Medical Writer
- Maatrom Solution
- 3 to 8 Yrs
- Multi-City, India
- 3 years ago
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Job Description
:The primary responsibilities of the Medical Writing Lead are to establish strategies within the assigned Therapy Area that drives clinical study and regulatory document authoring to highest quality and regulatory standards.
This is a hands-on role, requiring the Medical Writing Lead to independently write or direct writing of medical and regulatory documents.
- Manage medical writing resources (internal and external) assigned to support document development.
- Lead medical writing activities for US, European and other regulatory submissions as assigned.
- Ensure data is presented and documents are written objectively in a clear, concise format and able to withstand examination by regulatory bodies.
- Accountable for own work and that of his/her assigned medical writers such that documents are prepared, reviewed, and approved in a quality and timely manner.
- Accountable for staying within the assigned medical writing budgets and for oversight of all medical writing tasks delegated to external medical writing service providers.
Main responsibilities / job expectations
Leadership / Management
- Lead is an effective team leader capable of working efficiently with minimal oversight and direction within an asset centric matrix organization.
- Collaborates within their assigned study/project teams to ensure all medical writing deliverables for a given study and targeted submission plan are prospectively identified, included in the project plan, adequately resourced and are delivered on time and to quality expectations.
- Develop, and manage medical writers or medical writing service providers; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers
- Contribute to building capabilities and technical skills across the medical writing department.
- Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensures team awareness of developments impacting medical writing standards.
- Determine resource needs based on workload and project priorities and communicate to the Head of Medical Writing in a timely fashion.
- Work with the Head of Medical Writing to develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects.
- Serve as back up to Head of Medical Writing at leadership meetings
Medical Writing
- Lead by example, serving as an expert document author and directing and supervising the authoring of documents within the framework of and in compliance with ICH-GCP, applicable regulatory guidelines, R&D SOPs and other Ipsen policies.
- Conducts searches of scientific literature to place study design considerations and study results in context with other relevant data.
- Collaborate with study teams and other functions including but not limited to regulatory and pharmacovigilance, to ensure assigned documents are developed with medical writer input as early as possible.
- Lead document strategies and messages in a collaborative way with relevant project team subject matter experts.
- Perform critical content reviews, correctly interpret results, identify potential limitations and discuss unexpected findings.
- Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Collaborate with quality lines and relevant study team subject matter experts, to ensure the accuracy and quality of information presented in assigned documents.
- Contribute to formation of key messages in consultation with functional area experts (e.g. Recommending data outputs for collection of specific data, proposing document strategy for filings or responding to health authority requests)
When leading a team of other authors (internal or external), be accountable for timely delivery of high quality, fit-for-purpose documents to the study team.
- Critically review documents produced by writers for scientific content and alignment with company position, clarity, accuracy, and consistency
- Drive use of the EDMS by all contributors in the preparation of key study documents (e.g., protocols, clinical study reports and investigator brochures)
Project Deliverables
- Plan, schedule and track all assigned medical writing activities in close cooperation with clinical operations and medical study team members.
- Deliver assigned documents on or before deadline, promptly alerting study / project teams and Head of Medical Writing of any anticipated delays, information gaps or potential shortcomings in quality.
- Stay within assigned budget
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Medical TranscriptionPharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Medical Writer
Contact Details:
Company: M/s Chauhan CraneLocation(s): Multi-City, India
Keyskills: document management system scientific writing medical communications clinical study medical writing document imaging physician relations healthcare compliance reporting clinical study report
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