Associate Director of Scientific Publications and Medical Affairs

In conjunction with the VP, Scientific Communications develop and update the scientific communications plans (including manuscripts and congress plans).

• Oversee and contribute to the preparation of high quality content in posters, manuscripts, podium presentations and educational materials, according to established timelines, procedures and on budget.

• Write manuscripts and posters, prepare podium presentations, under the guidance of the VP Medical Affairs, VP Scientific Communications, oversee and contribute with external authors, as appropriate

• Manage external vendors, including the Medical Communications agency, in assisting with medical content planning and execution

• Manage external and internal resources in the development of educational materials and event planning to meet objectives in a cost-efficient and timely manner, effectively using project management skills to track and coordinate activities.

• Identify and engage external medical and scientific experts when appropriate, for participation in advisory boards and as consultants for content development

• Ensure that strategically aligned scientific communication points and key data are included and that statements and conclusions are accurate and supported by appropriate data.

• Participate on relevant project teams, task forces as appropriate

• Oversee and/or contribute to the development/editing of other important medical communications to support the including: briefing documents, written communications, Frequently Asked Question documents, slide decks, medical information letters Responsibilities

•Overall management of all Scientific Documents that are developed by Medical Affairs.

•Develop process for tracking publication and medical communications initiatives.

•Manage internal and external review of manuscripts, posters and presentations, ensuring internal and external stakeholder concerns are addressed.

•Develop Medical Affairs Educational Material and Presentations, including MSL presentations.

•Develop Standard Response Documents (SRDs) and Frequently Asked Questions (FAQ).

•Implement the use of electronic system (Veeva) for review and approval of MSL materials and SRDs.

•Development and maintenance of e-Medical Information sites for Alkermes products

•Contribute to ensuring the overall Compliance process and managing the operational needs of the unit Duties •Manage vendors providing medical communication and information services to external customers on Alkermes products

•Coordinate and conduct training and mentoring of all new Medical Information personnel

•Provide scientifically accurate and balanced responses to medical inquiries from global internal and external customers about Alkermes products 4) Coordinate the submittal of balanced scientific written and verbal responses of unsolicited requests for information on Alkermes products for approved and non-approved uses

•Interface with cross-functional teams to proactively gather insights to develop FAQs and standard responses •Prepare FAQs on Alkermes products for call center to use to respond to requests for information

•Update and initiate new medical information response letters for medical information call center

•Evaluate medical inquiry trends and reactively develop FAQs and standard responses

•Assure that adverse event reports and product complaints received by Medical Affairs are identified and handled per corporate policy.

•Coordinate with safety for reporting purposes of adverse events and product complaints

•Coordinate with MSL Director and external vendors the development of materials used for MSL presentations

•Assist in training of sales and other employees

•Participate in training of new department employees

•Maintain departmental procedural guidelines and standard operating procedures (SOPs)

•Evaluate and manage vendors involved in medical/drug information, medical education

•Coordinate literature review and bibliography services and database

•Develop educational presentations