Sr. Manager, Medical Writing

SUMMARY OF ROLE:

The Sr. Manager, Medical Writing will be responsible for the creation of English-language medical writing deliverables at Servier Pharmaceuticals US (Servier), ensuring the high-quality, timely, and efficient development of nonclinical, clinical, and regulatory documents that comply with internal and external standards. The Sr. Manager, Medical Writing will 1) be the lead author of regulatory and other scientific documentation, 2) manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, 3) mentor junior writing staff, 4) manage external vendor writer activities and 5) be the Medical Writing point of contact for a particular drug development franchise within Servier. Document examples include but will not be limited to nonclinical study reports and CTD modules, clinical protocols, clinical study reports, investigator’s 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 written/managed.

Specific Responsibilities:

• The Sr. Manager, Medical Writing will ensure that nonclinical and clinical regulatory documents (eg, study reports, study protocols, clinical summaries/overviews, investigator’s 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  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 of timelines, project management, and participation on project teams. Will serve as the main medical writing contact on study teams. Will work independently to 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 influence cross-functionally to improve procedures or practices as needed to remain within regulatory compliance and promote internal quality and efficiency.

Skills and Education:

Mandatory:

• Bachelor’s degree in a relevant discipline 5 years of regulatory medical writing experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA)
• Global regulatory submission experience
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed and critically evaluate the outsourcing strategy.

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 (the ability to use PleaseReview and an abbreviation manager/QC tool is desirable) The ability to remain flexible should priorities change (judgment and decision making) during project execution

The applicant must be able to:

• Manage multiple projects with competing priorities Work within a program/franchise 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:

• History of successful preparation and submission of a major regulatory marketing application, including the nonclinical modules Experience with authoring/management of clinical and non-clinical documents for drug development

Other Relevant Information:

Some domestic and international travel may be required