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Associate Medical Writing Director
4 weeks ago
Job Title: Associate Medical Writing Director
Job Location: Reading UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
Location : Permanent HomebasedThe Associate Director Medical Wrting is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to crossfunctional project teams with minimal oversight to ensure that clinical documents (eg Investigators' Brochures IBs Clinical Study Reports CSRs and marketing authorization submission documents) accurately and consistently present key datadriven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous logically organized and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers.
Essential Functions Of The Job (Key Responsibilities)
- Develop regulatory documents for submission to regulatory agencies globally in accordance with ICH and other global guidelines standards and processes and Incyte authoring standards as applicable in adherence with study/project timelines and corporate objectives.
- Lead manage and coordinate all internal and external clinical medical writing activities associated with the preparation compilation and submission of applications to regulatory authorities globally for the assigned programs/compounds.
- Participate in crossfunctional meetings to provide input regarding medical writing deliverables timelines and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg Protocols and Statistical Analysis Plans) as appropriate.
- Lead or participate in crossfunctional process improvement initiatives.
- Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
- Mentors more junior medical writing staff.
- Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- At least 7 years medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
- Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
- Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Strong verbal written and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
- Demonstrated ability to independently lead the development review and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
- Proficient in MS Word. Experience with an electronic document management system and templates is required.
- Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution).
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link.
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Key Skills
EMR Systems,Post Residency Experience,Occupational Health Experience,Clinical Research,Managed Care,Primary Care Experience,Medical Management,Utilization Management,Clinical Development,Clinical Trials,Leadership Experience,Medicare
Employment Type : Full Time
Vacancy: 1
