics, Data Management, PK) to ensure accurate and timely completion/delivery of information, including addressing conflicting demands, and review of scientific publications.
* Serve as a department representative on product teams.
* Communicate deliverables needed, writing process, and timelines to team members.
* Provide direction and guidance to external medical writers, as assigned, ensuring a high-quality and timely work product, and adherence to Publication Policy and associated Procedures.
* Serve as medical writing lead on scientific publications, and work with the Publications Team(s) on publication strategies.
* Learn and apply knowledge of therapeutic area and asset to scientific publishing projects.
* Perform literature searches, as needed, for drafting publication content.
* Interpret literature information and make recommendations for application to scientific publications,
* Understand, assimilate, and interpret sources of information with appropriate guidance/direction from authors and product team members.
* Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify that results are consistent with study data.
* Convert relevant data and information into a form that meets publication needs, ensuring required documentation is obtained.
* Explain data in manner consistent with the target audience(s) and journal/congress requirements.
* Confirm completeness of information to be presented.
* Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress guidelines, and follow applicable company Publication Policy and Procedures.
* Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate.
* Ensure project information in publication records and resourcing tools are accurate and up-to-date.
* Act as Subject Matter Expert for assigned teams regarding publications-related computer-based technologies (eg, Datavision).
* May mentor and provide guidance to more junior medical writers or external vendor/agencies.
* Contribute to department initiatives/activities that impact medical publishing practices/processes.
* Responsible for compliance with applicable Corporate Policies and procedures.
* Must continually train/be compliant with all current industry and company requirements as they relate to scientific publications.
* Qualification
* Minimum of Bachelor’s Degree required.
* PhD, PharmD, Master’s Degree preferred.
* Relevant professional certification/credential (eg, CMPP, AMWA) is a plus.
* years of medical/scientific writing experience in the pharmaceutical/health care industry, academia, or related experience (eg, medical communication agency, clinical/scientific research) required.
* Knowledgeable of US and international regulations, requirements, and guidances associated with scientific publications.
* Ability to assimilate and interpret scientific content, and translate information for appropriate audience.
* Working knowledge of statistical concepts and techniques required.
* Expert in word processing, flow diagrams, and spreadsheets.
* Excellent working knowledge of software programs in Windows environment.
* Microsoft Office and Internet navigation proficiencies essential.
* Working knowledge of Datavision publication management system is a plus.
* Experience in working with collaborative, cross-functional teams, including project management experience.
* Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
* Good business communication skills.
* Learns fast, grasps the 'essence,' and can change the course quickly when needed.
* Raises the bar and is never satisfied with the status quo.
* Creates a learning environment, open to suggestions and experimentation for improvement.
* Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
* Equal Opportunity Employer Minorities/Women/Veterans/Disabled

* Act as Lead Medical Writer, with limited guidance from supervisory staff, and maintains consistent high quality and efficiency.
* Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed.
* Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
* Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance.
* Offers proactive solutions and advice to customers as appropriate to experience.
* Reviews and monitors budget for assigned projects, including identification of out of scope activities, and ensures that revenue is recognized as appropriate.
* Provides senior review, and guidance for documents prepared by junior staff.
* May coordinate Medical Writing activities for a series of full-service projects, with focus on efficiencies, consistency, client liaison, and tracking

* This senior position is responsible for the creation of clinical, scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards.
* Writes and edits clinical and scientific reports including summaries from raw data for submission to regulatory agencies for in-company use, comprehensive literature reviews, exhibits and other projects requiring skill in medical communication.
* Coordinates and completes the writing of Clinical Evaluation Reports (CERs) to provide clinical evidence that supports the safety and effectiveness of relevant products globally.
* Essential job Functions:
* Manage, prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per applicable SOPs.
* Manage internal NPD and consultant/ vendor relationships related to completion of clinical evaluation reports.
* Ensure compliance to the applicable regulations and guidance documents.
* Budget planning and budget management related to these activities.
* Perform gap analyses and revise existing CERs for legacy products against the Medical Device Regulation.
* Working with a multifunctional team, authors assigned protocols, final study reports, manuscripts for publication in peer-reviewed biomedical journals, meeting abstracts, internal reports, and presentations.
* Generate and track timelines.
* Follows through on all tasks and ensures quality results.
* May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
* Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.
* Participates in post-market surveillance activities by leading routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
* Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents.
* Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
* Maintains knowledge of current internal and external standards, regulations and technologies related to this function.
* Coordinates with various departments (e.g., Regulatory, R&D, Clinical Sciences, and Quality) to access and identify the necessary preclinical, clinical and technical information.
* Coordinate external medical writing support/needs, as applicable.
* Provides mentoring/coaching of new hires and/or junior associates, where appropriate.
* Fiscal/Budgetary Responsibilities: The ability to accomplish job functions within a specified budget that may fluctuate depending on the project.
* No direct budgeting responsibilities initially with the position; however, this may be adapted based on the aptitude of the individual.
* Customer and Key Contacts: Ability to work with a variety of multidisciplinary internal and external customers.; Ability to work independently with minimal supervision and accountable for managing multiple projects concurrently

* To prepare documents that are compliant with company's standards, ICH and GCP guidelines and that are approved by the project team, as appropriate.
* To plan, schedule and track all assigned medical writing activities in close cooperation with the teams to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle.
* To work with Medical Writing Management for regular project updates, production and review of assigned documents.
* To take responsibility for ensuring that medical writing deliverables meet the project specifications and produced within the timelines to defined quality, and content standards.
* To maintain metrics and KPIs for their project and contribute to the process of continuous