Job Description

Date posted: Jan 30, 2023



City: Laval



Country/Region: CA



Type of Contract: Unlimited contract



Job Requisition ID: 2186




Medical and Scientific Writing Manager




.
JOB TITLE: Medical and Scientific Writing Manager


DEPARTMENT: Global Clinical Development CMO Office Biometric & US Medical Writing


REPORTING TO: Director, US Head of Medical and Scientific Writing


Location: This position is remote anywhere in Canada
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SUMMARY OF ROLE:


The Medical and Scientific Writing Manager will be an active contributor/lead author of regulatory and scientific documentation, will manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, will mentor junior writing staff, and will manage external vendor writers\xe2\x80\x99 deliverables. Document examples include but will not be limited to clinical protocols, clinical study reports, investigator\xe2\x80\x99s brochures, and clinical sections of investigational new drug applications and marketing applications. Strategic regulatory documents such as agency responses and briefing packages will also be authored/managed. The manager will be responsible for the creation of English-language medical writing deliverables at Servier, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards.


Specific Responsibilities:

• The Medical Scientific Writing manager will ensure that clinical regulatory documents (eg, study reports, study protocols, clinical summaries/overviews, investigator\xe2\x80\x99s brochures, scientific publications, contributions to response documents, and other global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
• Activities (performed with minimal supervision) will include, but will not be limited to editing, writing, development and maintenance of timelines, project management, and participation on project teams.
• Will serve as the main medical writing contact on study teams
• Will coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents
• Will ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
• Will mentor and manage the work of junior writers as needed.
• Will manage the work and deliverables of contract/vendor writers, as needed.
• Will participate in the preparation of responses to questions from regulatory agencies and write briefing packages, other strategic regulatory documents such as accelerated review applications, and assist with materials for presentations at agency meetings and advisory committee meetings as needed.
• Will maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Will work cross-functionally to update procedures or practices as needed to remain within regulatory compliance and to improve internal quality and efficiency.

Skills and Education:
Mandatory:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor\xe2\x80\x99s degree required.
• 5+ years of medical writing experience (dependent upon graduate degree)
• Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA)
• Global regulatory submission experience
• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed and critically evaluate the outsourcing strategy.
• Demonstrated ability to remain flexible should priorities change (judgment and decision making) during project execution.

The applicant must demonstrate:

• Excellent verbal and written communication skills
• Exceptional organizational skills and attention to detail
• Project management skills (MS Project experience preferred) and familiarity with GCP and ICH guidelines
• Technical skills with relevant software for authoring such as MS Word and EndNote (ability to use PleaseReview and an abbreviation manager/QC tool is desirable)

The applicant must be able to:

• Manage multiple projects with competing priorities
• Work within a study team with minimal supervision
• Work in a global team environment with ability to maintain strong relationships with the global medical writing management and local US MW, Biometric management

Desirable:

• Expertise with lay language summaries and disclosure-related activities

Other Relevant Information:
Some domestic and international travel may be required.
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